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Kanta intraokular penapisan cahaya biru (IOL) untuk melindungi kesihatan makula

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Referencias

Aose 2006 {published data only}

Aose M, Matsushima H, Nagata M, Matui E, Obara Y, Yoshida S, et al. Characteristics of different types of hydrophobic acrylic intraocular lenses and clinical evaluation during early postoperative period. Investigative Ophthalmology and Visual Science2006; Vol. 47:ARVO E‐abstract 610. CENTRAL

Bandyopadhyay 2016 {published data only}

Bandyopadhyay S, Saha M, Chakrabarti A, Sinha A. Effect on contrast sensitivity after clear, yellow and orange intraocular lens implantation. International Ophthalmology 2016;36(3):313‐8. CENTRAL

Barisic 2007 {published data only}

Barisić A, Dekaris I, Gabrić N, Bosnar D, Lazić R, Martinović ZK, et al. Blue light filtering intraocular lenses in phacoemulsification cataract surgery. Collegium Antropologicum 2007;31(Suppl 1):57‐60. CENTRAL

Behrens‐Baumann 2005 {published data only}

Behrens‐Baumann W, Walter S, Muller S, Kuchenbecker J, Lindner H. Comparison of two lOLs: Hoya AF‐ I (UV) VA6013B vs. AF‐1 (UY) YA‐60BB. American Academy of Ophthalmology. 2005:185. CENTRAL

Bhattacharjee 2006 {published data only}

Bhattacharjee H, Bhattacharjee K, Medhi J. Visual performance: comparison of foldable intraocular lenses. Journal of Cataract and Refractive Surgery 2006;32(3):451‐5. CENTRAL

Brøndsted 2014 {published data only}

Brøndsted AE, Sander B, Haargaard B, Lund‐Andersen H, Jennum P, Gammeltoft S, et al. The effect of neutral and blue‐blocking intraocular lenses on circadian photoentrainment. Investigative Ophthalmology and Visual Science2014; Vol. 55, issue 13:4184. CENTRAL

Brøndsted 2015 {published data only}

Brøndsted AE, Sander B, Haargaard B, Lund‐Andersen H, Jennum P, Gammeltoft S, et al. The effect of cataract surgery on circadian photoentrainment: a randomized trial of blue‐blocking versus neutral intraocular lenses. Ophthalmology 2015;122(10):2115‐24. CENTRAL

Brøndsted 2017 {published data only}

Brøndsted AE, Haargaard B, Sander B, Lund‐Andersen H, Jennum P, Kessel L. The effect of blue‐blocking and neutral intraocular lenses on circadian photoentrainment and sleep one year after cataract surgery. Acta Opthalmologica 2017;95(4):344‐51. CENTRAL

Caporossi 2007 {published data only}

Caporossi A, Martone G, Casprini F, Rapisarda L. Prospective randomized study of clinical performance of 3 aspheric and 2 spherical intraocular lenses in 250 eyes. Journal of Refractive Surgery 2007;23(7):639‐48. CENTRAL

Caporossi 2009 {published data only}

Caporossi A, Casprini F, Martone G, Balestrazzi A, Tosi GM, Ciompi L. Contrast sensitivity evaluation of aspheric and spherical intraocular lenses 2 years after implantation. Journal of Refractive Surgery 2009;25(7):578‐90. CENTRAL

Cionni 2003 {published data only}

Cionni RJ. Clinical study results of the AcrySof Natural intraocular lens. American Academy of Ophthalmology. 2003:130. CENTRAL

Cristobal 2005 {published data only}

Cristobal JA, Sierra J, Martin J, Rodriguez NA, Ascaso J. Intraocular lenses with blue light filter. Archivos de la Sociedad Espanola de Oftalmologia 2005;80(4):245‐9. CENTRAL

Cui 2009 {published data only}

Cui H, Hu R, Zhang Y, Lou D. Comparison of pseudophakic visual quality in spherical and aspherical intraocular lenses. Canadian Journal of Ophthalmology 2009;44(3):274‐8. CENTRAL

Cuthbertson 2009 {published data only}

Cuthbertson FM, Dhingra S, Benjamin L. Objective and subjective outcomes in comparing three different aspheric intraocular lens implants with their spherical counterparts. Eye 2009;23(4):877‐83. CENTRAL

Espindle 2005 {published data only}

Espindle D, Crawford B, Maxwell A, Rajagopalan K, Barnes R, Harris B, et al. Quality‐of‐life improvements in cataract patients with bilateral blue light‐filtering intraocular lenses: clinical trial. Journal of Cataract and Refractive Surgery 2005;31(10):1952‐9. CENTRAL

Espíndola 2012a {published data only}

Espíndola RF, Santhiago MR, Kara‐Júnior N. Effect of aspherical and yellow tinted intraocular lens on blue‐on‐yellow perimetry. Arquivos Brasileiros de Oftalmologia 2012;75(5):316‐9. CENTRAL

Falkner Radler 2008 {published data only}

Falkner CI, Binder S. UV‐filter IOL versus yellow blue light‐filter IOL in combined cataract surgery with vitrectomy: a prospective randomized clinical trial. Investigative Ophthalmology and Visual ScienceARVO E‐abstract 1484. CENTRAL
Falkner‐Radler CI, Benesch T, Binder S. Blue light‐filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. American Journal of Ophthalmology 2008;145(3):499‐503. CENTRAL

Hahsler 2004 {published data only}

Hahsler B, Lackinger B, Klemen U. Contrast sensitivity in IOL with blue light filter: a comparison of SN60 and SA60. Klinische Monatsblatter fur Augenheilkunde 2004;221(Suppl 1):S15‐6. CENTRAL

Hahsler 2005 {published data only}

Hahsler B, Lackinger B, Klemen U. Contrast sensitivity in IOL with blue filter: SN 60/SA 60, HOYA‐YA/HOYA‐VA on the F.A.C.T. test facility. Klinische Monatsblatter fur Augenheilkunde 2005;222(Suppl 1):S8. CENTRAL

Hayashi 2006 {published data only}

Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non‐tinted intraocular lenses. British Journal of Ophthalmology 2006;90(8):1019‐23. CENTRAL

Hyunseok 2007 {published data only}

Hyunseok A, Kim SW, Kim EK, Lee AY, Kim T. Comparison of an aspherical IOL with a spherical IOU wavefront analysis and visual quality. American Academy of Ophthalmology. 2007:210. CENTRAL

Kara Júnior 2006 {published data only}

Kara‐Júnior N, Jardim JL, de Oliveira Leme E, Dall'Col M, Susanna R. Effect of the AcrySof Natural intraocular lens on blue‐yellow perimetry. Journal of Cataract and Refractive Surgery 2006;32(8):1328‐30. CENTRAL

Kara Junior 2011 {published data only}

Kara‐Junior N, Espindola RF, Gomes BA, Ventura B, Smadja D, Santhiago MR. Effects of blue light‐filtering intraocular lenses on the macula, contrast sensitivity, and color vision after a long‐term follow‐up. Journal of Cataract and Refractive Surgery 2011;37(12):2115‐9. CENTRAL

Kennis 2004 {published data only}

Kennis H, Huygens M, Callebaut F. Comparing the contrast sensitivity of a modified prolate anterior surface IOL and of two spherical IOLs. Bulletin de la Societe Belge d'Ophtalmologie 2004;2004(294):49‐58. CENTRAL

Kim 2011a {published data only}

Kim JY, Choi JA, Na KS, Joo CK. The effect of yellow tinted intraocular lenses on the result of frequency doubling perimetry after cataract surgery. Korean Journal of Ophthalmology 2011;25(1):29‐32. CENTRAL

Kim 2011b {published data only}

Kim JH, Kim NR, Lee ES, Rho S, Kang SY, Kim CY. Influence of blue light‐filtering intraocular lenses on retinal nerve fiber layer measurements by spectral‐domain optical coherence tomography. Current Eye Research 2011;36(10):937‐42. CENTRAL

Kuchenbecker 2004 {published data only}

Kuchenbecker J, Muller S, Walter S, Lindner H, Behrens‐Baumann W. The comparison of two intraocular lenses: Hoya AF‐1 (UV) VA‐60BB and AF‐1 (UY) YA‐60BB ‐ preliminary results. Klinische Monatsblatter fur Augenheilkunde 2004;221(Suppl 5):S11‐2. CENTRAL

Leibovitch 2006 {published data only}

Leibovitch I, Lai T, Porter N, Pietris G, Newland H, Selva D. Visual outcomes with the yellow intraocular lens. Acta Ophthalmologica Scandinavica 2006;84(1):95‐9. CENTRAL

Marshall 2005 {published data only}

Marshall J, Cionni RJ, Davison J, Ernest P, Lehmann R, Maxwell WA, et al. Clinical results of the blue‐light filtering AcrySof Natural foldable acrylic intraocular lens. Journal of Cataract and Refractive Surgery 2005;31(12):2319‐23. CENTRAL

Mester 2008a {published data only}

Mester U, Holz F, Kohnen T, Lohmann C, Tetz M. Intraindividual comparison of a blue‐light filter on visual function: AF‐1 (UY) versus AF‐1 (UV) intraocular lens. Journal of Cataract and Refractive Surgery 2008;34(4):608‐15. CENTRAL

Monnet 2009 {published data only}

Monnet D, Tépenier L, Brézin AP. Objective assessment of inflammation after cataract surgery: comparison of 3 similar intraocular lens models. Journal of Cataract and Refractive Surgery 2009;35(4):677‐81. CENTRAL

Neumaier‐Ammerer 2010 {published data only}

Neumaier‐Ammerer B, Felke S, Hagen S, Haas P, Zeiler F, Mauler H, et al. Comparison of visual performance with blue light‐filtering and ultraviolet light‐filtering intraocular lenses. Journal of Cataract and Refractive Surgery 2010;36(12):2073‐9. CENTRAL

Nolan 2009 {published data only}

Nolan JM, O'Reilly P, Loughman J, Stack J, Loane E, Connolly E, et al. Augmentation of macular pigment following implantation of blue light‐filtering intraocular lenses at the time of cataract surgery. Investigative Ophthalmology and Visual Science 2009;50(10):4777‐85. CENTRAL

Pandita 2007 {published data only}

Pandita D, Raj SM, Vasavada VA, Vasavada VA, Kazi NS, Vasavada AR. Contrast sensitivity and glare disability after implantation of AcrySof IQ Natural aspherical intraocular lens: prospective randomized masked clinical trial. Journal of Cataract and Refractive Surgery 2007;33(4):603‐10. CENTRAL

Raj 2005 {published data only}

Raj SM, Vasavada AR, Nanavaty MA. AcrySof Natural SN60AT versus AcrySof SA60AT intraocular lens in patients with color vision defects. Journal of Cataract and Refractive Surgery 2005;31(12):2324‐8. CENTRAL

Rocha 2006a {published data only}

Rocha KM, Nose W, Chalita M, Yamada AN, Morimoto L, Bottos K, et al. Wavefront analysis and contrast sensitivity of aspheric and spherical IOLs: a randomized prospective study. Investigative Ophthalmology and Visual Science2006; Vol. 47:ARVO E‐abstract 1502. CENTRAL

Rocha 2006b {published data only}

Rocha KM, Nose W, Chalita MR, Yamada AC, Bottos K, Bottos J, et al. Wavefront analysis and contrast sensitivity of aspheric and spherical IOLs: randomized prospective study. American Academy of Ophthalmology. 2006:200. CENTRAL

Rocha 2007 {published data only}

Rocha KM, Soriano ES, Chamon W, Chalita MR, Nosé W. Spherical aberration and depth of focus in eyes implanted with aspheric and spherical intraocular lenses: a prospective randomized study. Ophthalmology 2007;114(11):2050‐4. CENTRAL

Schmack 2012 {published data only}

Schmack I, Schimpf M, Stolzenberg A, Conrad‐Hengerer I, Hengerer FH, Dick HB. Visual quality assessment in patients with orange‐tinted blue light‐filtering and clear ultraviolet light‐filtering intraocular lenses. Journal of Cataract and Refractive Surgery 2012;38(5):823‐32. CENTRAL

Schmidinger 2008 {published data only}

Schmidinger G, Menapace R, Pieh S. Intraindividual comparison of color contrast sensitivity in patients with clear and blue‐light‐filtering intraocular lenses. Journal of Cataract and Refractive Surgery 2008;34(5):769‐73. CENTRAL

Schmoll 2014 {published data only}

Schmoll C, Khan A, Aspinall P, Goudie C, Koay P, Tendo C, et al. New light for old eyes: comparing melanopsin‐mediated non‐visual benefits of blue‐light and UV‐blocking intraocular lenses. British Journal of Ophthalmology 2014;98(1):124‐8. CENTRAL

Soriano 2006 {published data only}

Soriano ES, Rocha KM, Nose W, Monmoto M, Chalita MR, Chamon W. Correlation between near vision and pupil size in aspheric and spherical IOLs. American Academy of Ophthalmology. 2006:209. CENTRAL

Ueda 2005 {published data only}

Ueda T, Taguchi Y, Tsukahara M, Yamamoto Y, Koide R. Retinal light damage control by blue light‐absorbing intraocular lens. Investigative Ophthalmology and Visual Science2005; Vol. 46:ARVO E‐abstract 808. CENTRAL

Ueda 2006 {published data only}

Ueda T, Ota T, Yukawa E, Hara Y. Frequency doubling technology perimetry after clear and yellow intraocular lens implantation. American Journal of Ophthalmology 2006;142(5):856‐8. CENTRAL

Vuori 2006 {published data only}

Vuori ML, Mantyjarvi M. Colour vision and retinal nerve fibre layer photography in patients with an Acrysof Natural intraocular lens. Acta Ophthalmologica Scandinavica 2006;84(1):92‐4. CENTRAL

Walter 2005 {published data only}

Walter S, Kuchenbecker J, Muller S, Behrens‐Baumann W. A comparison of two intraocular lenses: Hoya AF‐1 (UV) VA‐60BB and AF‐1 (UY) YA‐60BB ‐ preliminary results. Klinische Monatsblatter fur Augenheilkunde 2005;222(Suppl 6):S7‐8. CENTRAL

Wang 2010 {published data only}

Wang H, Wang J, Fan W, Wang W. Comparison of photochromic, yellow, and clear intraocular lenses in human eyes under photopic and mesopic lighting conditions. Journal of Cataract and Refractive Surgery 2010;36(12):2080‐6. CENTRAL

Wirtitsch 2009 {published data only}

Wirtitsch MG, Schmidinger G, Prskavec M, Rubey M, Skorpik F, Heinze G, et al. Influence of blue‐light‐filtering intraocular lenses on color perception and contrast acuity. Ophthalmology 2009;116(1):39‐45. CENTRAL

Yamaguchi 2009 {published data only}

Yamaguchi T, Negishi K, Ono T, Torii H, Dogru M, Yamaguchi K, et al. Feasibility of spherical aberration correction with aspheric intraocular lenses in cataract surgery based on individual pupil diameter. Journal of Cataract and Refractive Surgery 2009;35(10):1725‐33. CENTRAL

Yamaguchi 2011 {published data only}

Yamaguchi T, Negishi K, Ohnuma K, Tsubota K. Correlation between contrast sensitivity and higher‐order aberration based on pupil diameter after cataract surgery. Clinical Ophthalmology 2011;5(1):1701‐7. CENTRAL

Yuan 2004 {published data only}

Yuan Z, Reinach P, Yuan, J. Contrast sensitivity and color vision with a yellow intraocular lens. American Journal of Ophthalmology 2004;138(1):138‐40. CENTRAL

Alexander 2014 {published data only}

Alexander I, Cuthbertson FM, Ratnarajan G, Safa R, Mellington FE, Foster RG, et al. Impact of cataract surgery on sleep in patients receiving either ultraviolet‐blocking or blue‐filtering intraocular lens implants. Investigative Ophthalmology and Visual Science2014; Vol. 55, issue 8:4999‐5004. CENTRAL

Alfonso 2007 {published data only}

Alfonso JF, Fernández‐Vega L, Baamonde MB, Montés‐Micó R. Prospective visual evaluation of apodized diffractive intraocular lenses. Journal of Cataract and Refractive Surgery 2007;33(7):1235‐43. CENTRAL

Chen 2013 {published data only}

Chen C, Du WJ, Shen LT, Wei QH. Comparison of the contrast vision after implanting photochromic, yellow or clear intraocular lenses. International Eye Science 2013;13(5):931‐3. CENTRAL

Chiosi 2006 {published data only}

Chiosi F, Greenstein VC, Braunstein RE, Holopigian K, Seiple W, Sparrow JR. Does a "yellow" tinted IOL adversely affect scotopic and photopic visual performance?. Investigative Ophthalmology and Visual Science2006; Vol. 47:ARVO E‐abstract 304. CENTRAL

Cionni 2006 {published data only}

Cionni RJ, Tsai JH. Color perception with AcrySof natural and AcrySof single‐piece intraocular lenses under photopic and mesopic conditions. Journal of Cataract and Refractive Surgery 2006;32(2):236‐42. CENTRAL

Clarke 1989 {published data only}

Clarke MP, Yap M, Weatherill JR. Do intraocular lenses with ultraviolet absorbing chromophores protect against macular oedema?. Acta Ophthalmologica 1989;67(5):593‐6. CENTRAL

Cunha 2010 {published data only}

Cunha JP, Paiva T, Castanheira‐Dinis A. The eye, the intraocular lens and the circadian rhythm. Journal of Sleep Research 2010;19:189. CENTRAL

Feng 2016 {published data only}

Feng X, Xu K, Hao Y, Qi, H. Impact of blue‐light filtering intraocular lens implantation on the quality of sleep in patients after cataract surgery. Medicine 2016;95(51):e5648. CENTRAL

Gavris 2006 {published data only}

Gavris M, Horge I, Marian N, Popa D, Olaru G, Stepan E. Our experience with Acrysof Natural intraocular lens. Oftalmologia 2006;50(3):94‐8. CENTRAL

Gibson 2008 {published data only}

Gibson GA, Davies LN, Wolffsohn JS. Cognitive and visual function in phakic and pseudophakic eyes: an intraocular lens filter study. Investigative Ophthalmology and Visual Science2008:ARVO E‐ abstract 3342. CENTRAL

Hammond 2010 {published data only}

Hammond BR, Renzi LM, Sachak S, Brint SF. Contralateral comparison of blue‐filtering and non‐blue‐filtering intraocular lenses: glare disability, heterochromatic contrast, and photostress recovery. Clinical Ophthalmology 2010;4:1465‐73. CENTRAL

Hayashi 2009 {published data only}

Hayashi K, Masumoto M, Hayashi H. All‐distance visual acuity in eyes with a nontinted or a yellow‐tinted diffractive multifocal intraocular lens. Japanese Journal of Ophthalmology 2009;53(2):100‐6. CENTRAL

Kraff 1985 {published data only}

Kraff MC, Sanders DR, Jampol LM, Lieberman HL. Effect of an ultraviolet‐filtering intraocular lens on cystoid macular edema. Ophthalmology 1985;92(3):366‐9. CENTRAL

Lak 2007 {published data only}

Lak D, Lubinski W, Sylwestrzak Z, Szych Z, Karczewicz D. Comparative assessment of the course of age‐related macular degeneration in patients after phacoemulsification cataract surgery with implantation of AcrySof Natural SN 60 at and AcrySof SA 60 at lenses. Annales Academiae Medicae Stetinensis 2007;53(Suppl 1):43‐7. CENTRAL

Lavric 2014 {published data only}

Lavric A, Pompe MT. Do blue‐light filtering intraocular lenses affect visual function?. Optometry and Vision Science 2014;91(11):1348‐54. CENTRAL

Mayer 2005 {published data only}

Mayer S, Wirbelauer C, Haberle H, Pham DT. Contrast vision after IOL implantation with or without blue light filter. Klinische Monatsblatter fur Augenheilkunde 2005;222(Suppl 1):S8. CENTRAL

Mayer 2006 {published data only}

Mayer S, Wirbelauer C, Pham DT. Functional results after intraocular lens implantation with or without blue light filter: an intraindividual comparison. Klinische Monatsblätter für Augenheilkunde 2006;223(2):142‐6. CENTRAL

Mester 2008b {published data only}

Mester U, Kaymak H. The aspheric blue light filter IOL AcrySof IQ compared to the AcrySof SA60AT: influence of IOL power, pupil diameter, and corneal asphericity on postoperative spherical aberration. Der Ophthalmologe 2008;105(11):1029‐35. CENTRAL

Mester 2008c {published data only}

Mester U, Kaymak H. Comparison of the AcrySof IQ aspheric blue light filter and the AcrySof SA60AT intraocular lenses. Journal of Refractive Surgery 2008;24(8):817‐25. CENTRAL

Muller 2005 {published data only}

Muller V, Langenbeck J, Muller M, Tetz MR. Intra‐ and interindividual comparison of spherical, aspherical, clear and yellow intraocular lenses (IOL). Klinische Monatsblatter fur Augenheilkunde 2005;222(Suppl 7):S18. CENTRAL

Munoz 2012 {published data only}

Muñoz G, Belda‐Salmerón L, Albarrán‐Diego C, Ferrer‐Blasco T, Fernández‐Porrero A. Contrast sensitivity and color perception with orange and yellow intraocular lenses. European Journal of Ophthalmology 2012;22(5):769‐75. CENTRAL

Nagai 2015 {published data only}

Nagai H, Hirano Y, Yasukawa T, Morita H, Nozaki M, Wolf‐Schnurrbusch U, et al. Prevention of increased abnormal fundus autofluorescence with blue light‐filtering intraocular lenses. Journal of Cataract and Refractive Surgery 2015;41(9):1855‐9. CENTRAL

Nakamura 2006 {published data only}

Nakamura T, Kiuchi Y, Fukui K, Harada J, Fujimoto M. Improving contrast sensitivity with the Acryl‐Foldable yellow intraocular lens. Investigative Ophthalmology and Visual Science2006; Vol. 47:ARVO E‐abstract 302. CENTRAL

Nishi 2013 {published data only}

Nishi T, Taketani F, Ueda T, Ogata N. Comparisons of amplitude of pseudoaccommodation with aspheric yellow, spheric yellow, and spheric clear monofocal intraocular lenses. Clinical Ophthalmology 2013;7:2159‐64. CENTRAL

Rodriguez‐Galietero 2005a {published data only}

Rodríguez‐Galietero A, Montés‐Micó R, Muñoz G, Albarrán‐Diego C. Blue‐light filtering intraocular lens in patients with diabetes: contrast sensitivity and chromatic discrimination. Journal of Cataract and Refractive Surgery 2005;31(11):2088‐92. CENTRAL

Rodriguez‐Galietero 2005b {published data only}

Rodríguez‐Galietero A, Montés‐Micó R, Muñoz G, Albarrán‐Diego C. Comparison of contrast sensitivity and color discrimination after clear and yellow intraocular lens implantation. Journal of Cataract and Refractive Surgery 2005;31(9):1736‐40. CENTRAL

Shpak 2012 {published data only}

Shpak AA, Maliugin BE, Fadeeva TV. The effect of yellow filter intraocular lens on the macula after cataract phacoemulsification in patients with age macular degeneration. Vestnik Oftalmologii 2012;128(4):48‐51. CENTRAL

Stopyra 2012 {published data only}

Stopyra W. Evaluation of colour vision according to type of implanted artificial foldable intraocular lens. Klinika Oczna 2012;114(4):266‐9. CENTRAL

Sun 2007 {published data only}

Sun K, Huang Y, Luo S, Lu Q, Zhang W, Xie J, et al. The clinical investigation of early visual function in cataract patients after implantation with aspheric intraocular lens. Eye Science 2007;23(1):43‐7. CENTRAL

Tognetto 2003 {published data only}

Tognetto D, Toto L, Sanguinetti G, Cecchini P, Vattovani O, Filacorda S, et al. Lens epithelial cell reaction after implantation of different intraocular lens materials: two‐year results of a randomized prospective trial. Ophthalmology 2003;110(10):1935‐41. CENTRAL

Wen 2012 {published data only}

Wen HM, Han LC, Cong RC, Li HX. Compare the pseudophakic accommodation of three type monofocal intraocular lens implantation eyes. International Eye Science 2012;12(7):1311‐3. CENTRAL

Wohlfart 2007 {published data only}

Wohlfart C, Tschuschnig K, Fellner P, Weiss K, Vidic B, El‐Shabrawi Y, et al. Visual function with blue light filter IOLs. Klinische Monatsblätter für Augenheilkunde 2007;224(1):23‐7. CENTRAL

Ji 2013 {published data only}

Ji HL, Xiao W, Pu W. Mesopic visual quality after three kinds of aspheric acrylic monofocal intraocular lenses. International Eye Science 2013;13(8):1609‐12. CENTRAL

Li 2009 {published data only}

Li HW, Guo HK, Zhang HY, Jin HY, Chen YL, Liu MY. Comparative analysis of visual quality after aspheric intraocular lens implantation. International Journal of Ophthalmology 2009;9(11):2092‐6. CENTRAL

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Shi D, Zhang JS. Impact of different intraocular lens design on the wave‐front aberration of pseudophakic eyes. International Journal of Ophthalmology 2008;8(1):71‐3. CENTRAL

Nishi 2015 {published data only}

Nishi T, Saeki K, Obayashi K, Miyata K, Tone N, Tsujinaka H, et al. The effect of blue‐blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK‐IOL colour study). BMJ Open 2015;5(5):e007930. CENTRAL

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Aose 2006

Methods

Study design: RCT

Study grouping: parallel group; no further details provided

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age: not reported

Non‐blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age: not reported

Non‐blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age: not reported

Non‐blue‐light filtering IOL group 3

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age: not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: YA‐60BB (Hoya)

Non‐blue‐light filtering IOL 1

  • Type of IOL: SA60AT (Alcon)

Non‐blue‐light filtering IOL 2

  • Type of IOL: MA60BM (Alcon)

Non‐blue‐light filtering IOL 3

  • Type of IOL: VA60BB (Hoya)

Outcomes

Refractive error, visual acuity, IOL tilt, IOL decentration, intraocular pressure, corneal endothelial cell loss and aqueous flare at three months postoperatively

Identification

Sponsorship source:

Funding sources: none

Declaration of interest: none for all authors

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Date study conducted: not reported

First author's name: M Aose

Institution: Ophthalmology, Dokkyo University School of Medicine, Tochigi, Japan

Email: not reported

Address: not reported

Notes

ARVO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting, participants and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting, the outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Bandyopadhyay 2016

Methods

Study design: RCT

Study grouping: parallel group, with 1 eye per participant randomised to 1 of the interventions

Exclusions after randomisation: none apparent

Losses to follow‐up: none apparent

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1 ‐ yellow

  • Number of participants: number of people (number of eyes): 32 (32)

  • Sex (number of women/number of men): 15/17

  • Age (mean ± SD): 64.12 ± 7.60 years

Blue‐light filtering IOL group 2 ‐ orange

  • Number of participants: number of people (number of eyes): 33 (33)

  • Sex (number of women/number of men): 17/16

  • Age (mean ± SD): 66.27 ± 9.11 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 33 (33)

  • Sex (number of women/number of men): 15/18

  • Age (mean ± SD): 64.48 ± 8.55 years

Inclusion criteria: people with senile cataract

Exclusion criteria: people having anomalies or guttata in the corneal endothelium; receiving any ocular treatment within 1 month prior to commencement of the study; taking any medication that can produce somnolence or who are drug addicts or alcoholics; with retinopathies or any other ocular pathology; with any other condition including psychiatric abnormalities that could alter the results; whose pupils were not dilating well with mydriatics

Comparison of study groups at baseline: no significant baseline differences

Interventions

Intervention characteristics

Blue‐light filtering IOL 1 ‐ yellow

  • Type of IOL: AcrySof SN60AT (Alcon

Blue‐light filtering IOL 2 ‐ orange

  • Type of IOL: PC440Y (Optech)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof SA60AT (Alcon)

Outcomes

BCVA and contrast sensitivity (photopic and mesopic) at one month postoperatively

intraoperative complications, and postoperative complications at one month after surgery

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: none

Country: India

Setting: tertiary care hospital in Kolkata, West Bengal, Eastern India

Comments:

Date study conducted: enrolments from 1 August 2014‐31 January 2015

Trial registration number: not provided

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Sabayaschi Bandyopadhyay

Institution: Department of Ophthalmology, R. G. Kar Medical College

Email: [email protected]

Address: Department of Ophthalmology, R. G. Kar Medical College, 1 Khudiram Bose Sarani, Kolkata 700 004, India

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in the absence of reporting, participants and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting, assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not clearly stated

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Barisic 2007

Methods

Study design: RCT

Study grouping: parallel group, with bilateral IOL implantation of same IOL type, except for six participants where a blue‐light filtering IOL (AcrySof Natural) was implanted in one eye and a non‐blue‐light IOL (AcrySof MA60BM) was implanted in the other eye.

Exclusions after randomisation: none apparent

Losses to follow‐up: none apparent

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (60)

  • Sex (number of women/number of men): 21/9

  • Age (mean): 68 ± 4.5 years (unit of error not detailed in manuscript)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (60)

  • Sex (number of women/number of men): 21/9

  • Age (mean): 67 ± 4.2 years (unit of error not detailed in manuscript)

Inclusion criteria: people having bilateral cataract surgery

Exclusion criteria: people with glaucoma, retinal, or any other severe ocular pathology

Comparison of study groups at baseline: "There were no significant differences between the two investigated groups regarding age, gender and ocular pathology."

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof Natural IOL (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof MA60BM IOL (Alcon)

Outcomes

Distance UCVA, measured as the proportion of eyes with UCVA < 0.8 decimal acuity or > 0.8 decimal acuity, after six months

Distance BCVA, measured categorically as the number of eyes with BCVA of 0.8, 0.9 or 1.0 decimal acuity, after six months

Proportion of people, reported as a dichotomous, who were overall satisfied with their visual outcome (i.e., would have the same type of IOL implanted again), after six months

Adverse events:

  • percentage of participants, in each group, requiring a Nd:YAG laser capsulotomy after six months

  • percentage of participants, in each group, that had intraoperative complications

  • rate of postoperative complications in each group after six months

Identification

Sponsorship source:

Funding source: not reported

Declaration of interest: not reported

Country: Croatia

Setting: University Department of Ophthalmology, General Hospital Sveti Duh, Zagreb, Croatia, and Eye Clinic Svjetlost, Zagreb, Croatia

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Ante Barisic

Institution: University Department of Ophthalmology, General Hospital Sveti Duh, Zagreb, Croatia

Email: not reported

Address: University Department of Ophthalmology

General Hospital Sveti Duh

Zagreb, Croatia

Notes

Population
Unit of error (SD/SEM) not detailed for age of participants at baseline

Interventions
For the intervention, the manuscript states that: "In six patients AcrySof Natural IOL was implanted in one eye and AcrySof MA60BM IOL in other eye," however no further details were reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided about masking; we assume that in absence of reporting, participants and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking; we assume that in absence of reporting, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: complete reporting for n = 60 participants is implied from the data; from the number of eyes presented in Figures 1, 2 and 3

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Behrens‐Baumann 2005

Methods

Study design: RCT

Study grouping: parallel group

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Overall

  • Number of participants: number of people (number of eyes): 40 (?)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: people with amblyopia or abnormal Ishihara test

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AF‐1 (UY) YA‐60BB (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: AF‐ I (UV) VA‐60BB (Hoya)

Outcomes

Colour recognition and contrast sensitivity (mesopic and photopic); time point not specified in the abstract

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Wolfgang Behrens‐Baumann MD

Institution: not reported

Email: not reported

Address: not reported

Notes

AAO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details.

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "open label investigation,"

Judgement comment: study is described as "open label"

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: study is described as "open label"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Bhattacharjee 2006

Methods

Study design: RCT

Study grouping: parallel group, with inter‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL).

Exclusions after randomisation: participants with intraoperative complications were excluded from the analysis; no further details were supplied.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 13 (13)

  • Sex (number of women/number of men): 7/6

  • Age (mean ± unit of error): 62.15 ± 6.68 years (unit of error not specified)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 13 (13)

  • Sex (number of women/number of men): 7/6

  • Age (mean ± unspecified unit of error): 62.15 ± 6.68 years (unit of error not specified)

Inclusion criteria: people ≥ 60 years with good general and ocular health having bilateral age‐related cataracts with a potential visual acuity of 20/40 or better, indicating cataract extraction and IOL implantation (in both eyes), and who agreed to have surgery in both eyes within a maximum interval of 60 days and were willing to complete a schedule of postoperative follow‐ups.

Exclusion criteria: people with pre‐existing systemic disease such as diabetes or hypertension, ocular disease, such as uveitis, or who failed the Farnsworth Munsell 100‐Hue test prior to surgery. To avoid the skew deviation of the results, people with an intraoperative complication such as hyphema, zonular rupture, or posterior capsule were also excluded.

Comparison of study groups at baseline: no group differences for the 26 eyes (13 participants) that were reported. However, we are unable to judge any potential group difference for participants who were excluded due to intraoperative complications.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof SA60AT (Alcon)

Outcomes

Distance BCVA, colour perception and contrast sensitivity at 18 months postoperatively

Identification

Sponsorship source:

Funding sources: Sri Kanchi Sankara Health Educational Foundation, Beltola, Guwahati, Assam, India

Declaration of interest: no author had a financial or proprietary interest in any material or method mentioned.

Country: India

Setting: Sri Sankaradeva Nethralaya Beltola, Assam, India

Comments:

Date study conducted: June‐August 2003

Trial registration number: not reported

Contacting study investigators: we emailed the study authors on 1 September 2017 for the means and standard deviations of the within‐pair differences in distance BCVA at follow‐up; no response was received. As a result, we could not incorporate these data in a meta‐analysis.

Corresponding author's name: Harsha Bhattacharjee, MS, Medical Director

Institution: Sri Sankaradeva Nethralaya Beltola, Assam, India

Email: [email protected]

Address: Harsha Bhattacharjee, MS, Medical Director SriSankaradeva Nethralaya Beltola, Guwahati 781028, Assam, India

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "On random selection basis in each patient"

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "patient‐masked, examiner‐masked"

Judgement comment: clearly states that participants and personnel were not aware of which intervention was received, but surgeon was not masked

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Judgement comment: clearly states that study was "examiner‐masked"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: appears "patients with an intra‐operative complication... were also excluded" so not intention‐to‐treat and no indication of how many participants were excluded on these grounds

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Brøndsted 2014

Methods

Study design: RCT

Study grouping: parallel group, with bilateral IOL implantation (although no further details provided)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: people with cataract and no other significant diseases

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: not reported

Non‐blue‐light filtering IOL

  • Type of IOL: not reported

Outcomes

Short wavelength chromatic pupillometry, measured using the consensual pupil reaction

Circadian rhythm, assessed by direct activity measurements (actigraphy) and by questionnaires (Pittsburgh Sleep Quality Index and Morningness Eveningness Questionnaire)

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for the review

Corresponding author's name: Adam Elias Brøndsted

Institution: University of Copenhagen

Email: not reported

Address: not reported

Notes

ARVO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as "randomised" but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Brøndsted 2015

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: the publication states that "preoperative and postoperative complications with an impact on visual acuity, including ruptured capsule, nucleus drop, and postoperative corneal oedema, led to exclusion." However, no participants developed postoperative complications leading to exclusion.

Losses to follow‐up: a total of 76 participants were enrolled from screening 267 candidates; 73 participants were randomised (n = 35 to a non‐blue‐light filtering IOL and n = 38 to a blue‐light filtering IOL) "because oneparticipant changed her mind regarding the operation and one participant dropped out after the baseline examination and another participant was excluded at the day of the operation because of posterior capsule rupture. Further, one participant found the study procedures too comprehensive and dropped out after the first control visit, producing a final number of 72 participants at the three‐week postoperative visit."

How missing data were handled: not reported

Reported power size calculation? yes

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 38 (38)

  • Sex (number of women/number of men): 16/22

  • Age (mean, (range)): 74 (65‐94) years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 35 (35)

  • Sex (number of women/number of men): 22/13

  • Age (mean, (range)): 73 (50‐88) years

Inclusion criteria: all patients who were referred for bilateral senile cataract surgery to the Department of Ophthalmology, Rigshospitalete Glostrup, Denmark and provided written informed consent

Exclusion criteria: ophthalmological disease with an expected effect on the retina, optic disc, or cornea, including advanced AMD, glaucoma, diabetic retinopathy, corneal dystrophy, ocular trauma, and recurrent uveitis; people with severe systemic disease, including diabetes, cancer of any kind, and known sleep disturbances; people with preoperative and postoperative complications with an impact on visual acuity, including ruptured capsule, nucleus drop, and postoperative corneal oedema

Comparison of study groups at baseline: there were no significant inter‐group differences at baseline. Participants were similar in terms of age, sex, distance BCVA, cataract severity and circadian type.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof SN60WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AMO ZCB00 (Abbott Medical Optics)

Outcomes

Activation of intrinsic photosensitive ganglion cells using post‐illumination pupil response (PIPR) to blue light from 10‐30 s after light exposure as a surrogate measure, before surgery, and at two days and three weeks post‐surgery.

Circadian rhythm analysis using actigraphy and 24‐h salivary melatonin measurements before, and at 3 weeks after surgery

Objective and subjective sleep quality, as determined by actigraphy and the Pittsburgh Sleep Quality Index before, and at 3 weeks postsurgery

Identification

Sponsorship source:

Funding sources: the study was funded by the Danish Association of the Blind and the Velux Foundation.

Declaration of interest: the author(s) have no proprietary or commercial interest in any materials discussed in this article.

Country: Denmark

Setting: Department of Ophthalmology, Rigshospitalete Glostrup, Denmark

Comments:

Date study conducted: not reported

Trial registration number: clinicaltrials.gov (NCT01686308)

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Adam Elias Brøndsted, MD

Institution: Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark

Email: [email protected]

Address: Henrik Ibsens Vej 2, 4.tv, 1813 Frederiksberg C, Denmark

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was performed on the day of the surgery using automated, computerized block‐randomization lists"

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "Because of the different colors of the blue‐blocking and neutral IOLs, it was not possible to keep the investigator masked to IOL type."

Judgement comment: Participants were masked but not the "investigator".

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: whether the "same physician (A.E.B)" who examined all particpants was masked or unmasked is not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: 72 of the 76 participants enrolled completed the study

Selective reporting (reporting bias)

Low risk

Judgement comment: main outcome measures are as specified in the relevant entry on clinicaltrials.gov

Other bias

Low risk

Judgement comment: no other risks of bias identified

Brøndsted 2017

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant contributing to the analyses

Exclusions after randomisation: "One participant was excluded at the day of surgery due to posterior capsule rupture" (although group allocation is not described).

Losses to follow‐up: "The first eye in 76 participants was recruited for the study. Of these, 72 participants completed the three‐week follow‐up and 67 completed the one‐year follow‐up (31 allocated to neutral IOL and 36 allocated to blue‐blocking IOL). One participant was excluded at the day of surgery due to posterior capsule rupture, one participant dropped out and one participant changed her mind regarding the surgery. Three participants declined participation in the one‐year follow‐up and two participants did not respond to the invitation letter or to telephone calls."

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 36 (36)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 31 (31)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: people with bilateral, age‐related cataract eligible for cataract surgery according to the local guidelines. Only the first eye, that is the eye first scheduled for cataract surgery, was included in the study although both eyes were scheduled for surgery.

Exclusion criteria: any eye disease with an expected effect on the retina, optic nerve or cornea including advanced AMD, glaucoma, diabetic retinopathy, corneal dystrophy, ocular trauma or recurrent uveitis. People with severe systemic disease, including diabetes, cancer of any kind and known sleep disturbances.

Comparison of study groups at baseline: not reported. Note: it is stated that "One participant was excluded at the day of surgery due to posterior capsule rupture" (although group allocation is not described).

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof SN60WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AMO ZCB00 (Abbott Medical Optics)

Outcomes

The main outcome was the intrinsic activation of photosensitive retinal ganglion cells estimated by quantitation of the postillumination pupil response to blue light based on consensual pupil response measurements at one year after surgery.

Circadian rhythm, measured by 24‐h melatonin profiles and actigraphy at one year after surgery

Self‐evaluated sleep quality, measured using the Danish version of the Pittsburgh Sleep Quality Index (PSQI) at three weeks postoperative and one year after surgery

Identification

Sponsorship source:

Funding sources: the study was funded by the Danish Association of the Blind and the Velux Foundation.

Declaration of interest: not reported

Country: Denmark

Setting: Department of Ophthalmology, Rigshospitalete Glostrup, Denmark

Comments:

Date study conducted: not reported

Trial registration number: clinicaltrials.gov (NCT01686308)

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Adam Elias Brøndsted, MD

Institution: Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark

Email: [email protected]

Address: Henrik Ibsens Vej 2, 4.tv, 1813 Frederiksberg C, Denmark

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Computerized block randomization lists"

Judgement comment: Computer generated list

Allocation concealment (selection bias)

Unclear risk

Quote: "Randomized to implantation"

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "Masking of the participants"

Judgement comment: "Participants were masked but it is unclear whether study personnel were masked."

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this patients and personnel were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "The first eye in 76 participants was recruited for the study. Of these, 72 participants completed the 3‐week follow‐up and 67 completed the 1‐year follow‐up (31 allocated to neutral IOL and 36 allocated to blue‐blocking IOL). 1 participant was excluded at the day of surgery due to posterior capsule rupture, one participant dropped out and one participant changed her mind regarding the surgery. Three participants declined participation in the 1‐year follow‐up and two participants did not respond to the invitation letter or to telephone calls."

Judgement comment: missing data < 20%

Selective reporting (reporting bias)

High risk

Judgement comment: results of the "Morningness‐eveningness questionnaire", listed as a Secondary Outcome Measure on the clinicaltrials.gov entry are not reported

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Caporossi 2007

Methods

Study design: RCT

Study grouping: parallel group, where both eyes of each participant were randomised to the same type of intervention

Exclusions after randomisation: participants with intraoperative complications, IOL tilt or decentration were excluded from the analyses; however, no participant had these complications

Losses to follow‐up: none

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1 ‐ SN60AT (Alcon)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 70.2 ± 4.1 years (unit of error not specified)

Non‐blue‐light filtering IOL group 1 ‐ Tecnis Z9000 (AMO)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 67.2 ± 4.9 years (unit of error not specified)

Blue‐light filtering IOL group 2 ‐ SN60WF (Alcon)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 72.2 ± 7.1 years (unit of error not specified)

Non‐blue‐light filtering IOL 2 ‐ Sensar AR40e (AMO)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 68.4 ± 5.1 years (unit of error not specified)

Non‐blue‐light filtering IOL 3 ‐ Sofport L161AO (Bausch & Lomb)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 71.4 ± 5.4 years (unit of error not specified

Inclusion criteria: people aged between 50 and 80 years, bilateral cataracts, potential acuity better than 0.2 logMAR units, preoperative corneal spherical aberration (Z04) values between 0.1 and 0.25μm at 5‐mm pupil diameter, and IOL power between +18.00 and +24.00 diopters (D)

Exclusion criteria: people were excluded if any of the following conditions were present: corneal astigmatism ≥ 1.00 D, surgical complications, IOL tilt and decentration estimated by retroillumination, glaucoma, amblyopia, corneal pathology, history of uveitis, diabetic retinopathy, pseudoexfoliation syndrome, macular pathology, and previous intraocular surgery. People using topical medications (apart from lubricants) and taking systemic steroids also were excluded.

Comparison of study groups at baseline: there were no statistically significant differences among the groups in terms of participant age (P > 0.05).

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: SN60AT (Alcon)

Non‐blue‐light filtering IOL 1

  • Type of IOL: Tecnis Z9000 (AMO)

Blue‐light filtering IOL 2

  • Type of IOL: SN60WF (Alcon)

Non‐blue‐light filtering IOL 2

  • Type of IOL: SensarAR40e (AMO)

Non‐blue‐light filtering IOL 3

  • Type of IOL: Sofport L161AO (Bausch & Lomb)

Outcomes

BCVA, contrast sensitivity (mesopic and photopic), corneal abberations and wavefront spherical aberration of the whole eye, at two months postoperatively

intraoperative complications and postoperative complications at two months postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: "the authors have no proprietary interest in the materials presented herein"

Country: Italy

Setting: Department of Ophthalmology and Neurosurgery at the University of Siena, Italy

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: authors contacted on 14th August 2017, Re: Table 2 – whether units of error show SD or another unit (as not specified in the paper); no response was received

Corresponding author's name: Gianluca Martone, MD

Institution: Department of Ophthalmology and Neurosurgery at the University of Siena, Italy

Email: [email protected]

Address: Gianluca Martone, MD Dipartimento di Scienze Oftalmologiche e NeurochirurgicheUniversità degli Studi di Siena, Viale Bracci 1, 53100 Siena, Italy

Notes

Data reported in this study for the SN60AT, SN60WF, Sensar AR40e, Tecnis Z900 participants (n = 100 people, n = 200 eyes) is the same as for the Caporossi 2009 paper (which reports later follow‐up time points for these participants).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: participants were masked to which IOL they received; however, there is no comment regarding other personnel, so we assume that in the absence of this information, the study personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: we assume that in absence of reporting, the outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: participants with “surgical complications, IOL tilt and decentration estimated by retroillumination” were excluded, but the paper also states that “no intraoperative or postoperative complications were recorded in the study. In particular no cases of significant IOL decentration and tilt developed during the follow‐up. Further, for the 125 participants enrolled in the study, none of the 125 patients dropped out of the study.”

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Caporossi 2009

Methods

Study design: RCT

Study grouping: parallel group, where both eyes of each participant were randomised to the same type of intervention (as per the Caporossi 2007 study)

Exclusions after randomisation: 2‐year follow‐up data from participants in the Caporossi 2007 study

Losses to follow‐up: none at 2 months postoperatively, 6 participants (12 eyes) at 1 year postoperatively and 11 participants (22 eyes) at 2 years postoperatively

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1 ‐ SN60AT (Alcon)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 70.2 ± 4.1 years (unit of error not specified)

Non‐blue‐light filtering IOL group 1 ‐ Tecnis Z9000 (AMO)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 67.2 ± 4.9 years (unit of error not specified)

Blue‐light filtering IOL group 2 ‐ SN60WF (Alcon)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 72.2 ± 7.1 years (unit of error not specified)

Non‐blue‐light filtering IOL 2 ‐ Sensar AR40e (AMO)

  • Number of participants: number of people (number of eyes): 25 (50)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): 68.4 ± 5.1 years (unit of error not specified)

Inclusion criteria: people aged between 50 and 80 years, bilateral cataracts, potential acuity > 0.2 logMAR units, preoperative corneal spherical aberration (Z04) values between 0.1 and 0.25 pm at 5 mm pupil diameter, and IOL power between + 18.00 and + 24.00 diopters (D)

Exclusion criteria: people with any of the following present: corneal astigmatism of 1.00 D or more, surgical complications, IOL tilt and decent ration estimated by retroillumination, glaucoma, amblyopia, corneal pathology, history of uveitis, diabetic retinopathy, pseudoexfoliation syndrome, macular pathology, or previous intraocular surgery. People using topical medications (apart from lubricants) or systemic steroids

Comparison of study groups at baseline: no statistically significant differences among groups in terms of age (P > 0.05) were noted.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: Acrysof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOL 1

  • Type of IOL: Tecnis Z9000 (AMO)

Blue‐light filtering IOL 2

  • Type of IOL: Acrysof IQ SN6OWF (Alcon)

Non‐blue‐light filtering IOL 2

  • Type of IOL: Sensar OptiEdge AR40e (AMO)

Outcomes

BCVA, contrast sensitivity (mesopic and photopic), pupil size, corneal abberations and wavefront spherical aberration of the whole eye, at two months, one year and two years postoperatively

Postoperative complications (Nd:YAG capsulotomies) at two years postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: the authors have no proprietary interest in the materials presented herein.

Country: Italy

Setting: Department of Ophthalmology, University of Siena, Italy

Comments:

Date study conducted: surgeries performed between March 2004‐July 2005

Trial registration number: not reported

Contacting study investigators: authors contacted on 14 August 2017 regarding distance BCVA and contrast sensitivity units of error (specifically, whether it is the SD or a different unit or error). We also asked for clarification with regard to why the longer‐term follow‐up data for individuals fitted with the Sofport L161AO lens (described in the earlier paper by Caporossi 2007, are not reported here). No response was received to the email, and as a consequence we could not incorporate these data in the meta‐analyses.

Corresponding author's name: Gianluca Martone, MD

Institution: Department of Ophthalmology, University of Siena, Italy

Email: [email protected]

Address: Gianluca Martone, MDVia Fontenuovu n.2O, 53100, Siena, Italy

Notes

Outcomes:We had already considered the rate of intraoperative complications in this group of participants in Caporossi 2007, so we did not extract the data again from this paper.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation was administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: we assume that in the absence of reporting, neither participants nor study personnel were masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: we assume that in the absence of reporting, the outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: participants with “surgical complications, IOL tilt and decentration estimated by retroillumination” were excluded, but the paper also states that “no intraoperative or postoperative complications were recorded" in the study. At two years postoperatively, 89 participants (178 eyes) out of 200 participants remained in the study; reasons for incomplete follow‐up are included (Table 2), and this is relatively equal across the four intervention groups. Although, note that the Caporossi 2007 paper, which reported baseline and two‐month follow‐up data for the same participants, included five lens types rather than four lens types (data relating to the Sofport L161AO lens are not included in this paper, without explanation).

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Cionni 2003

Methods

Study design: RCT

Study grouping: parallel group, where both eyes of each participant were randomised to the same type of intervention, but the unit of analysis was not reported

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 150 (300)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 150 (300)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural SB30AL (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Acrysof SA30AL (Alcon)

Outcomes

Visual acuity, colour perception and contrast sensitivity; time point not reported

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported.

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Robert J Cionni, MD

Institution: not reported

Email: not reported

Address: not reported

Notes

AAO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: study is described as "patient‐masked" only

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: study is described as "patient masked"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Cristobal 2005

Methods

Study design: RCT

Study grouping: parallel group, with inter‐eye comparison (i.e. 1 eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL).

Exclusions after randomisation: participants with perioperative or postoperative complications were excluded, but no details were provided about these participants.

Losses to follow‐up: people that did not attend follow up or did not use the indicated postoperative medications were excluded, but no details were provided about these participants.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 32 (32)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 32 (32)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: people requiring bilateral cataract surgery with an IOL implant

Exclusion criteria: people who didn't attend follow‐up or didn't use the indicated postoperative medications; with systemic diseases that could influence visual function; with postoperative refractive error > 3.00 D; with perioperative or postoperative complications

Comparison of study groups at baseline: no baseline information provided on the included participants

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Acrysof SA60AT (Alcon)

Outcomes

Contrast sensitivity scores with CSV 1000E (®Vistech), for 3, 6, 12 and 18 cycles/degree at 2.6 meters, in scotopic conditions without glare at eight weeks postoperatively

Colour vision errors with the Farnsworth test (25 colours) at eight weeks postoperatively

participants' subjective measures of self visual function, including colour vision and glare at eight weeks postoperatively

BCVA, in decimal scale, at eight weeks postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: JA Cristobal

Institution: Hospital Clínico Universitario Lozano Blesa, Zaragoza, España

Email: not reported

Address: not reported

Notes

Article in Spanish (translated to English for data extraction)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported, and "patients with perioperative or postoperative complications" were excluded from participation; details of those excluded on these grounds are not provided

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: no baseline information available on the included participants

Cui 2009

Methods

Study design: RCT

Study grouping: parallel group, involving the randomisation of 57 people and 61 eyes, with no further details regarding treatment allocation

Exclusions after randomisation: participants who were unable to understand or co‐operate with the contrast sensitivity examination were excluded, but no details were provided about these participants.

Losses to follow‐up: participants who were lost to follow‐up were excluded, but no details were provided about these participants

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): 20 (21)

  • Sex (number of women/number of men): 9/11

  • Age (mean ± SD): 70.2 ± 6.7 years (unit of error not specified)

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): 19 (20)

  • Sex (number of women/number of men): 9/10

  • Age (mean ± SD): 67.8 ± 7.6 years (unit of error not specified)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 18 (20)

  • Sex (number of women/number of men): 9/9

  • Age (mean ± SD): 67.3 ± 9.3 years (unit of error not specified)

Inclusion criteria: people were included who had age‐related cataract, underwent bilateral cataract surgery at the First Affiliated Hospital, Zhejiang University, ranged in age from 50–80 years, and had low degrees of spherical diopters (≤ 2.5 D) and astigmatism (≤ 1.0 D cylindrical) postoperatively.

Exclusion criteria: a history of ocular diseases, such as corneal disease, glaucoma, uveitis, and retinal detachment; a history of systemic diseases, such as diabetes and hyperthyroidism

Comparison of study groups at baseline: there was no significant difference in age, sex, laterality, or diopter (power) of the IOLs among the three groups at baseline.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: Acrysof IQ SN60WF (Alcon)

Blue‐light filtering IOL 2

  • Type of IOL: Acrysof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Tecnis Z9001 (AMO)

Outcomes

BCVA, higher‐order aberrations, contrast sensitivity pre‐operatively and at one week, one month and two months postoperatively

Intraoperative and postoperative complications at two months postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: the authors have no proprietary or commercial interest in any materials discussed in this article.

Country: China

Setting: Department of Ophthalmology, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Dinghua Lou, MD

Institution: Department of Ophthalmology, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

Email: [email protected]

Address: Department of Ophthalmology, First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Rd., Hangzhou, Zhejiang, China

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided in relation to masking

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided in relation to masking

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not clearly reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Cuthbertson 2009

Methods

Study design: RCT

Study grouping: parallel group, involving one eye per participant randomised to an intervention (being a mix of first and second eyes undergoing cataract surgery)

Exclusions after randomisation: people with complicated surgery were excluded. One participant developed endophthalmitis and was removed from the trial, being replaced (after re‐randomisation) by another individual.

Losses to follow‐up: One participant developed endophthalmitis and was removed from the trial, being replaced (after re‐randomisation) by another individual. There was one anterior capsular rim tear and one posterior capsule tear without vitreous loss. For the purposes of analysis of results, each of the six lens groups contained five participants.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Overall

  • Number of participants: number of people (number of eyes): 31 (31)

  • Sex (number of women/number of men): 18/13

  • Age (mean): 75 (range: 51‐87) years

Inclusion criteria: people were recruited from cataract preassessment clinics, and informed consent was obtained. Any person over the age of 18 able to understand English and to give informed consent was eligible for inclusion in the trial.

Exclusion criteria: exclusion criteria included coexistent ocular pathology, cylinder > 2 dioptres, complicated surgery and wheelchair‐bound patients.

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOLs

  • Type of IOL: Acrysof Natural (Alcon) or AcrySof IQ (Alc

Non‐blue‐light filtering IOLs

  • Type of IOL: Tecnis Z9000 (AMO) or Cee On Edge (AMO) or Akreos AO (Bausch & Lomb) or Akreos Adapt (Bausch & Lomb)

Outcomes

BCVA under standard photopic lighting conditions, contrast sensitivity (under mesopic (6 cd/m2) and photopic (65 cd/m2) conditions with and without glare (CST 1800 digital with Ginsberg Box, Vision Sciences Research Corporation), pupillometry, autorefraction, topography and wavefront analysis preoperatively, at two weeks and three months postoperatively

Identification

Sponsorship source:

Funding sources: no financial support received

Declaration of interest: no financial interests

Country: England

Setting: Department of Ophthalmology, Oxford Eye Hospital, West Wing, John Radcliffe Hospital

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: FM Cuthbertson

Institution: Department of Ophthalmology, Oxford Eye Hospital

Email: [email protected]

Address: Department of Ophthalmology, Oxford Eye Hospital, West Wing, John Radcliffe Hospital, Headley Way, Oxford OX3 9DUUK.

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: Assessor masked but no mention of participant masking

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The two observers carrying out the pre and postoperative assessments (FC and SD) were masked as to which lens the patient had received."

Judgement comment: clearly states that the outcome assessors were masked to the lens allocation

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not explicitly reported. Participants with complicated surgery were excluded from the analysis. "One participant developed endophthalmitis and was removed from the trial, being replaced (after re‐randomisation) by another individual. There was one anterior capsular rim tear and one posterior capsule tear without vitreous loss. For the purposes of analysis of results, each of the six lens groups contained five patients."

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other source of bias

Espindle 2005

Methods

Study design: RCT

Study grouping: parallel group, where both eyes of each participant were randomised to the same type of intervention

Exclusions after randomisation: participants who were unable to understand or co‐operate with the contrast sensitivity examination were excluded, but no details were provided about these participants.

Losses to follow‐up: of the 291 participants in the starting sample, 257 participants completed both a baseline HRQoL assessment and at least one of the two assessments following IOL implantation in the second eye and thus were eligible for the HRQoL analyses. Of the 34 ineligible participants, six failed to complete any of the three HRQoL assessments, 14 did not complete a baseline assessment, and 14 completed only a baseline assessment. 19 of the 34 ineligible participants had been implanted with the blue light–filtering IOL, while the other 15 had been implanted with the clear IOL.

How missing data were handled: the primary analysis consisted of mean change to the third assessment or early termination, using the last observation carried forward approach to impute missing observations; if a score was missing at the third assessment, the score from the second assessment was carried forward, but no scores were carried forward from the baseline assessment. Analyses were also conducted on mean change to the second and third assessments without last observation carried forward to ensure the robustness of the findings.

Reported power size calculation? yes

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 131 (262)

  • Sex (number of women/number of men): 95/36

  • Age (mean ± SD): 72.5 ± 6.71 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 126 (252)

  • Sex (number of women/number of men): 73/53

  • Age (mean ± SD): 72.0 ± 6.15 years

Inclusion criteria: people requiring bilateral extraction of age‐related cataracts with implantation of a posterior chamber IOL; aged ≥ 60 years of age, in good general and ocular health; expected to achieve at least 20/40 postoperative visual acuity, and passed both the Farnsworth D‐15 Panel Test and the Ishihara colour tests

Exclusion criteria: people with alcoholism, Alzheimer’s disease, or terminal cancer; people with other eye conditions (including colour blindness or other colour‐vision deficiencies) or taking other medications that could interfere with the results to accurately measure any impact on colour vision and other outcomes postoperatively

Comparison of study groups at baseline: as shown in Table 2, there were no treatment group differences at baseline with respect to age, ethnicity, or logMAR visual acuity lines in the first operative eye. However, there was a statistically higher percentage of women in the blue light–filtering IOL group than in the clear (non‐blue light filtering) IOL group.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof single piece (Alcon)

Outcomes

The primary treatment comparison analyses focused on the vision‐specific he 39‐item National Eye Institute Visual Functioning Questionnaire (NEI VFQ‐39) score, colour vision, and driving scales, and the generic 2‐item Short Form Health Survey (SF‐12) physical and mental component summary scales. Assessments were made at baseline before implantation in the first eye and 30‐60 days and 120‐180 days after implantation of the lens in the second eye.

Identification

Sponsorship source:

Funding sources: Supported by Alcon Laboratories, Inc.

Declaration of interest: Dr. Rajagopalan was employed at Alcon Laboratories, Fort Worth, Texas, USA, at the time this research was conducted

Country: USA

Setting: six clinical sites in the USA

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information provided for review

Corresonding author's name: Derek Espindle, MA

Institution: Mapi Values

Email: [email protected]

Address: Derek Espindle, MA, 15 Court Square, Suite 620, Boston, Massachusetts 02108, USA

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation was administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "Patients and HRQoL data collectors were masked to treatment;"

Judgement comment: clearly states that participants and personnel not aware of which treatment was received

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Patients and HRQoL data collectors were masked to treatment; however, clinical investigators were not masked to treatment because the chromophore of the blue light–filtering IOL gives it a visible yellowish tint."

Judgement comment: clearly stated that outcome assessors were masked, although investigators were not

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and equal follow‐up in both groups and no obvious reason why loss to follow‐up should be related to outcome

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

High risk

Quote: "Supported by Alcon Laboratories, Inc. Dr. Rajagopalan was employed at Alcon Laboratories, Fort Worth, Texas, USA, at the time this research was conducted."

Judgement comment: Industry funding and 1 author was an employee of the IOL manufacturer

Espíndola 2012a

Methods

Study design: RCT

Study grouping: parallel group, with two study groups (non‐blue‐light filtering IOL vs different non‐blue‐light filtering IOL, n = 25 eyes each per comparison; non‐blue‐light filtering IOL vs blue‐light filtering IOL, n = 27 eyes each per comparison)

Exclusions after randomisation: participants with incomplete follow‐up were excluded from the analyses

Losses to follow‐up: participants with incomplete follow‐up were excluded from the analyses

How missing data were handled: not reported

Reported power size calculation? yes

Participants

Baseline characteristics

Blue‐light filtering IOLs

  • Number of participants: number of people (number of eyes): 27 (27)

  • Sex (number of women/number of men): 7/20

  • Age (mean ± unit of error): 68.5 ± 3.84 years (unit of error not specified)

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): 52 (77)

  • Sex (number of women/number of men): 20/32

  • Age (mean ± unit of error): not reported

Inclusion criteria: people with visually significant bilateral cataract; people with no history of glaucoma

Exclusion criteria: people with any ocular disease, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, retinal abnormalities, surgical complications, IOL tilt, previous or current use of medications known to cause colour‐vision deficiencies, or incomplete follow‐up

Comparison of study groups at baseline: paired eye study; no group differences reported and "no eye had intraoperative complications"

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOLs

  • Type of IOL: Akreos Fit (Bausch & Lomb) or Akreos AO (Bausch & Lomb) or AcrySof SA60AT (Alcon ‐ but also described as MA60AC in the paper)

Outcomes

The primary outcome measures were contrast sensitivity (photopic and mesopic) and blue‐on‐yellow perimetry values (mean deviation and pattern standard deviation), at two years postoperatively

Safety outcomes were the rate of intraoperative complications and the proportion of participants requiring capsulotomy at two years postoperatively

Identification

Sponsorship source:

Funding sources: no specific financial support

Declaration of interest: no potential conflicts of interest for any authors

Country: Brazil

Setting: Study conducted in Ophthalmology Department of the University of São Paulo, São Paulo, Brazil

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Rodrigo F. Espíndola

Institution: Ophthalmology Department of the University of São Paulo, São Paulo, Brazil

Email: [email protected]

Address: Rodrigo F. EspíndolaPraça das Hortências, 70 ‐ Itu (SP) ‐ 13301‐689 ‐ Brazil

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Low risk

Quote: "Sequenced and sealed envelopes containing the first type of IOL (Akreos AO or Akreos Fit; SN60AT or MA60AC) were prepared before surgery. An unscrubbed observer in the operating room opened the envelopes and assigned each patient."

Judgement comment: clearly states how the intervention allocation was concealed

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "All patients and observers were masked about the IOL type implanted."

Judgement comment: clearly states that all participants and observers were masked to the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The observers who conducted the postoperative visual evaluations did not have access to the randomization code or information about the surgical procedures."

Judgement comment: clearly states that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "All patients completed 24 months of follow‐up."

Judgement comment: although the paper states "All patients completed 24 months of follow‐up", an exclusion criterion was that "Patients with surgical complications or incomplete follow‐up were excluded". Although "there were no eyes with intraoperative complications," it is unclear whether follow‐up was 100‐percent for all participants as this was an exclusion criterion.

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Falkner Radler 2008

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant contributing to the analyses

Exclusions after randomisation: none apparent

Losses to follow‐up: none

How missing data were handled: not reported; all participants were reported to complete the final study visit

Reported power size calculation? yes

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 24/6

  • Age (mean): 68 years (unit of error not specified)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 19/11

  • Age (mean): 66 years (unit of error not specified)

Inclusion criteria: diagnosed vitreoretinal pathologic features, including diabetic vitreous haemorrhage, macular hole, epiretinal membrane, or persisting macula oedema, and coexisting significant cataract; the need for combined surgery, namely pars plana vitrectomy, phaco‐emulsification, and IOL implantation; age > 50 years

Exclusion criteria: pseudophakia on the non‐study eye; the need for silicone oil tamponade; optic atrophy

Comparison of study groups at baseline: "Patients’ baseline demographic data were comparable between both IOL groups (p>0.05, t test)."

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof natural single‐piece (Alcon) or Hoya AF‐1 UY single‐/three‐piece (Polytech Ophthalmologie)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof single‐piece (Alcon) or Hoya AF‐1 UV single‐/three‐piece (Polytech Ophthalmologie)

Outcomes

Intraoperative conditions for the surgeon, the functional outcome of the surgery (as related to BCVA, contrast sensitivity, colour vision and glare effects), complication rates (intraoperative and postoperative ) and vitreo‐retinal diagnoses, at seven days, one month and three months of follow‐up

Identification

Sponsorship source:

Funding sources: none

Declaration of interest: none for all authors

Country: Austria

Setting: the Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery, Department of Ophthalmology, Rudolf Foundation Clinic, Vienna, Austria

Comments:

Date study conducted: 14 October 2004‐March 2006

Trial registration number: ClinicalTrials.gov NCT00537992

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Christiane I. Falkner‐Radler

Institution: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Lasersurgery Department of Ophthalmology, Rudolf Foundation Clinic

Email: christiane.falkner‐[email protected]

Address: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology Rudolf Foundation Clinic, Juchgasse 25, A‐1030, Vienna, Austria

Notes

Interventions
In all cases, phacoemulsification (scleral tunnel or clear corneal incision) and IOL implantation were followed by a vitreoretinal procedure.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Quote: "The patients included were assigned randomly to receive 30 clear UV‐filter IOLs (clear IOL group) and 30 yellow‐ blue light–filter IOLs (yellow IOL group)."

Judgement comment: not reported how allocation was administered. Assignment is described as "random" but without further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information on masking; we assume that in the absence of reporting, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Quote: "A masked statistical analysis for the questionnaire responses and the other main outcome parameters, namely mean differences between three‐month postoperative and baseline values for distance visual acuity (DVA), near visual acuity (NVA), contrast sensitivity, color vision, and glare effect for each IOL group was performed."

Judgement comment: no information was provided in relation to the masking of outcome assessors (only the statistician); we assume that in the absence of reporting, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "No patient was lost to follow‐up, and all patients completed the three‐month postoperative follow‐up examination."

Judgement comment: no participants were lost to follow‐up

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to a protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Hahsler 2004

Methods

Study design: RCT

Study grouping: parallel group study, with no further details relating to the allocation of the interventions

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 9 (?)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 10 (?)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: SN60 (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: SA60 (Alcon)

Outcomes

Preoperative and postoperative findings were obtained regarding colour discrimination (using the Farnsowrth panel D‐15 test) and contrast perception (Pelli‐Robson contrast / sensitivity test); the time point for follow‐up was not reported.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Austria

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information provided for review

First author's name: B Hahsler

Institution: not reported

Email: not reported

Address: not reported

Notes

Conference abstract, in German

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information to judge other sources of bias

Hahsler 2005

Methods

Study design: RCT

Study grouping: parallel group, with inter‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): 20 (20)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): 20 (20)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: HOYA‐YA (Hoya) or SN60 (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: HOYA‐VA (Hoya) or SA60 (Alcon)

Outcomes

Functional acuity contrast test and contrast sensitivity; follow‐up period not reported

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Austria

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors contacted for more information about abstract; no additional information provided for review

First author's name: B Hahsler

Institution: not reported

Email: not reported

Address: not reported

Notes

Conference abstract, in German

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information in abstract to assess other potential sources of bias

Hayashi 2006

Methods

Study design: RCT

Study grouping: parallel group, with bilateral implantation of the same intervention in both eyes, and data averaged between eyes for analyses

Exclusions after randomisation: one participant was excluded due to an epi‐retinal membrane (the group assignment was not reported)

Losses to follow‐up: of the 80 people enrolled, six were excluded from the analysis; four did not appear for a follow‐up examination because of scheduling conflicts, one refused the examination, and one had a clinically significant epiretinal membrane at the macula. Thus, 74 participants (92.5%) completed the examinations and remained in the analysis.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 38 (?)

  • Sex (number of women/number of men): 26/12

  • Age (mean ± SD): 71.1 ± 6.7 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 36 (?)

  • Sex (number of women/number of men): 24/12

  • Age (mean ± SD): 70.7 ± 6.2 years

Inclusion criteria: admission for bilateral cataract surgery

Exclusion criteria: pathology of the cornea, retina or optic nerve; a history of ocular surgery or inflammation; a pupillary diameter < 6.0 mm after mydriasis; eyes scheduled for extracapsular cataract extraction; eyes of patients with diabetes; patients who anticipated any difficulty in follow‐up.

Comparison of study groups at baseline: "No statistically significant difference was found between the groups (at baseline) regarding age, the ratio of men to women, manifest spherical equivalent, keratometric cylinder or pupillary diameter."

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: YA60BB (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: VA60BB (Hoya)

Outcomes

Visual acuity, contrast visual acuity with and without a glare source under photopic (100 cd/m2) and mesopic (slightly higher luminance than typically used ‐ 5 cd/m2) conditions at two weeks and three months after surgery using the contrast sensitivity accurate tester

The incidence of participants who noted cyanopsia at three months after surgery

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: "The authors have no proprietary interest in any of the materials described in this article"

Country: Japan

Setting: Hayashi Eye Hospital, 4‐7‐13 Hakataekimae, Hakata‐ Ku, Fukuoka 812, Japan

Comments:

Date study conducted: 3 November 2004‐20 April 2005

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for the review

Corresponding author's name: Ken Hayashi

Institution: Hayashi Eye Hospital

Email: hayaski‐[email protected]

Address: Hayashi Eye Hospital, 4‐7‐13 Hakataekimae, Hakata‐ Ku, Fukuoka 812, Japan

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The clinical research coordinator generated a code using a random number table."

Judgement comment: the randomisation sequence was generated using a random number table by the research co‐ordinator.

Allocation concealment (selection bias)

Unclear risk

Judgement comment: method of allocation concealment not specified

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "Patients and examiners were masked to the randomisation."

Judgement comment: clearly stated that participants and personnel not aware of which treatment received

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Patients and examiners were masked to the randomisation. The surgeon, who was also the data analyst, did not participate in any of the examinations or in the data collection."

Judgement comment: clearly stated that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Of the 80 patients enrolled, six were excluded from the analysis; four did not appear for a follow up examination because of scheduling conflicts, one refused the examination, and one had a clinically significant epiretinal membrane in the macula. Thus, 74 patients (92.5%) completed the examinations and remained in the analysis."

Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and relatively equal follow‐up in both groups and no obvious reason why loss to follow‐up should be related to outcome

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other source of bias

Hyunseok 2007

Methods

Study design: RCT

Study grouping: parallel group, involving 48 eyes from 42 individuals

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): ? (26)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): ? (22)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Tecnis ZA9003 (AMO)

Outcomes

Wavefront analysis by iTrace (Tracey technologies), and contrast sensitivity test at three months post‐surgery

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors contacted for more information about abstract; no additional information provided for review.

First author's name: Ahn Hyunseok MD

Institution: not reported

Email: not reported

Address: not reported

Notes

AAO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient detail in abstract to judge whether other sources of bias are present

Kara Junior 2011

Methods

Study design: RCT

Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: participants with incomplete follow‐up were not included in the analyses.

Losses to follow‐up: during the five‐year study period, five participants were lost to follow‐up; therefore, 25 participants were considered in the analyses

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30), with 25 (25) completed

  • Sex (number of women/number of men): 10/15

  • Age (mean ± SD): 59.9 ± 7.0 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30), with 25 (25) completed

  • Sex (number of women/number of men): 10/15

  • Age (mean ± SD): 59.9 ± 7.0 years

Inclusion criteria: people with visually significant bilateral cataract and no history of colour vision deficiency were eligible for inclusion in the study.

Exclusion criteria: ocular disease such as corneal opacity or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities; surgical complications; IOL tilt; previous or current use of medications known to cause colour‐vision deficiencies; incomplete follow‐up

Comparison of study groups at baseline: paired‐eye trial, however participants who had surgical complications were excluded, and no details were provided about whether there were exclusions due to intraoperative complications.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Acrysof SA60AT (Alcon)

Outcomes

The primary outcome measures were contrast sensitivity, colour vision and macular findings at five years after surgery.

Identification

Sponsorship source:

Funding sources: no funding sources listed

Declaration of interest: "No author has a financial or proprietary interest in any material or method mentioned."

Country: Brazil

Setting: Ophthalmology Department, University of Sao Paulo, Sao Paulo, Brazil

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors contacted not contacted; no additional information used for review

Corresponding author's name: Marcony R. Santhiago, MD

Institution: Cole Eye Institute, Cleveland Clinic

Email: [email protected]

Address: Cole Eye Institute Cleveland Clinic

1700 East 13th Street Apartment 15W, Cleveland, Ohio 44114, USA

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Judgement comment: described as “double‐masked” with no information on who was masked

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Judgement comment: described as “double‐masked” with no information on who was masked

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up), equal follow‐up in both groups (as paired‐eye study) and no obvious reason why loss to follow‐up should be related to outcome

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other source of bias

Kara Júnior 2006

Methods

Study design: RCT

Study grouping: parallel group, with inter‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: 46 patients had cataract surgery; 27 patients met the prespecified inclusion criteria

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 27 (27)

  • Sex (number of women/number of men): 17/10

  • Age (mean): 68.5 years (unit of error not specified)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 27 (27)

  • Sex (number of women/number of men): 17/10

  • Age (mean): 68.5 years (unit of error not specified)

Inclusion criteria: 46 patients had cataract surgery under similar preoperative conditions using the same phacoemulsification technique with a Legacy 20000 machine and NeoSoniX system (Alcon Laboratories, Inc.) and were randomised. 27 patients met the following inclusion criteria: visual acuity better than 20/40 in both eyes at least 1 year after surgery, stable intraocular pressures (IOP) throughout the 1‐year interval, and no signs or symptoms of glaucoma.

Exclusion criteria: not reported

Comparison of study groups at baseline: paired‐eye study; no significant inter‐group differences. Participants potentially excluded due to the nature of the inclusion criteria, and details about such participants are not included.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural SN60AT IOL (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof MA30AC IOL (Alcon)

Outcomes

Blue‐yellow perimetry values at one year of follow‐up

Identification

Sponsorship source:

Funding sources: not reported.

Declaration of interest: no author had a financial or proprietary interest in any materials or methods mentioned.

Country: Brazil

Setting: cataract and glaucoma clinics of a medical school associated with a public hospital in Brazil

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for this review

Corresponding author's name: Juliana Lopes Jardim, MD

Institution: Hospital das Clinicas de Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

Email: Not reported

Address: Juliana Lopes Jardim, MDAvenida Dr.Ene ́as de Carvalho Aguiar, 255, CEP: 05403‐000, São Paulo‐SP, Brazil

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The observers who conducted the postoperative visual evaluations did not have access to the randomization code or information about the surgical procedures."

Judgement comment: clearly stated that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

High risk

Judgement comment: 46 participants randomised, but only 27 included in analyses at one year

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Kennis 2004

Methods

Study design: RCT

Study grouping: parallel group, involving 71 people and 98 eyes (but with no further details)

Exclusions after randomisation: participants with intraoperative or postoperative complications and posterior capsule opacification were excluded, but no information provided in relation to whether participants were excluded on these grounds.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 22 (32)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 71.8 ± 7.0 years

Non‐blue‐light filtering IOL 1

  • Number of participants: number of people (number of eyes): 23 (33)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 74.9 ± 5.2 years

Non‐blue‐light filtering IOL 2

  • Number of participants: number of people (number of eyes): 26 (33)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 74.7 ± 5.7 years

Inclusion criteria: people from 55‐85 years of age who had clinically significant cataract

Exclusion criteria: people with ocular pathology other than cataract, neurologic or other disease known to affect contrast sensitivity (e.g. high hyperopia (> +6.0 D), high myopia (> −6.0 D), keratometric cylinder greater than 1.5 D). people with intraoperative or postoperative complications and posterior capsule opacification.

Comparison of study groups at baseline: there were no statistically significant differences between groups, with respect to age, mean preoperative refractive error and best‐corrected spectacle acuity, at baseline. However, participants with intraoperative of postoperative complications and posterior capsule opacification were excluded.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySoft Natural SN60AT IOL (Alcon)

Non‐blue‐light filtering IOL 1

  • Type of IOL: Tecnis Z9000 IOL (Pfizer)

Non‐blue‐light filtering IOL 2

  • Type of IOL: Sensar AR40e Opti‐Edge IOL (AMO)

Outcomes

BCVA, pupil size and contrast sensitivity under mesopic and photopic conditions (with and without glare), at six months of follow‐up

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Belgium or Switzerland (unclear which)

Setting: eye hospital

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: we attempted to contact the study authors emailed on 1 September 2017 for information relating to the intra‐class correlation coefficient for the within‐person clustering of BCVA; we could not identify a contact email address for any of the authors, as this was not provided on this paper or identifiable from an extensive internet search. As a result we could not include these data in any meta‐analyses.

Corresponding author's name: H. Kennis

Institution: Department of Ophthalmology, University Hospital, Leuven

Email: not reported

Corresponding author's address:

H. Kennis

Dienst Oogziekten UZ Leuven Kapucijnenvoer 33B‐3000 Leuven

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not explicitly reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Kim 2011a

Methods

Study design: RCT

Study grouping: parallel group, involving 52 people and 68 eyes (participants received a mixture of unilateral IOL implantation and bilateral IOL implantation)

Exclusions after randomisation: participants with poor co‐operation, complicated cataracts and any negative events resulting from cataract surgery were excluded from the study; no details about these participants were provided.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): not reported (19)

  • Sex (number of women/number of men): eyes 8/11 but some bilateral

  • Age (mean ± SD): 62.1 ± 12.2 years

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): not reported (26)

  • Sex (number of women/number of men): eyes 16/10 but some bilateral

  • Age (mean ± SD): 65.0 ± 11.0 years

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): not reported (23)

  • Sex (number of women/number of men): eyes 11/12 but some bilateral

  • Age (mean ± SD): 61.3 ± 10.6 years

Inclusion criteria: people who underwent cataract surgery and IOL implantation with otherwise normal eye findings

Exclusion criteria: people with diabetes mellitus, poor co‐operation, glaucoma (diagnosed by intraocular pressure, visual field exam, optic nerve morphology, and retinal nerve fibre layer findings), complicated cataracts and any negative events resulting from cataract surgery

Comparison of study groups at baseline: there were no significant differences among the three IOL groups with respect to visual acuity and spherical equivalence in the preoperative and postoperative phases.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: Acrysof IQ SN60WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: OII Biovue3 (BioVue)

Blue‐light filtering IOL 2

  • Type of IOL: YA60BBR (Hoya)

Outcomes

Frequency doubling technique ‐ Humphrey matrix pattern standard deviation and mean deviation at two months of follow‐up

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no potential conflict of interest relevant to this article was reported

Country: Korea

Setting: Department of Ophthalmology and Visual Science, The Catholic University of Korea College of Medicine, Seoul, Korea

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Choun‐Ki Joo, MD, PhD

Institution: Department of Ophthalmology and Visual Science, The Catholic University of Korea College of Medicine, Seoul, Korea

Email: [email protected]

Corresponding author's address: Choun‐Ki Joo

Department of Ophthalmology and Visual ScienceSeoul St. Mary’s Hospital 505 Banpo‐dong, Seocho‐gu, Seoul 137‐040, Korea

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not explicitly reported. "Any negative events resulting from cataract surgery were excluded from the study," so it was not an intention‐to‐treat analysis.

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Kim 2011b

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: not reported

Losses to follow‐up: 11 eyes were excluded because participants refused to receive SD‐OCT imaging or receive follow‐up examinations.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants (number of eyes): 25 (25) enrolled, 23 (23) completed

  • Sex (number of women/number of men): 19/4 completed

  • Age (mean ± SD): 65.13 ± 6.20 years

Non‐blue‐light filtering IOL group

  • Number of participants (number of eyes): 25 (25) enrolled, 16 (16) completed

  • Sex (number of women/number of men): 10/6 completed

  • Age (mean ± SD): 66.56 ± 12.30 years

Inclusion criteria: people who were undergoing phacoemulsification due to simple cataracts at the Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine, between February and September 2009.

Exclusion criteria: conditions affecting retinal nerve fibre layer (RNFL) thickness measurements, such as diabetic retinopathy, glaucoma, degenerative or exudative retinopathy, optic nerve drusen, peripapillary atrophy and tilted disc syndrome; history of previous ocular surgery; vitreous opacity

Comparison of study groups at baseline: "The participant characteristics are summarized in Table 1. There was no statistically significant difference between the two groups with respect to preoperative demographic findings."

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof IQ, SN60WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Tecnis Z9003 (AMO)

Outcomes

Peripapillary retinal nerve fibre layer thickness, measured using a Cirrus SD‐OCT, before and eight weeks after cataract surgery

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: "The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this paper."

Country: Korea

Setting: Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine

Comments:

Date study conducted: February 2009‐September 2009

Trial registration number: not reported

Contacting study investigators: study authors contacted on 20 July 2016 with regard to the content of Tables 1‐10 (which were not provided in the main text or as supplementary material). Tables provided by Dr Kim via email (20 July 2016); Dr Kim was contacted again by email on 1 August 2016 regarding Table 2, which should report BCVA data, but does not (we asked whether it was possible to obtain these data, but no response was received).

Corresponding author's name: Chan Yun Kim, MD, PhD

Institution: Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine

Email: [email protected]

Corresponding author's address:

Institute of Vision Research, Department of Ophthalmology Yonsei University College of Medicine, 134 Shinchon‐dong, Seodaemun‐gu, Seoul, 120–752, Korea

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information on masking. In the absence of reporting, assume patients and personnel were not masked

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. In the absence of reporting, assume outcome assessors were not masked

Incomplete outcome data (attrition bias)
All outcomes

High risk

Judgement comment: missing data for 11/50 participants (22%) and unequal follow‐up between groups (n=23 eyes in blue‐light filtering IOL group, n=16 in clear IOL group)

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other source of bias

Kuchenbecker 2004

Methods

Study design: RCT

Study grouping: parallel group, involving 15 participants (number of eyes not reported)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: Non‐amblyopic patients between 60 and 80 years, with "inconspicuous" colour recognition (Ishihara)

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: YA‐60BB (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: VA‐60BB (Hoya)

Outcomes

Visual acuity and contrast sensitivity at six weeks postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Germany

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors contacted to obtain further details about the abstract; no additional information provided for review

First author's name: J Kuchenbecker

Institution: Universitäts‐Augenklinik Magdeburg

Email: not reported

Corresponding author's address: not reported

Notes

Conference abstract, in German

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: study is described as open label

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: study is described as open label

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information to judge other sources of bias

Leibovitch 2006

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: one of the SN60 (blue‐light filtering) IOL participants was excluded early in the study as he refused to be operated on his other eye.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 9 (9)

  • Sex (number of women/number of men): 6/3

  • Age (mean ± SD): 74 ± 6 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 10 (10)

  • Sex (number of women/number of men): 4/6

  • Age (mean ± SD): 74 ± 6 years

Inclusion criteria: people with age‐related cataracts requiring extraction, but an otherwise normal ocular examination.

Exclusion criteria: people with other ocular pathologies, high hyperopia or myopia (6.00 D), or neurological diseases and patients using medications with a possible influence on contrast sensitivity or colour vision.

Comparison of study groups at baseline: no significant differences, other than a difference in distribution by sex. A total of 10 participants were randomised to each group but one was dropped from the SN60 group (as they refused to be operated on the other eye).

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural ‐ SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof single‐piece ‐ SA60AT (Alcon)

Outcomes

Distance BCVA (measured using a Snellen chart), contrast sensitivity (Pelli–Robson contrast sensitivity chart) and colour perception (Farnsworth–Munsell D‐15 panel test) at one, three and six months postoperatively

The postoperative change in distance BCVA, considered as a dichotomous outcome, was interpreted from the reporting of the study results, "Preoperative BCVA in both groups ranged between 20/30 and 20/200. Postoperative BCVA after six months in the SN60 group was 20/20 or better in all eyes, except 1 (11%), which had a BCVA of 20/30. Postoperative BCVA in the SA60 group was 20/20 or better in all eyes."

Intraoperative complications and postoperative complications at six months of follow‐up

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Australia

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Igal Leibovitch

Institution: Department of Ophthalmology and Visual Sciences, Royal Adelaide Hospital

Email: [email protected]

Corresponding author's address:

Dr Dinesh Selva

Department of Ophthalmology and Visual Sciences

Royal Adelaide Hospital

North Terrace Adelaide 5000 South Australia, Australia

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Low risk

Quote: "The patients were randomised to receive one of the two lenses by drawing a blank envelope for each patient out of a box of 20 envelopes. A note in each envelope stated whether an SA60 or SN60 lens would be implanted."

Judgement comment: opaque envelopes used for allocation

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "All patients were operated by a single surgeon (GP) and were unaware of the type of IOL implanted."

Judgement comment: Participants are reported to be masked, but there is no mention of whether personnel were masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: missing data is not explicitly described, but there appears to be 100% participant retention at six months

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Marshall 2005

Methods

Study design: RCT

Study grouping: parallel group, where both eyes were implanted with the same type of IOL and both eyes were used in the analyses (considered as independent samples)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: all eyes that received a test or control IOL and had at least one postoperative examination were included in the postoperative analyses.

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 150 (300)

  • Sex (number of women/number of men): 106/44

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 147 (294)

  • Sex (number of women/number of men): 89/58

  • Age (mean ± unit of error): not reported

Inclusion criteria: people had to be healthy adults older than 60 years who had bilateral age‐related cataracts. people had to be willing and able to wait at least 30 days (but no more than 60 days) between cataract extraction procedures and had to successfully pass the Ishihara colour test and Farnsworth‐Munsell D‐15 colour perception test preoperatively.

Exclusion criteria: people with retinal abnormalities, glaucoma, diabetic retinopathy, and previous or current use of medications known to cause colour‐vision deficiencies.

Comparison of study groups at baseline: there were no statistically significant differences between the test and control groups in terms of age, sex, or race (Table 1).

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural IOL ‐ model SB30AL (Alcon) (the current marketed version of this lens is the SN60AT)

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof single‐piece IOL ‐ model SA30AL (Alcon)

Outcomes

People were examined 1‐2 days, 7‐14 days, 30‐60 days, 120‐180 days, and 330‐420 days after the first procedure. Screening for IOL implantation in the fellow eye was performed at the 30‐ to 60‐day postoperative examination.

Distance BCVA was determined at all postoperative evaluations using the standard Snellen chart.

Contrast sensitivity was evaluated at the 30‐ to 60‐day and at the 120‐ to 180‐day postoperative examinations using the CSV‐ 1000E contrast sensitivity unit (Vector Vision) calibrated to assure 85 cd/m2 luminance, under photopic and mesopic conditions.

Colour perception was measured at the 30‐ to 60‐day and at the 120‐ to 180‐day postoperative examinations, using the Farnsworth‐Munsell D‐15 colour perception test.

Clinical observations of the operative eyes and the IOLs were recorded at each postoperative examination. The occurrence of hyphema, hypopyon, pupillary block, cystoid macular edema, infection or endophthalmitis, retinal detachment, and secondary surgical intervention was noted, as was the presence of IOL tilt, decentration, or dislocation. At all visits through 120 to 180 days, posterior capsule opacification was graded subjectively by slitlamp biomicroscopy as none, clinically nonsignificant, clinically significant, or clinically significant requiring neodymium: YAG (Nd:YAG) laser posterior capsulotomy, using pre‐established criteria.

Identification

Sponsorship source:

Funding sources: sponsored by Alcon Laboratories, Inc.

Declaration of interest: Drs. Cionni, Lehmann, and Maxwell are consultants to Alcon. No author has a financial or proprietary interest in the materials and methods mentioned

Country: USA

Setting: multicentre USA clinical trial

Comments:

Date study conducted: September 2000‐December 2001

Trial registration number: not reported

Contacting study investigators: study authors contacted on 1 September 2017 for details relating to the intra‐class correlation for the within‐person clustering, for the outcome measures of: BCVA, proportion of people with cystoid macular oedema at six months, intraoperative complications, and postoperative complications; no response was received after more than one month.

First author's name: John Marshall, PhD

Institution: Department of Ophthalmology GKT, The Rayne Institute, St. Thomas’ Hospital, London

Email: [email protected]

Corresponding author's address:

John Marshall

Department of Ophthalmology GKT

The Rayne Institute, St. Thomas’ Hospital

London SE1 7EH, England

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: study described as 'patient‐masked' only, and thus personnel were not masked

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: study described as 'patient‐masked' only

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: although 150 participants implanted with natural IOL and 147 with control (bilateral) only those eyes that had at least 1 postoperative examination were included in the analyses which dropped the numbers to 135 and 127 for BCVA and 109 and 102 for colour.

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

High risk

Quote: "Philadelphia, Pennsylvania, USA, June 2002. Sponsored by Alcon Laboratories, Inc. Drs. Cionni, Lehmann, and Maxwell are consultants to Alcon. No author has a financial interest."

Judgement comment: study was sponsored by Alcon Laboratories, and Drs Cionni, Lehmann and Maxwell were consultants to Alcon

Mester 2008a

Methods

Study design: RCT

Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL).

Exclusions after randomisation: 51 patients were screened and enrolled in the study. Four participants were not treated as specified in the study protocol and were excluded. Thus, 47 participants were randomised to treatment

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 47 (47)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): 47 (47)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: Bilateral cataract for which phacoemulsification and posterior IOL implantation were planned in both eyes. No prior ophthalmic surgical procedures. Age from 50‐80 years, inclusive. Bilateral potential visual acuity of 0.5 (20/40 Snellen) or better as estimated by the surgeon. No known colour‐vision deficiency. Normal colour‐vision test results on Ishihara plates. Surgery in both eyes performed by same surgeon within six weeks. Suitable for study participation according to the judgment of the clinical investigator

Exclusion criteria: congenital ocular abnormalities. Inadequate visualisation of the fundus. IOL power calculation < +10.0 diopters (D) or > +30.00 D. Astigmatism > 2.5 D. intraoperative complications (e.g. capsule rupture, bleeding). Participation in another study at the same time or 14 days before enrolment in the study. People with a history of uveitis and current intraocular inflammation, uncontrollable glaucoma, proliferative diabetic retinopathy, or retinal detachment

Comparison of study groups at baseline: the preoperative parameters for screened and enrolled participants were similar for the two IOL types, with no statistically significant differences in age; sex; UCVA; BCVA; IOP; corneal topography; photopic, mesopic, or scotopic pupil diameter; axial length; or endothelial cell density. It should be noted that participants with intraoperative complications were excluded, and no data were provided in relation to these potential exclusions, although the authors did state that "no serious ocular adverse events occurred during the study,” and "there were no pathologic findings on fundus examination in any eye at any follow‐up visit."

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AF‐1 UY (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: AF1 UV (Hoya)

Outcomes

Uncorrected and BCVA, pupil size, contrast vision (Early Treatment Diabetic Retinopathy Study (ETDRS) chart), functional acuity contrast test (photopic, mesopic, mesopic with glare), and colour discrimination (Farnsworth‐Munsell 100‐hue test, photopic and mesopic) at six and 12 months postoperatively

Identification

Sponsorship source:

Funding sources: supported by Hoya, Frankfurt, Germany.

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned

Country: Germany

Setting: five clinical ophthalmology centres in Germany

Comments:

Date study conducted: March 2005‐May 2007

Trial registration number: not reported

Contacting study investigators: study authors contacted on 1 September 2017, regarding:

  • the means and standard deviations of the within‐pair differences for visual acuity, contrast sensitivity, presence of any AMD and proportion of people with a change at the macula, at follow‐up;

  • P‐values from the repeated measures ANOVA or paired samples t‐test, for each of the outcomes detailed above;

  • information about the order effects: in the ANOVA model, was there a significant interaction between the order of implantation of different lens types and the type of lens (i.e. did yellow lens produce better/worse results if it was implanted first?).

No response was received from the authors after more than one month, and as a result we could not incorporate these data in our meta‐analyses.

First author's name: Ulrich Mester, MD

Institution: Department of Ophthalmology Bundesknappschaft’s Hospital

Email: sek‐[email protected]

Corresponding author's address:

Ulrich Mester

Department of Ophthalmology

Bundesknappschaft’s Hospital

An der Klinik 10, G‐66280 Sulzbach Germany

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated.

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provide on masking. We assume that in absence of reporting on this patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this outcome, assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "Fifty‐one patients were screened and enrolled in the study. Four patients were not treated as specified in the study protocol and were excluded. Thus, 47 patients were randomised to treatment arm 1‐1 (operation sequence: yellow IOL, clear"

Judgement comment: missing data < 20%, intra‐individual comparative study, however no information is provided on four participants treated off protocol and excluded from the analysis.

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry.

Other bias

High risk

Quote: "Supported by Hoya, Frankfurt, Germany."

Judgement comment: the study was funded by the IOL manufacturer.

Monnet 2009

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: Two IOLs in Group 3 (blue‐light filtering IOL group) were placed with one haptic in the capsular bag and one haptic outside the capsular bag; these two participants were also excluded from the final statistical analyses.

Losses to follow‐up: one participant in Group 2 (one of the two non‐blue‐light filtering IOL groups) was lost to follow‐up and was not included in the final statistical analyses.

How missing data were handled: it appears that missing data were excluded from the analysis.

Reported power size calculation? yes

Participants

Baseline characteristics

Blue‐light filtering IOL (Group 3)

  • Number of participants: number of people (number of eyes): 19 (19)

  • Sex (number of women/number of men): unclear

  • Age (mean): 72.9 years (unit of error not specified)

Non‐blue‐light filtering IOL1 ‐ MA60AC (Group 1)

  • Number of participants: number of people (number of eyes): 20 (20)

  • Sex (number of women/number of men): 8/12

  • Age (mean): 72.8 years (unit of error not specified)

Non‐blue‐light filtering IOL2 ‐ SA60AT (Group 2)

  • Number of participants: number of people (number of eyes): 20 (20)

  • Sex (number of women/number of men): 11/9

  • Age (mean): 72.6 years (unit of error not specified)

Inclusion criteria: people ≥ 60 years, of either sex, of any race, and scheduled for cataract surgery; in good general and ocular health, willing to attend all postoperative visits, and expected to achieve postoperative visual acuities of 20/40 or better

Exclusion criteria: people with a history of uveitis, uncontrolled diabetes, diabetic retinopathy, Sjogren syndrome, trauma to the operative eye, use of anti‐inflammatory medications for any reason, use of topical prostaglandin analogues for ocular hypertension or glaucoma, bleeding tendencies, congenital ocular abnormality, or a nonfunctioning fellow eye. people with intraoperative complications including capsule tears, significant anterior chamber hyphema, zonule rupture, or out‐of‐the‐bag IOL implantation. people at risk for intraoperative complications by virtue of pseudoexfoliation syndrome or poor pupil dilation (6.0 mm). people having multiple planned procedures (i.e. cataract and trabeculectomy or corneal transplantation), except those having concurrent relaxing keratotomy for astigmatism correction.

Comparison of study groups at baseline: no statistically significant differences between groups in any parameter at baseline, but no data reported for those participants who appear to be excluded from the analyses (n = 1 participant from Group 2, and n = 2 participants from Group 3, but all of Group 2 were included in the demographic data).

Interventions

Intervention characteristics

Blue‐light filtering IOL (Group 3)

  • Type of IOL: AcrySof SN60AT (Alcon)

Non‐blue‐light filtering IOL1 ‐ MA60AC (Group 1)

  • Type of IOL: Acrysof MA60AC (Alcon)

Non‐blue‐light filtering IOL2 ‐ SA60AT (Group 2)

  • Type of IOL: Acrysof 60AT (Alcon)

Outcomes

Postoperative evaluations were performed at one week, one month and three months. All visits included assessment of distance BCVA after manifest refraction, cells, flare, and adverse events.

The primary objective of the study was to compare postoperative inflammation (presence of anterior chamber cells and flare) between the three IOL models. Anterior chamber cells were initially graded on a 5‐point scale (0‐4); however, because all eyes were graded 0 or 1, except for 1 eye that was graded 2, values were dichotomised into 2 categories: (1) cell or (2) no cell.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned

Country: France

Setting: Service d’Ophtalmologie, Universite ́Paris Descartes Hospital Cochin, Paris, France

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Antoine P. Brezin, MD, PhD

Institution: Universite ́ Paris Descartes, Assistance Publique Hopitaux de Paris, Hopital Cochin, Service d’Ophtalmologie

Email: [email protected]

Corresonding author's address:

Antoine P. Brezin

Universite ́ Paris Descartes, Assistance Publique Hopitaux de ParisHopital Cochin, Service d’Ophtalmologie

27 rue du Faubourg Saint‐Jacques 75014 Paris, France

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were randomly assigned in a 1:1:1 ratio to receive one of the IOL models according to a randomization list."

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "single‐center unmasked 3‐month study"

Judgement comment: study is described as "unmasked"

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Quote: "single‐center unmasked 3‐month study"

Judgement comment: study is described as "unmasked"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: missing data < 20% (i.e. more than 80% follow‐up) and equal follow‐up in the intervention groups

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Neumaier‐Ammerer 2010

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: not reported

Losses to follow‐up: of the 80 participants (80 eyes) enrolled, 76 (95%) completed the study. Four participants (5%) did not attend the final follow‐up visit.

How missing data were handled: it appears that missing data were excluded from the analysis

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): 19 (19)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): 20(20)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): 18 (18)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): 19 (19)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: people with no history of ocular surgery or ocular pathology, such as corneal disorders, uveitis, disorders of the vitreous body or retina, glaucoma, or amblyopia

Exclusion criteria: people with known colour deficiencies or problems concentrating

Comparison of study groups at baseline: there were no statistically significant differences between IOL groups in pre‐operative age, cataract stage, visual acuity, contrast sensitivity, or colour perception. However, not all of the baseline data were reported, as it excluded four participants who did not complete the study.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: AF‐1 UY (Hoya)

Non‐blue‐light filtering IOL 1

  • Type of IOL: AF‐1 UV (Hoya

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof SN60AT (Alcon)

Non‐blue‐light filtering IOL 2

  • Type of IOL: AcrySof SA60AT (Alcon)

Outcomes

People were examined postoperatively at one week and eight weeks. Every visit included anterior and posterior segment evaluation, intraocular pressure, corrected distance visual acuity and corrected near visual acuity.

Contrast sensitivity was measured with Pelli‐Robson charts and the 1000E contrast sensitivity unit (CSV‐1000E, Vector‐Vision) with a constant test luminance level of 85 candelas/ m2. Contrast sensitivity with glare was assessed using the halogen glare test on the contrast sensitivity unit.

Corrected distance visual acuity and the Pelli‐Robson test were evaluated at three light intensities (1000 lux, 100 lux, and 10 lux) to simulate day‐light and twilight.

Colour discrimination was tested with the Roth 28 Hue Test.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned

Country: Austria

Setting: Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser‐Surgery, Department of Ophthalmology, Rudolf Foundation Clinic, Vienna, Austria

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Beatrix Neumaier‐Ammerer, MD

Institution: Department of Ophthalmology, Rudolf Foundation Hospital, Ludwig Boltzmann Institute for Retinologie and Biomicroscopic Laser surgery

Email: beatrix.neumaier‐[email protected]

Corresponding author's address:

Beatrix Neumaier‐Ammerer

Department of Ophthalmology, Rudolf Foundation Hospital, Ludwig Boltzmann Institute for Retinologie and Biomicroscopic Lasersurgery Juchgasse 25, A‐1030 Vienna, Austria

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Quote: "randomised (envelope method)"

Judgement comment: insufficient information regarding "envelope method"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "double‐blind study"

Judgement comment: described as “double masked” with no information on who was masked

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote: "prospective randomised double‐blind study"

Judgement comment: described as “double blind” with no information on who was masked

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Of the 80 patients (80 eyes) enrolled, 76 (95%) completed the study."

Judgement comment: high participant retention (95%)

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Nolan 2009

Methods

Study design: RCT

Study grouping: parallel group, involving 42 participants; it does not state whether the IOLs were unilaterally or bilaterally implanted

Exclusions after randomisation: one participant from the AIOL group withdrew after Visit 1 (V1), two after Visit 2 (V2), and two after Visit 4 (V4) (n = 5 withdrawals in total). Three participants from the ANIOL group withdrew after V1, two after V2, and two after V4 (n = 7 withdrawals in total). The reasons for withdrawal were as follows: illness (non‐ocular); participant deceased; logistics of transport; and not interested in participating further

Losses to follow‐up: Of the 42 participants recruited, 30 attended all study visits (one week before surgery, one week after surgery, and three, six, and 12 months after surgery: V1, V2, V3, V4, and V5, respectively)

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group (ANIOL group)

  • Number of participants: number of people (number of eyes): 21 (?)

  • Sex (number of women/number of men): 9/12

  • Age (mean ± SD): 74 ± 11 years

Non‐blue‐light filtering IOL group (AIOL group)

  • Number of participants: number of people (number of eyes): 21 (?)

  • Sex (number of women/number of men): 8/13

  • Age (mean ± SD): 71 ± 11 years

Inclusion criteria: people scheduled for cataract surgery at Waterford Regional Hospital

Exclusion criteria: pre‐operative logMAR visual acuity of less than 0.5 (the minimum required for reliable measurement of MPOD) and those with any evidence of macular disease

Comparison of study groups at baseline: groups were similar in age (P = 0.370) and sex distribution. The mean BMI was higher in the AIOL group compared with the ANIOL group (P = 0.017)

Interventions

Intervention characteristics

Blue‐light filtering IOL (ANIOL)

  • Type of IOL: AcrySof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOL (AIOL)

  • Type of IOL: AcrySof SA60AT single‐piece acrylic (Alcon)

Outcomes

The spatial profile of MPOD (i.e. at 0.25°, 0.5°, 1.0°, and 1.75° eccentricity) was measured with customised heterochromatic flicker photometry (cHFP) one week before and one week after surgery, and at three, six, and 12 months after surgery.

Serum concentrations of lutein and zeaxanthin were measured at each study visit.

BCVA, reported as a "Visual Acuity Rating" at 12 months postoperatively.

Identification

Sponsorship source:

Supported in full by Alcon Laboratories Inc., Fort Worth, Texas.

Disclosure: "J.M. Nolan, Alcon Laboratories Inc. (F); P. O’Reilly, Alcon Laboratories Inc. (F); J. Loughman, Alcon Laboratories Inc. (F); J. Stack, Alcon Laboratories Inc. (F); E. Loane, Alcon Laboratories Inc. (F); E. Connolly, Alcon Laboratories Inc. (F); S. Beatty, Alcon Laboratories Inc. (F) The publication costs of this article were defrayed in part by page charge payment. This article must therefore be marked “advertisement” in accordance with 18 U.S.C. §1734 solely to indicate this fact."

Country: Ireland

Setting: Waterford Regional Hospital, Ireland

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information provided for review

Authors name: John M. Nolan

Institution: Macula Pigment Research Group, Waterford Institute of Technology, Cork Road, Waterford, Ireland

Email: [email protected]

Address: Macula Pigment Research Group, Waterford Institute of Technology, Cork Road, Waterford, Ireland

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "The trial was conducted in a double‐blind, randomised, controlled fashion."

Judgement comment: described as “double blind” with no information on who was masked

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Judgement comment: described as “double blind” with no information on who was masked

Incomplete outcome data (attrition bias)
All outcomes

High risk

Quote: "Forty‐two patients were recruited. The patients were randomised to receive either the AIOL (n = 21) or the ANIOL (n = 21) implant as a lens replacement in their cataract surgery. Of the 42 patients recruited, 30 attended all study visits (one week before surgery, one week after surgery, and three, six, and 12 months after surgery: V1, V2, V3, V4, and V5, respectively). One patient from the AIOL group withdrew after V1, two after V2, and two after V4 (n = 5 withdrawals in total). Three patients from the ANIOL group withdrew after V1, two after V2, and two after V4 (n = 7 withdrawals in total). The reasons for withdrawal were as follows: patient illness (non‐ocular); patient deceased; logistics of transport; and not interested in participating further."

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

High risk

Quote: "Supported in full by Alcon Laboratories Inc., Fort Worth, Texas... The publication costs of this article were defrayed in part by page charge payment. This article must therefore be marked “advertisement” in accordance with 18 U.S.C. §1734 solely to indicate this fact."

Judgement comment: industry funding (Alcon Laboratories), who manufactured the interventions

Pandita 2007

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: not reported

Losses to follow‐up: 109 patients, from 120 randomised, completed the three‐month follow‐up. Of 120 participants (eyes), three were transferred to a distant destination, one developed cystoid macular edema, one became seriously ill, one died, two returned at the five‐month follow‐up, and three refused to return.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 36 (36)

  • Sex (number of women/number of men): 17/19

  • Age (mean ± SD): 59 ± 3 years

Blue‐light filtering IOL group 1 (SN60AT)

  • Number of participants: number of people (number of eyes): 37 (37)

  • Sex (number of women/number of men): 18/19

  • Age (mean ± SD): 61 ± 2.7 years

Blue‐light filtering IOL group 2 (SN60WF)

  • Number of participants: number of people (number of eyes): 36 (36)

  • Sex (number of women/number of men): 17/19

  • Age (mean ± SD): 63 ± 2.1 years

Inclusion criteria: people aged 50‐70 years and scheduled for phacoemulsification for uncomplicated senile cataracts with in‐the‐bag implantation of an AcrySof IOL.

Exclusion criteria: complicated cataract, coexisting ocular pathology, glaucoma, axial length greater than 25.0 mm, nondilating pupils, history of intraocular surgery, laser therapy, retinopathy, optic nerve or macular diseases, refusal or unable to maintain follow‐up, diabetes with or without retinopathy, preoperative and postoperative astigmatism greater than 1.5 diopters (D), residual posterior capsule plaque, postoperative best corrected visual acuity (BCVA) 20/25, and posterior capsule opacification. Eyes with intraoperative complications such as posterior capsule tear, zonular dialysis, or uveal manipulation.

Comparison of study groups at baseline: there was no statistically significant difference in visual acuity, age, and sex ratio between the three groups. Only 109 of the 120 randomised participants are included in the analysis and reported in baseline characteristics.

Interventions

Intervention characteristics

Non‐blue‐light filtering IOL

  • Type of IOL: AcrySof SA60AT (Alcon)

Blue‐light filtering IOL 1

  • Type of IOL: AcrySof SN60AT (Alcon)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof SN60WF (Alcon)

Outcomes

The main outcome measure was the difference in contrast sensitivity between IOLs at each spatial frequency. Contrast sensitivity, measured using the CSV‐1000E contrast sensitivity chart test face (Vector Vision) at three, six, 12, and 18 cycles per degrees (cpd) under photopic conditions (85 cd/m2) and mesopic conditions (2.7 cd/m2) with 4.0 mm and 6.0 mm fixed central apertures, with and without glare, at three months postoperatively.

The outcome measure was distance BCVA, measured at three months postoperatively.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned

Country: India

Setting: ladevi Cataract IOL Research Centre, Ahmedabad, India

Comments:

Date study conducted: December 2005‐February 2006

Trial registration number: not reported

Contacting study investigators: trials authors contacted on 14 August 2017 regarding contrast sensitivity unit of error (specifically, whether it was the SD or a different unit or error); no response was received to this email. As a result, we could not incorporate these data in a meta‐analysis.

Corresponding author's name: Dr Abhay R Vasavada

Institution: Iladevi Cataract Research Centre, Raghudeep Eye Clinic

Email: [email protected]

Corresponding author's address:

Abhay R. Vasavada

Iladevi Cataract IOL Research Centre

Raghudeep Eye Clinic, Gurukul Road, Memnagar, Ahmedabad–380 052, India

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Computer‐generated random numbers"

Judgement comment: computer generated list used to assign interventions

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "triple‐masked trial (neither participant nor investigator responsible for patients was aware of IOL type)"

Judgement comment: clearly stated that participants and personnel not aware of which treatment received

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Judgement comment: clearly stated that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "The drop‐out was 11 of 120 patients (9.2%)."

Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and equal follow‐up in both groups and no obvious reason why loss to follow‐up should be related to outcome.

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Raj 2005

Methods

Study design: RCT

Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: eyes with intraoperative complications such as posterior capsule tear, zonular dialysis, or uveal manipulation that could lead to postoperative cystoid macular oedema were also excluded. However, none of the patients were excluded because of intraoperative manipulations.

Losses to follow‐up: all participants maintained their follow‐up schedule, and none of the participants dropped out of the study.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 0/30

  • Age (mean ± SD): 62.3 ± 8.5 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 0/30

  • Age (mean ± SD): 62.3 ± 8.5 years

Inclusion criteria: people > 50 years of age with a congenital colour deficiency and senile bilateral uncomplicated cataracts with a visual acuity of > 20/200 on the Snellen visual acuity chart with all types of cataract: nuclear (type 1), cortical (types 2 and 3), posterior subcapsular (type 4), or mixed cataracts and all grades of cataract (in a nuclear sclerosis grading system from 1‐5)

Exclusion criteria: people with mature cataracts, traumatic cataracts, glaucoma, history of intraocular surgery, laser therapy, retinopathy, or optic nerve or macular diseases; who refused to or were unable to maintain follow‐up; with diabetes with or without retinopathy; and those on medications such as chloroquine, digitalis, and indomethacin. Eyes with intraoperative complications such as posterior capsule tear, zonular dialysis, or uveal manipulation that could lead to postoperative cystoid macular oedema

Comparison of study groups at baseline: paired‐eye study. All participants were moderate red–green anomalous trichromats. However, those randomised but excluded from the analysis were not adequately described.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof Natural SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Acrysof SA60AT (Alcon)

Outcomes

The main outcome measure was to detect an increase in the error scores on the Ishihara plates and an increase in the number of diametrical crossings in the circular diagram on the D‐15 test after implantation of AcrySof Natural IOL (blue‐light filtering IOL), at one month, three months and six months postoperatively.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in material or method mentioned.

Country: India

Setting: Iladevi Cataract IOL Research Centre, Raghudeep Eye Clinic

Comments:

Date study conducted: December 2002‐February 2004

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author's name: Abhay R Vasavada, MS, FRCS

Institution: Iladevi Cataract IOL Research Centre, Raghudeep Eye Clinic

Corresponding author's mail: [email protected]

Address:

Abhay R Vasavada

Iladevi Cataract IOL Research Centre

Raghudeep Eye Clinic Gurukul Road, Memnager Ahmedabad 380 052, India

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Low risk

Quote: "the circulating nurse in the operation theater opened 1 of the 30 preprepared envelopes containing 2 options:"

Judgement comment: random assignment with pre‐prepared envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "neither participant nor the investigator responsible for the patients knew the eye assigned."

Judgement comment: clearly stated that participants and personnel not aware of which treatment received

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote: "double‐masked trial (neither participant nor the investigator responsible for the patients knew the eye assigned to the test IOL)."

Judgement comment: although it states that the trial was "double‐masked" with respect to participants and investigators being masked, it is unclear whether outcome assessors were also masked.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: even though it states in exclusion criteria section "Eyes with intraocular complications... were also excluded" in the Results section it states "none of the patients was excluded because of intraocular manipulations." No participant dropout

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Rocha 2006a

Methods

Study design: RCT

Study grouping: parallel group trial involving a total of 120 eyes, with no further details provided

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): ? (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): ? (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): ? (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: AcrySof IQ (Alcon)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof Natural (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Sensar (AMO)

Outcomes

Distance BCVA, contrast sensitivity (Pelli–Robson chart, Optec® 6500, performed under photopic and mesopic conditions, with and without glare) and wavefront abberation analysis (total root mean square and mean higher order abberations), at 30 and 90 days postoperatively.

Identification

Sponsorship source:

Funding sources: none

Declaration of interest: none

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: K M Rocha

Institution: not reported

Email: not reported

Address: not reported

Notes

ARVO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in the absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in the absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information within abstract to judge other potential sources of bias

Rocha 2006b

Methods

Study design: RCT

Study grouping: parallel group, involving a total of 60 people and 120 eyes, with no further details regarding how data were analysed

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): Not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: AcrySof IQ (Alcon)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof Natural (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Sensar (AMO)

Outcomes

Total and high‐order wavefront aberrations and contrast sensitivity at 30 and 90 days postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

Corresponding author;s name: Karolline M Rocha, MD

Institution: not reported

Corresponding author's email: not reported

Address: not reported

Notes

AAO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information to judge other potential sources of bias from the abstract

Rocha 2007

Methods

Study design: RCT

Study grouping: parallel group, involving 60 participants (120 eyes) with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: not reported

Losses to follow‐up: one participant was lost at the 60‐day follow‐up visit because of unrelated health problems.

How missing data were handled: wavefront measurement for a 5‐mm pupil diameter was not acquired in 13 eyes with either decentered IOLs, capsular constriction, or a small capsulorhexis. 35 eyes in AcrySof IQ group, 36 eyes in AcrySof SN60AT group, and 34 eyes in the Sensar AR40 group completed all follow‐up examinations. Although specifics of how missing data were handled is not described.

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): 40 (40)

  • Sex (number of women/number of men): not reported

  • Age (mean): 69.9 years (unit of error not specified)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 40 (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ): 69.2 years (unit of error not specified)

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): 40 (40)

  • Sex (number of women/number of men): not reported

  • Age (mean): 71.0 years (unit of error not specified)

Inclusion criteria: people with visually significant bilateral senile cataracts, no other ocular diseases, corneal astigmatism less than 2.0 diopters (D), and potential acuity better than 0.2 logarithm of the minimum angle of resolution units (Guyton‐Minkowsky Potential Acuity Meter; MARCO Ophthalmic, Inc., Jacksonville, FL)

Exclusion criteria: people with glaucoma, retinal pathologic features, corneal opacities or irregularities, dry eye, amblyopia, anisometropia, intraoperative complications, and decentration between pupil and IOL more than 0.4 mm, estimated by retroillumination and digital photos

Comparison of study groups at baseline: there were no statistically significant differences in age, preoperative simulated mean keratometry, and axial length across study groups. Unclear whether baseline characteristics excludes some participants (15 eyes). It should also be noted that participants with intraoperative complications were excluded, and no data are provided in relation to these potential exclusions.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: AcrySof IQ (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Sensar AR40 (Allergan)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof SN60AT (Alcon)

Outcomes

Participants were examined before surgery and at one, seven, 15, 30, and 90 days after surgery.

The main outcome measures were spherical aberration and depth of focus (by means of distance‐corrected near and intermediate visual acuity) at 90 days after surgery.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: the authors have no financial interest in the technology described.

Country: Brazil

Setting: Department of Ophthalmology, Paulista School of Medicine, Federal University of São Paulo

Comments:

Date study conducted: February 2005‐October 2005

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Karolinne Maia Rocha, MD

Institution: Department of Ophthalmology, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil

Email: [email protected]

Corresponding author's address:

Karolinne Maia Rocha

Rua 3 de Maio, 130/124, São Paulo–SP, 04044‐020 Brazil

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and equal follow‐up in both groups and no obvious reason why loss to follow‐up was related to outcome

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Schmack 2012

Methods

Study design: RCT

Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: baseline characteristics exclude those potentially excluded post‐randomisation for various reasons including intraoperative and postoperative complications, and no details are provided about these potential participants.

Losses to follow‐up: three participants were lost to follow‐up because of private reasons (n = 2) and non‐study‐related medical reasons (n = 1).

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 22 (22)

  • Sex (number of women/number of men): 18/4

  • Age (mean ± unit of error): 73.5 ± 6.4 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 22 (22)

  • Sex (number of women/number of men): 18/4

  • Age (mean ± unit of error): 73.5 ± 6.4 years

Inclusion criteria: people who were sequentially admitted for bilateral cataract phacoemulsification with implantation of an IOL between April 2007 and November 2007; aged ≥ 50 years who were likely to complete all study visits and had a potential postoperative corrected distance visual acuity (CDVA) of 0.30 or better (logMAR).

Exclusion criteria: people with active or previous ocular disease of the cornea, iris, retina, or optic nerve with potential impact on the visual acuity; colour vision deficiency; intraocular inflammation (iritis or uveitis); monocular status; history of intraocular surgery; uncontrolled systemic disease; diabetes mellitus; neurologic disease; and unavailable for follow‐up. People with a preoperative cycloplegic pupil diameter of 5.0 mm or less and surgical or postoperative complications, including vitreous loss, capsule tears, or prolonged intraocular inflammation.

Comparison of study groups at baseline: participants received one each of a orange (blue‐light filtering) and clear (UV‐filtering) IOL. Baseline characteristics exclude those potentially excluded postrandomisation for various reasons including intraoperative and postoperative complications. There were no statistically significant differences in uncorrected distance visual acuity, corrected distance visual acuity, or contrast sensitivity with or without glare between the two IOL groups.

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Oculaid PC 440 Y Orange Series (Ophtec)

Non‐blue‐light filtering IOL

  • Type of IOL: Oculaid PC 430 Y Elite Series IOL (Ophtec)

Outcomes

Participants were evaluated at the time of enrolment (two days before surgery) and one month, three months, and six months after surgery for each eye.

Primary outcome measures were corrected distance visual acuity under scotopic (1 candela (cd)/m2) and photopic (85 cd/m2) conditions, colour vision, and contrast sensitivity with and without glare. Uncorrected distance visual acuity (UDVA) and patient satisfaction were defined as secondary outcome measures. The UDVA was tested under photopic conditions only.

The postoperative change in distance BCVA, considered as a dichotomous outcome, was interpreted from the reporting of the study results in Tables 2 and 3, which provides the range of BCVA values and indicates that there were no individuals with a loss of BCVA of at least three lines, in any of the study groups.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned

Country: Germany

Setting: Department of Ophthalmology, Ruhr University, Bochum, Germany

Comments:

Date study conducted: April 2007‐November 2007

Trial registration number: not reported

Contacting study investigators: study authors were emailed on 1 September 2017, for information regarding:

  • the means and standard deviations of the within‐pair differences for visual acuity and contrast sensitivity, at follow‐up;

  • P values from the repeated measures ANOVA or paired samples t‐test, for the outcomes detailed above;

  • information about the order effects: in the ANOVA model, was there a significant interaction between the order of implantation of different lens types and the type of lens (i.e., did yellow lens produce better/worse results if it was implanted first?).

No response was received after at least one month of contacting the authors, and as a result these data were not able to be included in our meta‐analyses.

First author's name: Ingo Schmack, MD

Institution: Department of Ophthalmology, Ruhr University

Email: ingo.schmack@kk‐bochum.de

Corresponding author's address:

Ingo Schmack

Department of Ophthalmology, Ruhr University

In der Schornau 23‐25, 44892 Bochum, German

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Quote: "Eye was randomised before IOL implantation using an envelope technique."

Judgement comment: trial is described as "randomised" and used "envelope technique" to conceal allocation but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "double‐blind randomised masked fashion."

Judgement comment: described as “double blind” with no specific information on whether participants and personnel were masked

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The individual who was responsible for the follow‐up examinations and data acquisition was blinded and not aware of which IOL was implanted in the eye being evaluated."

Judgement comment: clearly stated that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: reports the number (22 patients) who completed the study not how many were excluded post‐randomisation for "surgical or postoperative complications"

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Schmidinger 2008

Methods

Study design: RCT

Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: of the 31 participants (enrolled), one was excluded because of subjectively disturbing vitreous floaters and two because of previously undetected macular drusen

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 31 (31)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 73.4 ± 7.64 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 31 (31)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 73.4 ± 7.64 years

Inclusion criteria: people with no history of corneal disorders, no abnormal pupil reaction, no sign of inflammation, no opacification of optic media apart from cataract, and no retinal disorders.

Exclusion criteria: people with systemic disease or those having treatment known to affect colour perception. Based on specular microscopy, patients with evident signs of macular alteration or other ocular disease after surgery.

Comparison of study groups at baseline: all participants had a similar cataract grade in both eyes. Baseline age was reported for 28 of the 31 participants. It should be noted that "patients with evident signs of macular alteration or other ocular disease after surgery were not included in the study", however "no intraoperative or postoperative complications or adverse events occurred."

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AF‐1 (UY) (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: AF‐1 (UV) (Hoya)

Outcomes

Distance BCVA, colour contrast sensitivity (measured using heterochromic flicker), central and peripheral tritan colour contrast sensitivities (measured using the Moorfields Vision System, CH Electronics) at three months postoperatively.

The primary outcome measure was colour contrast sensitivity for short wavelengths of visible light at three months postoperatively.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author had a financial or proprietary interest in any material or method mentioned

Country: Austria

Setting: Medical University of Vienna, Department of Ophthalmology, Vienna, Austria

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Gerald Schmidinger, MD

Institution: Department of Ophthalmology, Medical University of Vienna

Email: [email protected]

Corresponding author's address:

Gerald Schmidinger

Department of Ophthalmology, Medical University of Vienna Waehringer Guertel 18‐20, A‐1090 Vienna, Austria

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "double‐blind study"

Judgement comment: study is described as "double‐blind" without specific information on how participants and personnel were masked

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The investigator performing the test was blind to the type of IOL implanted."

Judgement comment: clearly stated that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and no obvious reason why loss to follow‐up should be related to outcome

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Schmoll 2014

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: in all, 108 participants were recruited (including 21 age‐matched "control" participants, who did not receive an IOL and were not included these analyses), of whom 80 completed the study. Of the 28 who did not, 26 voluntarily declined to attend for the second test appointment, one had uncontrolled glaucoma and one required intercurrent hospital admission for an exacerbation of chronic obstructive pulmonary disease.

Losses to follow‐up: as described above

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 19 (19)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 40 (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: participants were voluntarily recruited from routine cataract assessment clinics after providing informed consent. Participants were included regardless of whether they were being assessed for first‐ or second‐eye cataract surgery, or as controls.

Exclusion criteria: participants unable to read the N48 test display on the reaction time task, those diagnosed with Parkinson’s Disease or dementia, any intercurrent illness requiring hospital admission, any previous ophthalmic history involving retinal damage including proliferative diabetic retinopathy, diabetic macular oedema, exudative AMD, central retinal artery or vein occlusion, and retinal detachment surgery.

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AcrySof SN60 WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Tecnis ZCB00 (AMO)

Outcomes

Choice reaction time (CRT) and the Epworth Sleepiness Score (ESS), at three months postoperatively

Identification

Sponsorship source:

Funding sources: not commissioned

Declaration of interest: no competing interests

Country: Scotland

Setting: St Johns Hospital, Livingston, United Kingdom

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Dr Conrad Schmoll

Institution: Princess Alexandra Eye Pavilion

Email: [email protected]

Corresponding author's address:

Conrad Schmoll

Princess Alexandra Eye Pavilion

45 Chalmers Street, Edinburgh EH3 9HA, UK

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "prospective randomised"

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "Participants undergoing first‐eye cataract surgery were randomised to receive either a blue‐blocking IOL (Alcon Acrysof SN60WF) or a UV‐blocking IOL (AMO Tecnis ZCB00), and were masked as to which IOL type had been implanted. Study protocol dictated that participants undergoing second‐eye cataract surgery would receive an identical lens to their previous one. These patients had not been issued with information cards after their first‐eye surgery and were therefore unaware of which lens type they received."

Judgement comment: participants were reported to be masked; although personnel were reported to be masked, this is not anticipated to significantly affect the study outcomes as most outcome measures were participant‐reported.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Judgement comment: unclear whether outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

High risk

Quote: "108 participants were recruited, of whom 80 completed the study. Of the 28 who did not, 26 voluntarily declined to attend for the second test appointment, one had uncontrolled glaucoma and one required intercurrent hospital admission for an exacerbation of chronic obstructive pulmonary disease."

Judgement comment: overall follow‐up < 80%, and follow‐up in each group not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Soriano 2006

Methods

Study design: RCT

Study grouping: parallel group, involving a total of 120 eyes (and an unspecified number of participants)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1

  • Number of participants: number of people (number of eyes): ? (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): ? (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Blue‐light filtering IOL group 2

  • Number of participants: number of people (number of eyes): ? (40)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: not reported

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: AcrySof SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Sensar (AMO)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof SN60WF (Alcon)

Outcomes

Near visual acuity, wave‐front analysis and pupil diameter at 60 days postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information provided for review

First author's name: Eduardo S Soriano, MD

Institution: not reported

Email: not reported

Corresponding author's address: not reported

Notes

AAO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated

Allocation concealment (selection bias)

Unclear risk

Quote: "randomised prospective study"

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information provided within abstract to judge other potential sources of bias

Ueda 2005

Methods

Study design: RCT

Study grouping: parallel group, involving 31 participants (although the number of eyes is not reported)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 16 (?)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error ‐ not specified): 71.1 ± 6.7 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 15 (?)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error ‐ not specified): 72.1 ± 6.6 years

Inclusion criteria: people with cataract aged 40 to 80 years

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: ENV‐13 (Menicon)

Non‐blue‐light filtering IOL

  • Type of IOL: ES‐13 (Menicon)

Outcomes

The mean fluorescein transmittance in vitreous by vitreous fluorophotometry, the cystoid macular oedema by fluorescence angiography, and the thickness of fovea by optical coherence tomography at three months and 12 months postoperatively

Identification

Sponsorship source:

Funding sources: none

Declaration of interest: none for all authors

Country: not reported

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: T Ueda

Institution: Ophthamology, Showa University, Tokyo, Japan

Email: not reported

Corresponding author's address: not reported

Notes

ARVO conference abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information provided within abstract to judge other potential sources of bias

Ueda 2006

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 14 (14)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): 12 (12)

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: 26 cataractous eyes of 26 patients scheduled for phacoemulsification and acrylic IOL implantation were enrolled in this study. The criteria used in this study were completely normal ophthalmic examination after pupil dilation, including visual acuity ≥ 20/30, intraocular pressure 21 mm Hg, no prior automated perimetry experience, and no family history of glaucoma

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: YA60BB (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: VA60BB (Hoya)

Outcomes

Mean deviation and pattern standard deviation on frequency doubling perimetry (24‐2 threshold) at three months postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Japan

Setting: Department of Ophthalmology, Nara Medical University

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Tetsuo Ueda, MD

Institution: Department of Ophthalmology, Nara Medical University, Japan

Email: tueda@naramed‐u.ac.jp

Corresponding author's address:

Tetsuo Ueda

Department of Ophthalmology

Nara Medical University, 840, Kashihara‐shi Nara, 634‐8522, Japan

Notes

None.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Quote: "IOL implanted intraoperatively was randomly selected from clear (VA60BB, HOYA) and yellow‐tinted lenses (YA60BB, HOYA), which only differed by color."

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Vuori 2006

Methods

Study design: RCT

Study grouping: parallel group, involving 37 people (52 eyes)

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: in the photographic analysis, two eyes of one participant in the Acrysof Natural IOL group were excluded because of a very lightly pigmented fundus

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants (number of eyes): 19 (25)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 72 ± 8 years

Non‐blue‐light filtering IOL group

  • Number of participants (number of eyes): 18 (27)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 73 ± 7 years

Inclusion criteria: white patients scheduled for phacoemulsification and IOL implantation

Exclusion criteria: hereditary colour vision defects; medications that might affect colour vision, such as ethambutol; any medication for epilepsy; amiodarone; digitalis; anti‐inflammatory drugs; diabetes; any other ocular pathology except cataract

Comparison of study groups at baseline: no apparent group differences, although this was not explicitly stated and sex of participants was not given

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Acrysof Natural ‐ model SN60AT (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Acrysof ‐ model SA60AT (Alcon)

Outcomes

Colour vision (measured using Standard pseudoisochromatic plates, part 2, (SPP2) (Ichikawa et al. 1983) and the FarnsworthMunsell 100‐hue test (FM 100) (Farnsworth 1957)) and visibility of the retinal nerve fibre layer, from retinal fundus photography at one to six months postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Finland

Setting: Department of Ophthalmology, Turku University Hopsital, Turku, Finland

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Marja‐Liisa Vuori, MD

Institution: Department of Ophthalmology Turku University Hospital, Kiinamyllynkatu 4–8, 20520 Turku, Finland

Email: marja‐[email protected]

Corresponding author's address:

Marja‐Liisa Vuori

Department of Ophthalmology

Turku University Hospital

Kiinamyllynkatu 4–820520 Turku, Finland

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Low risk

Quote: "Sealed envelopes containing the code for the planned IOL type were used for randomization.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Judgement comment: described as “double blind” with no information on who was masked

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Judgement comment: described as “double blind” with no information on who was masked

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: results suggest no participants were lost to follow‐up; although this is not explicitly stated

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: sex distribution between study groups at baseline is not reported; the significance of this baseline imbalance is not clear

Walter 2005

Methods

Study design: RCT

Study grouping: parallel group, involving 29 people (58 eyes), where both eyes received the same type of IOL but no further details are provided in relation to the statistical approach

Exclusions after randomisation: not reported

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± unit of error): not reported

Inclusion criteria: non‐amblyopic bilateral cataract patients aged 60‐80 years with inconspicuous (normal) colour recognition test (Ishihara)

Exclusion criteria: not reported

Comparison of study groups at baseline: not reported

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AF‐1 (UY) YA‐60BB (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: AF‐1 (UV) VA‐60BB (Hoya)

Outcomes

Visual acuity, contrast sensitivity and colour vision at six weeks and four and a half months postoperatively

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: Germany

Setting: not reported

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: S Walter

Institution: Universitäts‐Augenklinik Magdeburg, Germany

Email: Not reported

Corresponding author's address: not reported

Notes

Conference abstract, in German

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: study described as open label

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment:study described as open label

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Unclear risk

Judgement comment: insufficient information within abstract to judge other potential sources of bias

Wang 2010

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: randomised participants were excluded from the baseline data on the basis of intraoperative complications and no details about these potential exclusions were provided.

Losses to follow‐up: participants who were "unable to attend for follow‐up visits" (i.e., those with incomplete follow‐up) were excluded from the analyses. No details were provided in relation to those participants potentially excluded on these grounds.

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL 1 ‐ yellow

  • Number of participants: number of people (number of eyes): 41 (41)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): not reported

Non‐blue‐light filtering IOL

  • Number of participants: number of people (number of eyes): 38 (38)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): not reported

Blue‐light filtering IOL 2 ‐ photochromic

  • Number of participants: number of people (number of eyes): 39 (39)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): not reported

Inclusion criteria: this study enrolled consecutive eyes that had cataract surgery with IOL implantation from November 2008‐June 2009. The inclusion criteria were senile cataract, no previous ophthalmic surgery, a potential visual acuity of 0.5 or better, and no colour vision deficiency.

Exclusion criteria: people with congenital ocular abnormalities, glaucoma, proliferative diabetic retinopathy, retinal detachment, inflammatory signs, IOL power calculation < +10.00 diopters (D) or > +30.00 D, astigmatism greater than 2.00 D, intraoperative complications (e.g., posterior capsule rupture, bleeding), abnormal pupil reaction, or unable to attend the follow‐up visits.

Comparison of study groups at baseline: there were no significant differences in the demographic data reported for the three IOL groups. Randomised participants were excluded from the baseline data on the basis of intraoperative complications and no details about these potential exclusions were provided.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1 ‐ yellow

  • Type of IOL: AY‐1 (UY) (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: MC611MI IOL (HumanOptics AG)

Blue‐light filtering IOL 2 ‐ photochromic

  • Type of IOL: Aurium Matrix, Model 400 (Medennium, Inc.)

Outcomes

Postoperative visits were scheduled at one day, one week, and one and three months.

Outcomes were the postoperative uncorrected distance visual acuity, contrast sensitivity (testing using an Optec 6500 device (Stereo Optical Co.) at spatial frequencies of 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (cpd) and under photopic (85 candelas (cd)/m2), mesopic (3 cd/m2), photopic with glare (135 lux), and mesopic with glare (28 lux) lighting conditions), contrast vision (under 400 lux, 30 lux and 5 lux at 100%, 25%, and 5% contrast), hue discrimination (using the Farnsworth‐Munsell (FM) 100‐hue test under outdoor daylight conditions and indoor mesopic conditions), and the Catquest‐9SF patient questionnaire (which includes subjective evaluation of glare, halo and colour‐vision perception), at three months postoperatively.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned

Country: China

Setting: Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Ophthalmology Visual Sciences Key Laboratory, Beijing, China

Comments:

Date study conducted: November 2008‐June 2009

Trial registration number: not reported

Contacting study investigators: authors contacted on 14 August 2017 regarding the contrast sensitivity outcome unit of error (Figure 1); no response was received to this email and, as a result, we could not include these data in the meta‐analysis

First author's name: Jun Wang, MD

Institution: Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology Visual Sciences Key Laboratory

Email: [email protected]

Corresponding author's address:

Jun Wang

Beijing Tongren Eye Center, Beijing Tongren Hospital

Capital Medical University, Beijing Ophthalmology Visual Sciences Key Laboratory, Number 2 Chongnei Street, Bejing, China 100730

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Judgement comment: described as “double blind” with no information on whether participants and personnel were masked

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The physician who conducted the follow‐up examinations and collected the data was not aware which IOL had been implanted in the eye being evaluated."

Judgement comment: clearly states that outcome assessors were masked

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported, and participants with intraoperative complications were excluded, without specifying which groups these individuals were assigned to

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Wirtitsch 2009

Methods

Study design: RCT

Study grouping: parallel group, involving 24 people (48 eyes), with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)

Exclusions after randomisation: all included participants completed the scheduled vision tests and questionnaire

Losses to follow‐up: none

How missing data were handled: not applicable

Reported power size calculation? yes

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): not reported

Non‐blue‐light filtering IOL

  • Number of people (number of eyes): not reported

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): not reported

Overall

  • Number of people (number of eyes): 24 (48)

  • Sex (number of women/number of men): 18/6

  • Age (mean ± SD): 74 ± 8 years

Inclusion criteria: participants were recruited from a continuous cohort who presented with bilateral age‐related cataract in the outpatient centre of the Department of Ophthalmology, Hietzing Hospital, Vienna.

Exclusion criteria: amblyopia; pseudoexfoliation syndrome; primary or secondary glaucoma; ocular hypertension; uveitis; diabetes; history of intraocular surgery; laser treatment; retinal pathology; other relevant ophthalmic diseases. People with medication known to potentially cause ophthalmologic side effects; with an expected postoperative visual acuity less than 1.0 (20/20); congenital colour vision anomaly; ocular surface disease; ametropia of more than 3 diopters; with nicotine or alcohol abuse

Comparison of study groups at baseline: intra‐individual comparison (no group differences)

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: AF‐1 (UY) YA‐60BB (Hoya)

Non‐blue‐light filtering IOL

  • Type of IOL: AF‐1 (UV) VA‐60BB (Hoya)

Outcomes

Contrast acuity (measured at illumination levels of 500, 5, and 0.5 lux and contrast levels of 100%, 50%, 25%, 12.5%, and 6.25%), colour vision (assessed using the Lanthony desaturated D‐15 test, the Lanthony new colour test (Munsell chroma 2 and 4), and an anomaloscope), blue/yellow foveal threshold (using short‐wave automated perimetry) and the subjective visual impression of participants (evaluated using a questionnaire) at three months postoperatively

The main outcome measures were contrast acuity, colour vision, and foveal threshold.

Identification

Sponsorship source:

Funding sources: "This study did not receive any financial support."

Declaration of interest: "The authors have no proprietary interest in any of the materials or equipments mentioned in this study."

Country: Austria

Setting: Department of Ophthalmology, Hietzing Hospital, Vienna, Austria

Comments:

Date study conducted: surgery performed between December 2005 and February 2007

Trial registration number: clinicaltrials.gov NCT0061278

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Matthias G. Wirtitsch

Institution: Department of Ophthalmology, Hietzing Hospital

Email: [email protected]

Corresponding author's address:

Department of Ophthalmology, Hietzing Hospital Wolkersbergenstrasse 1, 1130 Vienna, Austria

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Quote: "The first eye was randomly assigned to receive a multipiece acrylic foldable IOL: either a Hoya AF‐1 (UY) YA‐60BB (both blue and UV light filter) or a Hoya AF‐1 (UV) VA‐60BB (only UV light filter) (both IOLs from Hoya Medical Europe, Frankfurt/ Main, Germany). The contralateral eye received the other IOL."

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "Patients and examiner were masked for IOL assignment."

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Study testing was performed in 1 single test session 90 plus/minus 10 days after surgery of the second eye by the same experienced and masked examiner."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "All included patients completed the scheduled vision tests and questionnaire."

Selective reporting (reporting bias)

Low risk

Judgement comment: all outcomes listed in trials registry (clinicaltrials.gov NCT 00612781) are reported

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Yamaguchi 2009

Methods

Study design: RCT

Study grouping: parallel group, involving 92 people (120 eyes), but with no further details regarding the allocation of interventions

Exclusions after randomisation: not reported. Participants could have been potentially excluded on the basis of intra‐ and postoperative complications, however no details were provided about any potential exclusions on these grounds.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1 (SN60WF)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 16/14

  • Age (mean ± SD): 68.7 ± 9.9 years

Non‐blue‐light filtering IOL group (aspheric ZA)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 14/16

  • Age (mean ± SD): 68.6 ± 3.8 years

Blue‐light filtering group 2 (SN60AT)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 20/10

  • Age (mean ± SD): 68.1 ± 8.7 years

Blue‐light filtering IOL group 3 (Hoya Py60AD)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 15/15

  • Age (mean ± SD): 68.5 ± 9.0 years

Inclusion criteria: consecutive eyes of patients who had cataract extraction and implantation of an acrylic IOL at Keio University Hospital between October 2007 and December 2008. People with significant senile cataract and a postoperative visual acuity better than 20/20 were eligible for inclusion in the study.

Exclusion criteria: people with previous or coexisting ocular pathology and intraoperative or postoperative complications

Comparison of study groups at baseline: the authors state "there were no significant differences between the groups in age, IOL power, or postoperative pupil diameters under photopic and mesopic conditions (P > 0.05, Mann‐Whitney U test)." However, participants could have been potentially excluded on the basis of intraoperative and postoperative complications.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: AcrySof SN60WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Tecnis ZA9003 (AMO)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof Natural SN60AT (Alcon)

Blue‐light filtering IOL 3

  • Type of IOL: PY‐60 AD (Hoya)

Outcomes

The main outcome was the postoperative higher‐order aberrations (HOAs) of the cornea and whole eye (measured under photopic and mesopic conditions), measured at one month postoperatively.

Other outcomes were corrected distance visual acuity, and pupil diameter under photopic and mesopic conditions, measured at one month postoperatively.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned.

Country: Japan

Setting: Keio University Hospital, Tokyo, Japan

Comments:

Date study conducted: October 2007‐December 2008

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Takefumi Yamaguchi, MD

Institution: Keio University School of Medicine, Japan

Email: [email protected]

Corresponding author's address:

Takefumi Yamaguchi

Keio University School of Medicine

Shinanomachi 35, Shinjuku‐ku, Tokyo, Japan.

Notes

Data presented in this paper for the blue‐light filtering IOLs (SN60WF and SN60AT), and the non‐blue‐light filtering IOL(Tecnis ZA9003) appear the same as in the Yamaguchi 2011 paper. The data for the PY‐60 AD (Hoya) blue‐light filtering IOL appear different.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "Exclusion criteria included previous or coexisting ocular pathology and intraoperative or postoperative complications."

Judgement comment: whether incomplete outcome data is relevant is unclear as patients with intraoperative or postoperative complications were excluded

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Yamaguchi 2011

Methods

Study design: RCT

Study grouping: parallel group, involving 92 people (120 eyes), but with no further details regarding the allocation of interventions

Exclusions after randomisation: not reported. Participants could have been potentially excluded on the basis of having complications during cataract surgery or postoperatively. The authors do state that "no eyes had any postoperative complication", but no details were provided in relation to potential intraoperative complications.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group 1 (SN60WF)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 16/14

  • Age (mean ± SD): 68.7 ± 9.9 years

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 14/16

  • Age (mean ± SD): 68.6 ± 3.8 years

Blue‐light filtering IOL group 2 (SN60AT)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 18/12

  • Age (mean ± SD): 68.1 ± 8.7 years

Blue‐light filtering IOL group 3 (PY60AD)

  • Number of participants: number of people (number of eyes): ? (30)

  • Sex (number of women/number of men): 15/15

  • Age (mean ± SD): 68.5 ± 9.0 years

Inclusion criteria: people with significant senile cataract and postoperative visual acuity better than 20/20 were eligible for inclusion in the study.

Exclusion criteria: people with previous or coexistent ocular pathology and complications during cataract surgery or postoperatively

Comparison of study groups at baseline: the authors state that "there was no significant difference in the average IOL powers, age, and postoperative refraction, astigmatism, and pupil diameters under photopic and mesopic conditions between the three types of aspheric and one type of spherical IOLs (Kruskal–Wallis test, p > 0.05)" for those eligible to participate. However, those with intraoperative complications were excluded, and there is no details about these potential events/participants. Also, some participants received bilateral implants but there was no description of first eye versus second eye.

Interventions

Intervention characteristics

Blue‐light filtering IOL 1

  • Type of IOL: Acrysof IQ SN60WF (Alcon)

Non‐blue‐light filtering IOL

  • Type of IOL: Tecnis ZA9003 (AMO)

Blue‐light filtering IOL 2

  • Type of IOL: AcrySof SN60AT (Alcon)

Blue‐light filtering IOL 3

  • Type of IOL: PY60AD (Hoya)

Outcomes

Contrast sensitivity, higher‐order aberrations of the whole eye, and pupil diameter under photopic and mesopic conditions were measured one month postoperatively. Higher‐order aberrations were decomposed into Zernike coefficients, calculated according to individual pupil diameter. The correlation between higher‐order aberrations and contrast sensitivity was evaluated.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: the authors report no conflicts of interest in this work

Country: Japan

Setting: Keio University Hospital, Japan

Comments:

Date study conducted: October 2007‐December 2009

Trial registration number: not reported

Contacting study investigators: study authors not contacted; no additional information used for review

First author's name: Takefumi Yamaguchi

Institution: Department of Ophthalmology, Keio University School of Medicine

Email: [email protected]

Corresonding author's address:

Takefumi Yamaguchi

Department of Ophthalmology

Keio University School of Medicine

Shinanomachi 35, Shinjuku, Tokyo, Japan

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: trial is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: trial is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, patients and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "Exclusion criteria were previous or coexistent ocular pathology and complications during cataract surgery or postoperatively."

Judgement comment: completeness of outcome data is unclear as participants with complications during cataract surgery were potentially excluded from the analysis

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

Yuan 2004

Methods

Study design: RCT

Study grouping: parallel group, with one eye per participant randomised to one of the interventions

Exclusions after randomisation: a total of 60 participants were originally randomised; the blue‐light filtering IOL group included 27 individuals (12 men, 15 women; as three patients were non‐compliant). No further details were provided.

Losses to follow‐up: not reported

How missing data were handled: not reported

Reported power size calculation? no

Participants

Baseline characteristics

Blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 27 (27)

  • Sex (number of women/number of men): 15/12

  • Age (mean): 70.33 years (unit of error not specified)

Non‐blue‐light filtering IOL group

  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 16/14

  • Age (mean): 67.06 years (unit of error not specified)

Inclusion criteria: people with senile cataract

Exclusion criteria: not reported

Comparison of study groups at baseline: there was no significant difference in visual acuities (0.80–1.02) between the yellow UV and ordinary UV IOL groups (P > 0.05) (note: it was unclear if this was at baseline or postoperative)

Interventions

Intervention characteristics

Blue‐light filtering IOL

  • Type of IOL: Hoya lens (not specified)

Non‐blue‐light filtering IOL

  • Type of IOL: not reported

Outcomes

Visual acuity, spatial contrast sensitivity (Stereo Optical, Chicago, Illinois, U.S.A.), colour vision (FM‐100, Munsell, New Windsor, New York, U.S.A.), and subjective sensation at one week to six months postoperatively

Participants were questioned about photophobia and cyanopsia.

Identification

Sponsorship source:

Funding sources: not reported

Declaration of interest: not reported

Country: China

Setting: Tianjin Medical University Eye Center

Comments:

Date study conducted: not reported

Trial registration number: not reported

Contacting study investigators: authors contacted on 14 August 2017 regarding the contrast sensitivity outcome unit of error; no response was received to this email, and as a result we could not include these data in the meta‐analysis

First author's name: Zhaoxu Yuan, MD, PhD

Institution: Medical Research Building, Scottand White Hospital

Email: [email protected]

Corresponding author's address:

Zhaoxu Yuan

Medical Research Building, Scottand White Hospital

702 SW HK Dodgen Loop, Temple, TX, USA 76504

Notes

None

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details

Allocation concealment (selection bias)

Unclear risk

Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, participants and personnel were not masked.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Judgement comment: no information provided on masking. We assume that in absence of reporting on this, outcome assessors were not masked.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Judgement comment: follow‐up not reported, although three participants in the blue‐light blocking IOL group were reported to be "non‐compliant" and appear to have been excluded from the analyses

Selective reporting (reporting bias)

Unclear risk

Judgement comment: no access to protocol or trials registry entry

Other bias

Low risk

Judgement comment: no other apparent sources of bias

AAO: American Academy of Ophthalmology
AMD: age‐related macular degeneration
ARVO: Association for Research in Vision and Ophthalmology
BCVA: best‐corrected visual acuity
BMI: body mass index
D: dioptre
HRQoL: health‐related quality of life
IOL: intraocular lens
RCT: randomised controlled trial
UCVA: uncorrected visual acuity

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Alexander 2014

Not a RCT

Alfonso 2007

Not a RCT

Chen 2013

Does not appear to be a RCT

Chiosi 2006

Does not appear to be a RCT

Cionni 2006

Not a RCT

Clarke 1989

Not a blue‐light filtering IOL

Cunha 2010

Does not appear to be a RCT

Feng 2016

Does not appear to be a RCT

Gavris 2006

Does not appear to be a RCT

Gibson 2008

Not a blue‐light filtering IOL

Hammond 2010

Not a RCT

Hayashi 2009

Not a RCT

Kraff 1985

Not a blue‐light filtering IOL

Lak 2007

Does not appear to be a RCT

Lavric 2014

Does not appear to be a RCT

Mayer 2005

Does not appear to be a RCT

Mayer 2006

Does not appear to be a RCT

Mester 2008b

Does not appear to be a RCT

Mester 2008c

Does not appear to be a RCT

Muller 2005

Does not appear to be a RCT

Munoz 2012

Not a RCT

Nagai 2015

Not a RCT

Nakamura 2006

Does not appear to be a RCT

Nishi 2013

Not a RCT

Rodriguez‐Galietero 2005a

Does not appear to be a RCT

Rodriguez‐Galietero 2005b

Does not appear to be a RCT

Shpak 2012

Does not appear to be a RCT

Stopyra 2012

Does not appear to be a RCT

Sun 2007

Does not appear to be a RCT

Tognetto 2003

Not a blue‐light filtering IOL

Wen 2012

Does not appear to be a RCT

Wohlfart 2007

Not a RCT

IOL: intraocular lens
RCT: randomised controlled trial

Characteristics of studies awaiting assessment [ordered by study ID]

Ji 2013

Methods

Awaiting translation

Participants

Awaiting translation

Interventions

Awaiting translation

Outcomes

Awaiting translation

Notes

Awaiting translation

Li 2009

Methods

Participants

Interventions

Outcomes

Notes

Unable to source paper

Shi 2008

Methods

Participants

Interventions

Outcomes

Notes

Unable to source paper

Characteristics of ongoing studies [ordered by study ID]

Nishi 2015

Trial name or title

The CLOCK‐IOL colour (Cataract surgery and circadian biological rhythm among Japanese older people with cataract in Nara, Kansai Region: Influence of Intraocular Lens Implantation) study

Methods

Parallel group, open‐label, RCT

Participants

Patients diagnosed as having cataracts in Nara Medical University Hospital (Japan), according to the following inclusion and exclusion criteria

Inclusion criteria

  • Patients scheduled for the first cataract surgery

  • Age ≥ 60 years

  • Cataract with grade ≥ 2 nuclear opacification according to Lens Opacities Classification System III

Exclusion criteria

  • Severe mental illness or dementia

  • Severe corneal opacities with difficulty in assessment of lens opacity or fundal examination

  • Glaucoma with a visual field deficit with least mean deviation > 14 dB (Humphrey perimeter)

  • Vitreous haemorrhage

  • Proliferative diabetic retinopathy

  • Macular oedema

  • AMD

  • Patients needing immediate cataract surgery

  • Patients needing combined cataract and glaucoma surgery or combined cataract surgery and vitrectomy

Interventions

Phacoemulsification with a small incision and implantation of an IOL. Participants will be randomly allocated to the clear or blue‐blocking IOL group in a ratio of 1:1. In the clear IOL group, a clear spherical IOL (SA60AT, Alcon, Fort Worth, USA) will be implanted. In the blue‐blocking, IOL group, a spherical blue‐blocking IOL (SN60AT) or an aspherical blue‐blocking IOL (SN60WF, Alcon, Fort Worth, USA) will be implanted in a randomly allocated 1:1 ratio.

Outcomes

Primary outcomes

The primary outcomes are mortality and the incidence of CVD, cancer and AMD after surgery

Secondary outcomes

The secondary outcomes are:

  • glucose/lipid metabolism indicators including glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), triglyceride (TG), low‐density lipoprotein cholesterol (LDL‐C) and high‐density lipoprotein cholesterol (HDL‐C)

  • obesity as determined by BMI and abdominal circumference

  • indicators of circadian rhythm, including urinary melatonin metabolite (6‐sulfatoxymelatonin (aMT6‐s)), wrist skin temperature and the circadian rhythm of physical activity

  • sleep quality based on actigraphic sleep quality, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS)

  • the presence of depressive symptoms assessed using the short version of the Geriatric Depression Scale (GDS‐15)

  • light sensitivity assessed by the post‐illumination pupil response (PIPR)

  • ophthalmic parameters including visual acuity, the amplitude of pseudoaccommodation, the thickness of the retina and choroid measured using spectral‐domain optical coherence tomography (SD‐OCT), density of the macular pigment, aberration and subjective visual function assessed using the National Eye Institute Visual Function Questionnaire (NEI VFQ25)

Starting date

As detailed in UMIN Clinical Trials Registry (UMIN ID: UMIN000014680), the recruitment status on 26 February 2018 was 'Open public recruitment', with the anticipated trial start date listed as 28 July 2014

Contact information

Tomo Nishi

Nara Medical University School of Medicine

Department of Ophthalmology

840 Shijo‐cho, Kashiharashi, Nara, Japan, 634‐8521

Email: tomon@naramed‐u.ac.jp

Notes

None

AMD: age‐related macular degeneration
BMI: body mass index
IOL: intraocular lens
RCT: randomised controlled trial

Data and analyses

Open in table viewer
Comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in distance best‐corrected visual acuity (BCVA) for single‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up). If studies did not report change in distance BCVA, we utilised data reported at the end of the follow‐up period. Show forest plot

2

131

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.03, 0.02]

Analysis 1.1

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 1 Change in distance best‐corrected visual acuity (BCVA) for single‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up). If studies did not report change in distance BCVA, we utilised data reported at the end of the follow‐up period..

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 1 Change in distance best‐corrected visual acuity (BCVA) for single‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up). If studies did not report change in distance BCVA, we utilised data reported at the end of the follow‐up period..

2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period. Show forest plot

4

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.2

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period..

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period..

3 Contrast sensitivity, measured in log Contrast Sensitivity at 6 months (acceptable follow‐up range of 3‐9 months) Show forest plot

2

79

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.14, 0.14]

Analysis 1.3

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 3 Contrast sensitivity, measured in log Contrast Sensitivity at 6 months (acceptable follow‐up range of 3‐9 months).

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 3 Contrast sensitivity, measured in log Contrast Sensitivity at 6 months (acceptable follow‐up range of 3‐9 months).

4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months; logCT) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.4

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months; logCT).

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months; logCT).

5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or OCT or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months) Show forest plot

3

808

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.21 [0.63, 7.68]

Analysis 1.5

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or OCT or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months).

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or OCT or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months).

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.1 Change in distance best‐corrected visual acuity (BCVA), between baseline and 12 months (accepting measures for 6‐18 months' follow‐up. If change in distance BCVA not reported, we have utilised data reported at the end of the follow‐up period).
Figuras y tablas -
Figure 4

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.1 Change in distance best‐corrected visual acuity (BCVA), between baseline and 12 months (accepting measures for 6‐18 months' follow‐up. If change in distance BCVA not reported, we have utilised data reported at the end of the follow‐up period).

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period.
Figuras y tablas -
Figure 5

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period.

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.2 Effect on photopic contrast sensitivity function, measured in log Contrast Threshold (%) using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (with an acceptable follow‐up range of 3‐9 months).
Figuras y tablas -
Figure 6

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.2 Effect on photopic contrast sensitivity function, measured in log Contrast Threshold (%) using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (with an acceptable follow‐up range of 3‐9 months).

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months) [logCT].
Figuras y tablas -
Figure 7

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months) [logCT].

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or optical coherence tomography or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months).
Figuras y tablas -
Figure 8

Forest plot of comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL, outcome: 1.5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or optical coherence tomography or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months).

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 1 Change in distance best‐corrected visual acuity (BCVA) for single‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up). If studies did not report change in distance BCVA, we utilised data reported at the end of the follow‐up period..
Figuras y tablas -
Analysis 1.1

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 1 Change in distance best‐corrected visual acuity (BCVA) for single‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up). If studies did not report change in distance BCVA, we utilised data reported at the end of the follow‐up period..

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period..
Figuras y tablas -
Analysis 1.2

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period..

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 3 Contrast sensitivity, measured in log Contrast Sensitivity at 6 months (acceptable follow‐up range of 3‐9 months).
Figuras y tablas -
Analysis 1.3

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 3 Contrast sensitivity, measured in log Contrast Sensitivity at 6 months (acceptable follow‐up range of 3‐9 months).

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months; logCT).
Figuras y tablas -
Analysis 1.4

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months; logCT).

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or OCT or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months).
Figuras y tablas -
Analysis 1.5

Comparison 1 Blue‐light filtering IOL vs non‐blue‐light filtering IOL, Outcome 5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or OCT or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months).

Summary of findings for the main comparison. Blue‐light filtering intraocular lenses (IOL) compared to non blue‐light filtering IOL for protecting macular health

Blue‐light filtering IOL compared to non‐blue‐light filtering IOL for protecting macular health

Patient or population: adults undergoing cataract surgery with IOL implantation
Setting: eye hospitals
Intervention: blue‐light filtering IOL
Comparison: non‐blue‐light filtering IOL

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with non‐blue‐light filtering IOL

Risk with blue‐light filtering IOL

Change in distance BCVA, between baseline and 12 months

Mean change in distance BCVA between baseline and 12 months was 0 logMAR

MD 0.01 logMAR lower
(0.03 lower to 0.02 higher)

131
(2 RCTs)

⊕⊕⊕⊝
Moderatea

A lower BCVA (in logMAR) indicates a higher level of visual acuity. Studies in this analysis reported data at the end of the follow‐up period rather than change from baseline.

Distance BCVA, considered as a dichotomous outcome (being the proportion of eyes that experienced loss of 15 or more letters from baseline BCVA), at six months

See comments

Not estimable

63
(2 RCTs)

⊕⊝⊝⊝
Very lowb,c

There were no eyes, in either intervention group that had a loss of 15 or more letters from baseline BCVA.

Contrast sensitivity function, measured in log Contrast Sensitivity at six months

No relevant combinable data available for this outcome

Colour discrimination, measured as the proportion of eyes that had a measurable loss from baseline using Farnsworth‐Munsell 100‐hue colour test score under photopic conditions at six months

No relevant combinable data available for this outcome

Proportion of participants with adverse events with a probable causal link with the study interventions at six months follow‐up

No relevant combinable data available for this outcome

Proportion of eyes that developed late‐stage AMD, being CNV and/or GA, at three years of follow‐up

See comments

Not estimable

50
(1 RCT)

⊕⊝⊝⊝
Very lowd

In the 1 trial (Kara Junior 2011) there were no eyes, in either intervention group that developed late‐stage AMD at five years of follow‐up.

Proportion of eyes that developed any stage of AMD at 12 months

See comments

Not estimable

144
(2 RCTs)

⊕⊝⊝⊝
Very lowe

In both studies, there were no eyes, in either intervention group that developed any stage of AMD over the nominated follow‐up period.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AMD: age‐related macular degeneration; BCVA: best‐corrected visual acuity; CI: confidence interval; CNV: choroidal neovascularisation; GA: geographic atrophy; MD: mean difference; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High‐certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate‐certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low‐certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low‐certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

aDowngraded for risk of bias (‐1). Data derive from two relatively small studies, with one (Caporossi 2009) judged to have a high risk of bias in both masking domains, and the other (Vuori 2006) having an unclear risk of bias in most domains.
bDowngraded for imprecision (‐2). Schmack 2012 excluded participants with surgical or postoperative complications, including vitreous loss, capsule tears or prolonged intraocular inflammation from the analysis, and hence did not capture these outcomes (which may affect BCVA) in this study. In addition, there were no events in either study group.
cDowngraded for risk of bias (‐1). Data derive from two relatively small studies (Leibovitch 2006; Schmack 2012), which both had an unclear risk of bias in at least three key domains.
dDowngraded for risk of bias (‐1) and imprecision (‐2). Data derive from one small trial involving 60 participants (Kara Júnior 2006), with an unknown risk of bias in multiple domains. In this trial, there were no events in either study group.
eDowngraded for risk of bias (‐2) and imprecision (‐1). Data derive from two small trials (Kara Junior 2011; Mester 2008a). The Kara Junior 2011 study has an unknown risk of bias in multiple domains, and we judged Mester 2008a as having a high risk of bias in multiple domains, including performance bias and detection bias. In both trials, there were no events in either study group.

Figuras y tablas -
Summary of findings for the main comparison. Blue‐light filtering intraocular lenses (IOL) compared to non blue‐light filtering IOL for protecting macular health
Table 1. Details of the intraocular lenses (IOLs) used as interventions in each study

Study

Blue‐light filtering IOL name(s)a (Manufacturer)

Non‐blue‐light filtering IOL name(s)a
(Manufacturer)

Aose 2006

YA‐60BB (Hoya)

AcrySof SA60AT (Alcon) or AcrySof MA60BM (Alcon) or VA‐60BB (Hoya)

Bandyopadhyay 2016

AcrySof Natural SN60AT (Alcon) or PC4406 (Optech)

AcrySof SA60AT (Alcon)

Barisic 2007

AcrySof Natural (Alcon)

AcrySof MA60BM (Alcon)

Behrens‐Baumann 2005

YA‐60BB (Hoya)

VA‐60BB (Hoya)

Bhattacharjee 2006

AcrySof Natural SN60AT (Alcon)

AcrySof SA60AT (Alcon)

Brøndsted 2014

Not reported

Not reported

Brøndsted 2015

AcrySof IQ SN60WF (Alcon)

AMO ZCBOO (Abbott Medical Optics)

Brøndsted 2017

AcrySof IQ SN60WF (Alcon)

AMO ZCBOO (Abbott Medical Optics)

Caporossi 2007

AcrySof Natural SN60AT (Alcon) or AcrySof IQ SN60WF (Alcon)

Sensar AR40e (Abbott Medical Optics) or Tecnis Z9000 (Abbott Medical Optics) or Sofport L161AO (Bausch & Lomb)

Caporossi 2009b

AcrySof Natural SN60AT (Alcon) or AcrySof IQ SN60WF (Alcon)

Sensar AR40e (Abbott Medical Optics) or Tecnis Z9000 (Abbott Medical Optics)

Cionni 2003

AcrySof SB30AL (Alcon)

AcrySof SA30AL (Alcon)

Cristobal 2005

AcrySof Natural SN60AT (Alcon)

AcrySof SA60AT (Alcon)

Cui 2009

AcrySof Natural SN60AT (Alcon) or AcrySof IQ SN60WF (Alcon)

Tecnis Z9001 (Abbott Medical Optics)

Cuthbertson 2009

AcrySof Natural SN60AT (Alcon) or AcrySof IQ SN60WF (Alcon)

Tecnis Z9000 (Abbott Medical Optics) or Cee On Edge (Abbott Medical Optics) or Akreos AO (Bausch & Lomb) or Akreos Adapt (Bausch & Lomb)

Espindle 2005

AcrySof Natural (Alcon)

AcrySof single‐piece (Alcon)

Espíndola 2012a

AcrySof Natural SN60AT (Alcon)

Akreos Fit (Bausch & Lomb) or Akreos AO (Bausch & Lomb) or AcrySof SA60AT as described in the methods (but appears to be inadvertently described as the MA60AC in the reporting of the results)

Falkner Radler 2008

AcrySof Natural (Alcon) or AF‐1 UY (Hoya)

AcrySof single‐piece (Alcon) or AF‐1 UV (Hoya)

Hahsler 2004

SN60 (Alcon)

SA60 (Alcon)

Hahsler 2005

YA (Hoya) or SN60 (Alcon)

VA (Hoya) or SA60 (Alcon)

Hayashi 2006

YA‐60BB (Hoya)

VA‐60BB (Hoya)

Hyunseok 2007

AcrySof Natural SN60AT (Alcon)

Tecnis ZA9003 (Abbott Medical Optics)

Kara Junior 2011

AcrySof Natural SN60AT (Alcon)

AcrySof SA60AT (Alcon)

Kara Júnior 2006

AcrySof Natural SN60AT (Alcon)

AcrySof MA30AC (Alcon)

Kennis 2004

AcrySof Natural SN60AT (Alcon)

Tecnis Z9000 (Pfizer) or Opti‐Edge (Abbott Medical Optics)

Kim 2011a

AcrySof IQ SN60WF (Alcon)

OII Biovue3 (BioVue) or YA60BBR (Hoya)

Kim 2011b

AcrySof IQ SN60WF (Alcon)

Tecnis Z9003 (Abbott Medical Optics)

Kuchenbecker 2004

YA‐60BB (Hoya)

VA‐60BB (Hoya)

Leibovitch 2006

AcrySof Natural SN60AT (Alcon)

AcrySof single‐piece SA60AT (Alcon)

Marshall 2005

AcrySof Natural IOL SB30AL (Alcon) (the current marketed version of this lens is the SN60AT)

AcrySof SA30AL (Alcon)

Mester 2008a

AF‐1 UY (Hoya)

AF‐1 UV (Hoya)

Monnet 2009

AcrySof SN60AT (Alcon)

AcrySof MA60AC (Alcon) or AcrySof SA60AT (Alcon)

Neumaier‐Ammerer 2010

AF1 UY (Hoya) or AcrySof SN60AT (Alcon)

AF1 UV (Hoya) or AcrySof SA60AT (Alcon)

Nolan 2009

AcrySof Natural SN60AT (Alcon)

AcrySof SA60AT (Alcon)

Pandita 2007

AcrySof SN60AT (Alcon) or AcrySof SN60WF (Alcon)

AcrySof SA60AT (Alcon)

Raj 2005

AcrySof Natural SN60AT (Alcon)

AcrySof SA60AT (Alcon)

Rocha 2006a

AcrySof IQ (Alcon) or AcrySof Natural (Alcon)

Sensar (Abbott Medical Optics)

Rocha 2006b

AcrySof IQ (Alcon) or AcrySof Natural (Alcon)

Sensar (Abbott Medical Optics)

Rocha 2007

AcrySof IQ (Alcon) or AcrySof SN60AT (Alcon)

Sensar AR40 (Allergan)

Schmack 2012

Oculaid PC 440Y Orange Series (Ophtec BV)

Oculaid PC 430Y Elite Series (Ophtec BV)

Schmidinger 2008

AF‐1 UY (Hoya)

AF‐1 UV (Hoya)

Schmoll 2014

AcrySof SN60WF (Alcon)

Tecnis ZCB (Abbott Medical Optics)

Soriano 2006

AcrySof SN60AT (Alcon) or AcrySof SN60WF (Alcon)

Sensar (Abbott Medical Optics)

Ueda 2005

ENV‐13 (Menicon)

ES‐13 (Menicon)

Ueda 2006

YA‐60BB (Hoya)

VA‐60BB (Hoya)

Vuori 2006

AcrySof Natural SN60AT (Alcon)

AcrySof SA60AT (Alcon)

Walter 2005

AF‐1 YA‐60BB (Hoya)

AF‐1 UV‐60BB (Hoya)

Wang 2010

AY‐1 UY (Hoya) or Arium Matrix Model 4000 (Medennium)

MC611MI (HumanOptics)

Wirtitsch 2009

YA‐60BB (Hoya)

VA‐60BB (Hoya)

Yamaguchi 2009

AcrySof SN60WF (Alcon) or AcrySof SN60AT (Alcon) or Py60AD (Hoya)

Tecnis Z9003 (Abbott Medical Optics)

Yamaguchi 2011

AcrySof SN60WF (Alcon) or AcrySof SN60AT (Alcon) or Py60AD (Hoya)

Tecnis Z9003 (Abbott Medical Optics)

Yuan 2004

Not reported (Hoya)

Not reported (not reported)

aDetails of the interventions are provided as per the details available in the included studies.
bCaporossi 2009, reported two‐year follow‐up data for four out of five of the intervention groups from the Caporossi 2007 study (data from the Sofport L161AO group were not provided, although no explanation was provided).

Figuras y tablas -
Table 1. Details of the intraocular lenses (IOLs) used as interventions in each study
Table 2. Adverse effects: intraoperative complications

Study

Study population:

number of participants (number of eyes)

Number of intraoperative complication(s)

Details of intraoperative complication(s)

Bandyopadhyay 2016

Blue‐light filtering IOLs: n = 65 (65); this group combined individuals assigned to 2 different blue‐light filtering IOLs

Non‐blue‐light filtering IOL: n = 33 (33)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Barisic 2007

Blue‐light filtering IOL: n = 30 (60)

Non‐blue‐light filtering IOL: n = 30 (60)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Caporossi 2007

Blue‐light filtering IOL: n = 50 (100); this group combined individuals assigned to 2 different blue‐light filtering IOLs

Non‐blue‐light filtering IOL: n = 75 (150); this group combined individuals assigned to 3 different non‐blue‐light filtering IOLs

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Cui 2009

Blue‐light filtering IOL: n = 39 (41)

Non‐blue‐light filtering IOL: n = 18 (20)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Cuthbertson 2009

Overall: n = 31 (31)

Not reported

One participant developed endophthalmitis and was removed from the trial, being replaced (after re‐randomisation) by another individual. There was one anterior capsular rim tear and one posterior capsule tear without vitreous loss. No details were provided in relation to which group(s) the adverse events occurred in.

Espíndola 2012a

Blue‐light filtering IOL: n = 27 (27)

Non‐blue‐light filtering IOL: n = 52 (77)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Falkner Radler 2008

Blue‐light filtering IOL: n = 30 (30)

Non‐blue‐light filtering IOL: n = 30 (30)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Kim 2011a

Blue‐light filtering IOL: n = ? (42)

Non‐blue‐light filtering IOL: n = ? (26)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Kim 2011b

Blue‐light filtering IOL: n = 23 (23)

Non‐blue‐light filtering IOL: n = 16 (16)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Leibovitch 2006

Blue‐light filtering IOL: n = 9 (9)

Non‐blue‐light filtering IOL: n = 10 (10)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Marshall 2005

Blue‐light filtering IOL: n = 150 (300)

Non‐blue‐light filtering IOL: n = 147 (294)

Blue‐light filtering IOL: n = 1

Non‐blue‐light filtering IOL: none

There was one case of lens dislocation during surgery in the blue‐light filtering IOL group, in a case in which a posterior capsule rupture had occurred during cataract extraction.

Monnet 2009

Blue‐light filtering IOL: n = 19 (19)

Non‐blue‐light filtering IOL: n = 40 (40); this group combined individuals assigned to 2 different non‐blue‐light filtering IOLs.

Blue‐light filtering IOL: n = 2

Non‐blue‐light filtering IOL: none

In the blue‐light filtering IOL lens group "two IOLs were placed with 1 haptic in the capsular bag and 1 haptic outside the capsular bag; these 2 patients were also excluded from the final statistical analysis."

Pandita 2007

Blue‐light filtering IOL: n = 73 (73); this group combined individuals assigned to 2 different blue‐light filtering IOLs.

Non‐blue‐light filtering IOL: n = 36 (36)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Raj 2005

Blue‐light filtering IOL: n = 30 (30)

Non‐blue‐light filtering IOL: n = 30 (30)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Schmidinger 2008

Blue‐light filtering IOL: n = 31 (31)

Non‐blue‐light filtering IOL: n = 31 (31)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

Vuori 2006

Blue‐light filtering IOL: n = 19 (25)

Non‐blue‐light filtering IOL: n = 18 (27)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Not applicable

IOL: intraocular lens

Figuras y tablas -
Table 2. Adverse effects: intraoperative complications
Table 3. Adverse effects: postoperative complications and Nd:YAG capsulotomies

Study

Study population: number of participants (number of eyes)

Number of postoperative complication(s)

Details of postoperative complication(s)

Bandyopadhyay 2016

Blue‐light filtering IOLs: n = 65 (65); this group combined individuals assigned to 2 different blue‐light filtering IOLs.

Non‐blue‐light filtering IOL: n = 33 (33)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at four weeks of follow‐up

Barisic 2007

Blue‐light filtering IOL: n = 30 (60)

Non‐blue‐light filtering IOL: n = 30 (60)

Blue‐light filtering IOL: n = 3 eyes

Non‐blue‐light filtering IOL: n = 4 eyes

Although the study authors reported that "there were no postoperative complications", n = 3 eyes from the blue‐light filtering IOL group and n = 4 eyes from the non‐blue‐light filtering IOL group required Nd:YAG capsulotomy at six months of follow‐up.

Brøndsted 2015

Blue‐light filtering IOL: n = 38 (38)

Non‐blue‐light filtering IOL: n = 35 (35)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at six months of follow‐up.

Caporossi 2007

Blue‐light filtering IOL: n = 50 (100); this group combined individuals assigned to 2 different blue‐light filtering IOLs.

Non‐blue‐light filtering IOL: n = 75 (150); this group combined individuals assigned to three different non‐blue‐light filtering IOLs.

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at two months of follow‐up

Caporossi 2009

Blue‐light filtering IOL: n = 50 (100); this group combined individuals assigned to 2 different blue‐light filtering IOLs

Non‐blue‐light filtering IOL: n = 50 (100); this group combined individuals assigned to 2 different non‐blue‐light filtering IOLs

Blue‐light filtering IOL: n = 1 for Nd:YAG capsulotomy

Non‐blue‐light filtering IOL: n = 1 for Nd:YAG capsulotomy

This study reports the two‐year follow‐up data for a subset of participants from Caporossi 2007. The study authors reported that "patients who underwent a capsulotomy before two‐year follow‐up (two patients) were excluded as it was not possible to perform aberrometric analysis. Two Nd:YAG laser capsulotomies were required in two patients who had AcrySof SN60AT IOL (blue‐light filtering IOL) and Tecnis Z9000 IOL (non‐blue‐light filtering IOL) implantation."

Cui 2009

Blue‐light filtering IOL: n = 39 (41); this group combined individuals assigned to 2 different blue‐light filtering IOLs.

Non‐blue‐light filtering IOL: n = 18 (20)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at two months of follow‐up

Espíndola 2012a

Blue‐light filtering IOL: n = 27 (27)

Non‐blue‐light filtering IOL: n = 52 (77)

Blue‐light filtering IOL: none for glaucoma or Nd:YAG capsulotomy

Non‐blue‐light filtering IOL: none for glaucoma or Nd:YAG capsulotomy

The study authors reported that "at two years after surgery, all lenses were well centered and there was no evidence of posterior capsule opacity or glaucoma."

Falkner Radler 2008

Blue‐light filtering IOL: n = 30 (30)

Non‐blue‐light filtering IOL: n = 30 (30)

Blue‐light filtering IOL: n = 3 eyes

Non‐blue‐light filtering IOL: n = 1 eye

Blue‐light filtering IOL:

n = 1 postoperative iris capture,

n = 1 spontaneously reabsorbed vitreous haemorrhage,

n = 1 cystoid macular oedema at nine months after surgery

Non‐blue‐light filtering IOL: n = 1 postoperative iris capture

Kim 2011b

Blue‐light filtering IOL: n = 23 (23)

Non‐blue‐light filtering IOL: n = 16 (16)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at eight weeks of follow‐up

Hayashi 2006

Blue‐light filtering IOL: n = 38 (38)

Non‐blue‐light filtering IOL: n = 36 (36)

(In both groups, data were obtained from both eyes and averaged)

Glare symptoms

Blue‐light filtering IOL: n = 3 participants

Non‐blue‐light filtering IOL: n = 2 participants

Cyanopsia

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Postoperative complications (as measured by participant report of glare symptoms and cyanopsia) at three months after surgery

One participant was reported to have a clinically significant epiretinal membrane in the macula (it is unclear which group the participant belonged to)

Kara Junior 2011

Blue‐light filtering IOL: n = 30 (30)

Non‐blue‐light filtering IOL: n = 30 (30)

"Three patients required neodymium:YAG laser capsulotomy for posterior capsule opacification," however group allocations were not specified.

Three participants (although this was not distinguished by the IOL intervention) at five years of follow‐up

Kim 2011a

Blue‐light filtering IOL: n = 23 (23)

Non‐blue‐light filtering IOL: n = 16 (16)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at eight weeks of follow‐up

Leibovitch 2006

Blue‐light filtering IOL: n = 9 (9)

Non‐blue‐light filtering IOL: n = 10 (10)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at six months of follow‐up

Marshall 2005

Blue‐light filtering IOL: n = 150 (300)

Non‐blue‐light filtering IOL: n = 147 (294)

Blue‐light filtering IOL: n = 12

Non‐blue‐light filtering IOL: n = 6

At six months of follow‐up, in the blue‐light filtering IOL group, six eyes developed cystoid macula oedema and six eyes required secondary surgical intervention; none of the occurrences were considered IOL‐related.

At six months of follow‐up, in the non‐blue‐light filtering IOL group, three eyes developed cystoid macula oedema and three eyes required secondary surgical intervention; none of the occurrences were considered IOL‐related.

The study authors stated that "no Nd:YAG capsulotomy was performed in the first‐eye subgroup in either the test or control groups throughout the study period."

Monnet 2009

Blue‐light filtering IOL: n = 19 (19)

Non‐blue‐light filtering IOL: n = 40 (40); this group combined individuals assigned to 2 different non‐blue‐light filtering IOLs.

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at three months of follow‐up

Schmidinger 2008

Blue‐light filtering IOL: n = 31 (31)

Non‐blue‐light filtering IOL: n = 31 (31)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at three months of follow‐up

Wang 2010

Blue‐light filtering IOL: n = 80 (80); this group combined individuals assigned to 2 different blue‐light filtering IOLs.

Non‐blue‐light filtering IOL: n = 38 (38)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

None at 3 months of follow‐up

Vuori 2006

Blue‐light filtering IOL: n = 19 (25)

Non‐blue‐light filtering IOL: n = 18 (27)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

The study authors stated that "in the biomicroscopic examination (at one month postoperatively) the posterior capsule appeared clear in all test eyes."

Yamaguchi 2011

Blue‐light filtering IOL: n = ? (120); this group combined individuals assigned to 3 different blue‐light filtering IOLs.

Non‐blue‐light filtering IOL: n = ? (30)

Blue‐light filtering IOL: none

Non‐blue‐light filtering IOL: none

Reported at one month of follow‐up

IOL: intraocular lens

Figuras y tablas -
Table 3. Adverse effects: postoperative complications and Nd:YAG capsulotomies
Comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in distance best‐corrected visual acuity (BCVA) for single‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months' follow‐up). If studies did not report change in distance BCVA, we utilised data reported at the end of the follow‐up period. Show forest plot

2

131

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.03, 0.02]

2 Change in distance best‐corrected visual acuity (BCVA) for paired‐eye trials, between baseline and 12 months (accepted measures for 6‐18 months follow‐up. If change in distance BCVA was not reported, we utilised data reported at the end of the follow‐up period. Show forest plot

4

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 Contrast sensitivity, measured in log Contrast Sensitivity at 6 months (acceptable follow‐up range of 3‐9 months) Show forest plot

2

79

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.14, 0.14]

4 Contrast sensitivity function, measured in log Contrast Sensitivity, using the mid‐range of the available spatial frequencies (between 6‐12 cycles/deg) at 6 months (acceptable follow‐up range of 3‐9 months; logCT) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Proportion of eyes with a finding of pathological structural change at the macula, detected by clinical observation or OCT or retinal fundus photography, at 12 months (acceptable follow‐up range of 6‐18 months) Show forest plot

3

808

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.21 [0.63, 7.68]

Figuras y tablas -
Comparison 1. Blue‐light filtering IOL vs non‐blue‐light filtering IOL