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Queratomileusis in situ asistida por láser (LASIK) con un microquerátomo mecánico en comparación con la LASIK con un láser de femtosegundo para la LASIK en adultos con miopía o astigmatismo miópico

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Referencias

Referencias de los estudios incluidos en esta revisión

Ir a:

Buzzonetti 2008 {published data only}

Buzzonetti L, Petrocelli G, Valente P, Tamburrelli C, Mosca L, Laborante A, et al. Comparison of corneal aberration changes after laser in situ keratomileusis performed with mechanical microkeratome and IntraLase femtosecond laser: 1-year follow-up. Cornea 2008;27(2):174-9. CENTRAL

Durrie 2005 {published data only}

Durrie DS, Kezirian GM. Femtosecond laser versus mechanical keratome flaps in wavefront-guided laser in situ keratomileusis: prospective contralateral eye study. Journal of Cataract and Refractive Surgery 2005;31(1):120-6. CENTRAL

Gui‐Hong 2018 {published data only}

Gui-Hong Xu, Zhen-Zhen Wu, Xiao-Hong Gu. Influence of microkeratome and femtosecond laser on vision and corneal flap thickness used in corneal flap making. Guoji Yanke Zazhi 2018;18(5):894-6. CENTRAL

Hasimoto 2013 {published data only}

Hasimoto AR, Gomes MF, de Siqueira MA, Moreira H. Femtosecond laser versus mechanical microkeratome for LASIK flap creation. Arquivos Brasileiros de Oftalmologia 2013;76(6):335-8. CENTRAL

Manche_group 2008 {published data only}

Chan A, Ou J, Manche EE. Comparison of the femtosecond laser and mechanical keratome for laser in situ keratomileusis. Archives of Ophthalmology 2008;126(11):1484-90. CENTRAL
Golas L, Manche EE. Dry eye after laser in situ keratomileusis with femtosecond laser and mechanical keratome. Journal of Cataract and Refractive Surgery 2011;37(8):1476-80. CENTRAL

Patel_group 2010 {published data only}

Calvo R, McLaren JW, Hodge DO, Bourne WM, Patel SV. Corneal aberrations and visual acuity after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. American Journal of Ophthalmology 2010;149(5):785-93. CENTRAL
Klingler KN, McLaren JW, Bourne WM, Patel SV. Corneal endothelial cell changes 5 years after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. Journal of Cataract and Refractive Surgery 2012;38(12):2125-30. CENTRAL
McLaren JW, Bourne WM, Maguire LJ, Patel SV. Changes in keratocyte density and visual function five years after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. American Journal of Ophthalmology 2015;160(1):163-70. CENTRAL
Patel SV, Maguire LJ, McLaren JW, Hodge DO, Bourne WM. Femtosecond laser versus mechanical microkeratome for LASIK: a randomized controlled study. Ophthalmology 2007;114(8):1482-90. CENTRAL
Patel SV, McLaren JW, Kittleson KM, Bourne WM. Subbasal nerve density and corneal sensitivity after laser in situ keratomileusis: femtosecond laser vs mechanical microkeratome. Archives of Ophthalmology 2010;128(11):1413-9. CENTRAL

Salomão 2009 {published data only}

Salomão MQ, Ambrósio R Jr, Wilson SE. Dry eye associated with laser in situ keratomileusis: mechanical microkeratome versus femtosecond laser. Journal of Cataract and Refractive Surgery 2009;35(10):1756-60. CENTRAL

Tan 2007 {published data only}

Tan CS, Au Eong KG, Lee HM. Visual experiences during different stages of LASIK: Zyoptix XP microkeratome vs IntraLase femtosecond laser. American Journal of Ophthalmology 2007;143(1):90-6. CENTRAL

Tran 2005 {published data only}

Tran DB, Sarayba MA, Bor Z, Garufis C, Duh YJ, Soltes CR, et al. Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes: potential impact on wavefront-guided laser in situ keratomileusis. Journal of Cataract and Refractive Surgery 2005;31(1):97-105. CENTRAL

Zhai 2013 {published data only}

Zhai CB, Tian L, Zhou YH, Zhang QW, Zhang J. Comparison of the flaps made by femtosecond laser and automated keratomes for sub-bowman keratomileusis. Chinese Medical Journal 2013;126(13):2440-4. CENTRAL

Zhou 2012 {published data only}

Zhou Y, Zhang J, Tian L, Zhai C. Comparison of the Ziemer FEMTO LDV femtosecond laser and Moria M2 mechanical microkeratome. Journal of Refractive Surgery 2012;28(3):189-94. CENTRAL

Referencias de los estudios excluidos de esta revisión

Ir a:

AlArfaj 2014 {published data only}

AlArfaj K, Hantera MM. Comparison of LASEK, mechanical microkeratome LASIK and femtosecond LASIK in low and moderate myopia. Saudi Journal of Ophthalmology 2014;28(3):214-9. CENTRAL

Alió 2008 {published data only}

Alió Jl, Piñero DP. Very high-frequency digital ultrasound measurement of the LASIK flap thickness profile using the IntraLase femtosecond laser and M2 and Carriazo-Pendular microkeratomes. Journal of Refractive Surgery 2008;24(1):12-23. CENTRAL

Avetisov 2016 {published data only}

Avetisov SE, Mamikonyan VR, Shmeleva-Demir OA, Karamyan AA, Bubnova IA, Kazaryan EE, et al. Intraocular pressure, ocular blood flow, and corneal biomechanics changes after LASIK surgery for myopia. Vestnik Oftalmologii 2016;132(4):24-8. CENTRAL

Brar 2008 {published data only}

Brar GS, Grewal DS, Jain R, Grewal SP. Changes in elevation and corneal volume following LASIK with flap creation using IntraLase, mechanical keratome and LASEK. Investigative Ophthalmology and Visual Science 2008;49:ARVO E – abstract 2441. CENTRAL

Cañadas 2013 {published data only}

Cañadas P, de Benito-Llopis L, Hernández-Verdejo JL, Teus MA. Comparison of keratocyte density after femtosecond laser vs mechanical microkeratome from 3 months up to 5 years after LASIK. Graefe's Archive for Clinical and Experimental Ophthalmology 2013;251(9):2171-9. CENTRAL

Cosar 2013 {published data only}

Cosar CB, Gonen T, Moray M, Sener AB. Comparison of visual acuity, refractive results and complications of femtosecond laser with mechanical microkeratome in LASIK. International Journal of Ophthalmology 2013;6(3):350-5. CENTRAL

Elmohamady 2018 {published data only}

Elmohamady MN, Abdelghaffar W, Daifalla A, Salem T. Evaluation of femtosecond laser in flap and cap creation in corneal refractive surgery for myopia: a 3-year follow-up. Clinical Ophthalmology 2018;12:935-42. CENTRAL

Erie 2006 {published data only}

Erie JC, Patel SV, McLaren JW, Bourne WM. Corneal nerve morphology and function after bladeless and microkeratome LASIK. A randomized-controlled study. Investigative Ophthalmology and Visual Science 2006;47:ARVO E – abstract 516. CENTRAL

Grewal 2011 {published data only}

Grewal DS, Brar GS, Grewal SP. Posterior corneal elevation after LASIK with three flap techniques as measured by Pentacam. Journal of Refractive Surgery 2011;27(4):261-8. CENTRAL

Hamilton 2008 {published data only}

Hamilton DR, Johnson RD, Lee N, Bourla N. Differences in the corneal biomechanical effects of surface ablation compared with laser in situ keratomileusis using a microkeratome or femtosecond laser. Journal of Cataract and Refractive Surgery 2008;34(12):2049-56. CENTRAL

He 2017 {published data only}

He F, Tan HX. Comparative study of clinical efficacy after LASIK with corneal flap created by femtosecond laser and microkeratome. International Eye Science 2017;17(11):2120-22. CENTRAL

Hosny 2013 {published data only}

Hosny M, Zaki RM, Ahmed RA, Khalil N, Mostafa HM. Changes in retinal nerve fiber layer thickness following mechanical microkeratome-assisted versus femtosecond laser-assisted LASIK. Clinical Ophthalmology 2013;7:1919-22. CENTRAL

Hu 2015 {published data only}

Hu L, Xie W, Tang L, Chen J, Zhang D, Yu P, et al. Corneal subbasal nerve density changes after laser in situ keratomileusis with mechanical microkeratome and femtosecond laser. Chung-Hua Yen Ko Tsa Chih 2015;51(1):39-44. CENTRAL

Hussain 2015 {published data only}

Hussain M, Tanaka TS, Greene JB, Mian S, Shtein RM. Long-term ocular surface outcomes and in vivo corneal confocal microscopy in patients with mechanical microkeratome vs femtosecond laser-assisted LASIK. Investigative Ophthalmology and Visual Science 2015;56(7):3912. CENTRAL

ISRCTN43661922 {published data only}

ISRCTN43661922. Comparison of dry eye syndrome and corneal sensation after femtosecond- and microkeratome-assisted LASIK. isrctn.com/ISRCTN43661922 (first received 28 February 2011). CENTRAL

Jia 2014 {published data only}

Jia BB, Zhang Y, Gao DM, Pang YZ. Changes of tear film after LASIK with corneal flap created by femtosecond laser and microkeratome. International Eye Science 2014;14(9):1730-2. CENTRAL

Jiang 2015 {published data only}

Jiang HS, Wu WH, Wang WW. Visual quality analysis of femtosecond LASIK and iris location guided mechanical SBK for high myopia. International Eye Science 2015;15(7):1168-71. CENTRAL

Kanellopoulos 2013 {published data only}

Kanellopoulos AJ, Asimellis G. Three-dimensional LASIK flap thickness variability: topographic central, paracentral and peripheral assessment, in flaps created by a mechanical microkeratome (M2) and two different femtosecond lasers (FS60 and FS200). Clinical Ophthalmology 2013;7:675-83. CENTRAL

Kasetsuwan 2016 {published data only}

Kasetsuwan N, Satitpitakul V, Puangsricharern V, Reinprayoon U, Pariyakanok L. Comparison of performances of femtosecond laser and microkeratome for thin-flap laser in situ keratomileusis. Lasers in Surgery and Medicine 2016;48(6):596-601. CENTRAL

Kezirian 2004 {published data only}

Kezirian GM, Stonecipher KG. Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in situ keratomileusis. Journal of Cataract and Refractive Surgery 2004;30(4):804-11. CENTRAL

Kostin 2012 {published data only}

Kostin OA, Rebrikov SV, Ovchinnikov AI, Stepanov AA. Corneal flap analysis after LASIK and femto-LASIK using optical coherence tomography and optical sections. Vestnik Oftalmologii 2012;128(5):3-5. CENTRAL

Kouassi 2012 {published data only}

Kouassi FX, Blaizeau M, Buestel C, Schweitzer C, Gallois A, Colin J, et al. Comparison of Lasik with femtosecond laser versus Lasik with mechanical microkeratome: predictability of flap depth, corneal biomechanical effects and optical aberrations. Journal Francais d'Ophtalmologie 2012;35(1):2-8. CENTRAL

Krueger 2007 {published data only}

Krueger RR, Dupps WJ Jr. Biomechanical effects of femtosecond and microkeratome-based flap creation: prospective contralateral examination of two patients. Journal of Refractive Surgery 2007;23(8):800-7. CENTRAL

Lee 2005 {published data only}

Lee HM, Koh A, Heng WJ, Fam HB. IntraLase femtosecond laser and hansatome microkeratome for LASIK: a comparative study. In: American Academy of Ophthalmology. 2005:240. CENTRAL

Lei 2016 {published data only}

Lei XH, Yu CT, Zhang Y, Li J, Ma M. Effect of laser in situ keratomileusis with femtosecond laser on visual quality. International Eye Science 2016;16(6):1120-3. CENTRAL

Li 2007 {published data only}

Li H, Sun T, Zhao J. Femtosecond laser vs. mechanical keratome in thin flap LASIK for correction of high myopia. In: American Academy of Ophthalmology. 2007:251. CENTRAL

Li 2010 {published data only}

Li H, Sun T, Wang M, Zhao J. Safety and effectiveness of thin-flap LASIK using a femtosecond laser and microkeratome in the correction of high myopia in Chinese patients. Journal of Refractive Surgery 2010;26(2):99-106. CENTRAL

Li 2012 {published data only}

Li FS, Zhang J, Yin HZ, Zhou YH. Comparison of LASIK flap thickness created with Ziemer LDV femtosecond laser and Moria M2 mechanical microkeratome. International Eye Science 2012;12(6):1056-8. CENTRAL

Lian 2013 {published data only}

Lian JC, Zhang SS, Zhang J, Ye S. Comparison of cornea flap made by femtosecond laser and microkeratome in laser in situ keratomileusis. Chung-Hua Yen Ko Tsa Chih 2013;49(4):305-8. CENTRAL

Lim 2006 {published data only}

Lim T, Yang S, Kim M, Tchah H. Comparison of the IntraLase femtosecond laser and mechanical microkeratome for laser in situ keratomileusis. American Journal of Ophthalmology 2006;141(5):833-9. CENTRAL

Lin 2012 {published data only}

Lin MY, Chang DC, Hsu WM, Wang IJ. Cox proportional hazards model of myopic regression for laser in situ keratomileusis flap creation with a femtosecond laser and with a mechanical microkeratome. Journal of Cataract and Refractive Surgery 2012;38(6):992-9. CENTRAL

Lin 2016 {published data only}

Lin MY, Chang DC, Shen YD, Lin YK, Lin CP, Wang IJ. Factors influencing intraocular pressure changes after laser in situ keratomileusis with flaps created by femtosecond laser or mechanical microkeratome. PloS One 2016;11(1):e0147699. CENTRAL

Mai 2012 {published data only}

Mai ZB, Liu SB, Nie XL, Tang XX, Xin BL. Comparative observation of confocal microscopy between femtosecond laser LASIK and Hansatome microkeratome LASIK. Zhonghua Shiyan Yanke Zazhi 2012;30(7):633-7. CENTRAL

Malhotra 2015 {published data only}

Malhotra C, Jain AK, Veluswami J, Ram J, Gupta R, Kumar P. Higher order aberrations and visual outcomes in wavefront-optimized sub-Bowman keratomileusis: flap creation using femtosecond laser versus mechanical microkeratome. Asia-Pacific Journal of Ophthalmology 2015;4(4):197-203. CENTRAL

Manche 2005 {published data only}

Manche EE. A prospective randomized eye-to-eye comparison: IntraLase vs. hansatome in myopic LASIK with CustomVue. In: American Academy of Ophthalmology. 2005:174. CENTRAL

McLaren 2007 {published data only}

McLaren JW, Patel SV, Nau CB, Winter EJ, Bourne WM. Corneal wavefront errors one year after LASIK: a paired comparison between flap cut with a femtosecond laser and with a mechanical microkeratome. Investigative Ophthalmology and Visual Science 2007;48:ARVO E – abstract 2360. CENTRAL

Medeiros 2007 {published data only}

Medeiros FW, Stapleton WM, Hammel J, Krueger RR, Netto MV, Wilson SE. Wavefront analysis comparison of LASIK outcomes with the femtosecond laser and mechanical microkeratomes. Journal of Refractive Surgery 2007;23(9):880-7. CENTRAL

Montés Micó 2007a {published data only}

Montés-Micó R, Rodríguez-Galietero A, Alió JL, Cerviño A. Contrast sensitivity after LASIK flap creation with a femtosecond laser and a mechanical microkeratome. Journal of Refractive Surgery 2007;23(2):188-92. CENTRAL

Montés Micó 2007b {published data only}

Montés-Micó R, Rodríguez-Galietero A, Alió JL. Femtosecond laser versus mechanical keratome LASIK for myopia. Ophthalmology 2007;114(1):62-8. CENTRAL

Muñoz 2010 {published data only}

Muñoz G, Albarrán-Diego C, Ferrer-Blasco T, García-Lázaro S, Cerviño-Expósito A. Long-term comparison of corneal aberration changes after laser in situ keratomileusis: mechanical microkeratome versus femtosecond laser flap creation. Journal of Cataract and Refractive Surgery 2010;36(11):1934-44. CENTRAL

Nau 2006 {published data only}

Nau CB, McLaren JW, Maguire LJ, Patel, SV, Bourne WM. Keratocyte density after LASIK: does cutting the flap with a femtosecond laser make a difference? Investigative Ophthalmology and Visual Science 2006;47:ARVO E – abstract 542. CENTRAL

Nau 2007 {published data only}

Nau CB, Patel SV, McLaren JW, Maguire LJ, Bourne WM. Central epithelial and flap thickness after LASIK: femtosecond laser vs. mechanical microkeratome. Investigative Ophthalmology and Visual Science2007;48:ARVO E – abstract 5329. CENTRAL

NCT03193411 {published data only}

NCT03193411. Visumax femtolasik versus moria M2 microkeratome in myopia. clinicaltrials.gov/ct2/show/NCT03193411 (first received 20 June 2017). CENTRAL

NCT03484468 {published data only}

NCT03484468. Femtosecond laser versus microkeratome in creating corneal flaps in LASIK. clinicaltrials.gov/ct2/show/NCT03484468 (first received 30 March 2018). CENTRAL

NCT03597906 {published data only}

NCT03597906. Topography guided LASIK by different protocols for treatment of astigmatism. clinicaltrials.gov/ct2/show/NCT03597906 (first received 24 July 2018). CENTRAL

Patel 2006 {published data only}

Patel SV, McLaren JW, Maguire LJ, Bourne WM. A randomized-controlled study of bladeless and microkeratome LASIK. Investigative Ophthalmology and Visual Science 2006;47:ARVO E – abstract 4331. CENTRAL

Patel 2008 {published data only}

Patel S, Alió JL, Artola A. Changes in the refractive index of the human corneal stroma during laser in situ keratomileusis. Effects of exposure time and method used to create the flap. Journal of Cataract and Refractive Surgery 2008;34(7):1077-82. CENTRAL

Rosa 2009 {published data only}

Rosa AM, Neto Murta J, Quadrado MJ, Tavares C, Lobo C, Van Velze R, et al. Femtosecond laser versus mechanical microkeratomes for flap creation in laser in situ keratomileusis and effect of postoperative measurement interval on estimated femtosecond flap thickness. Journal of Cataract and Refractive Surgery 2009;35(5):833-8. CENTRAL

Shetty 2012 {published data only}

Shetty R, Malhotra C, D'Souza S, Wadia K. WaveLight FS200 vs Hansatome LASIK: intraoperative determination of flap characteristics and predictability by hand-held bioptigen spectral domain ophthalmic imaging system. Journal of Refractive Surgery 2012;28(11 Suppl):S815-20. CENTRAL

Sonigo 2006 {published data only}

Sonigo B, Iordanidou V, Chong-Sit D, Auclin F, Ancel JM, Labbé A, et al. In vivo corneal confocal microscopy comparison of IntraLase femtosecond laser and mechanical microkeratome for laser in situ keratomileusis. Investigative Ophthalmology and Visual Science 2006;47(7):2803-11. CENTRAL

Torky 2017 {published data only}

Torky MA, Al Zafiri YA, Khattab AM, Farag RK, Awad EA. Visumax femtolasik versus Moria M2 microkeratome in mild to moderate myopia: efficacy, safety, predictability, aberrometric changes and flap thickness predictability. BMC Ophthalmology 2017;17(1):125. CENTRAL

von Jagow 2009 {published data only}

von Jagow B, Kohnen T. Corneal architecture of femtosecond laser and microkeratome flaps imaged by anterior segment optical coherence tomography. Journal of Cataract and Refractive Surgery 2009;35(1):35-41. CENTRAL

Xia 2015 {published data only}

Xia LK, Yu J, Chai GR, Wang D, Li Y. Comparison of the femtosecond laser and mechanical microkeratome for flap cutting in LASIK. International Journal of Ophthalmology 2015;8(4):784-90. CENTRAL

Xie 2014 {published data only}

Xie W, Zhang D, Chen J, Liu J, Yu Y, Hu L. Tear menisci after laser in situ keratomileusis with mechanical microkeratome and femtosecond laser. Investigative Ophthalmology and Visual Science 2014;55(9):5806-12. CENTRAL

Zhang 2011 {published data only}

Zhang ZH, Jin HY, Suo Y, Patel SV, Montés-Micó R, Manche EE, et al. Femtosecond laser versus mechanical microkeratome laser in situ keratomileusis for myopia: metaanalysis of randomized controlled trials. Journal of Cataract and Refractive Surgery 2011;37(12):2151-9. CENTRAL

Zhang 2012 {published data only}

Zhang F, Deng S, Guo N, Wang M, Sun X. Confocal comparison of corneal nerve regeneration and keratocyte reaction between FS-LASIK, OUP-SBK, and conventional LASIK. Investigative Ophthalmology and Visual Science 2012;53(9):5536-44. CENTRAL

Zhang 2013 {published data only}

Zhang Y, Chen YG, Xia YJ. Comparison of corneal flap morphology using AS-OCT in LASIK with the WaveLight FS200 femtosecond laser versus a mechanical microkeratome. Journal of Refractive Surgery 2013;29(5):320-4. CENTRAL

PACTR201708002498199 {published data only}

PACTR201708002498199. Mechanical versus femtolaser corneal flaps assessment. pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2498 (first received 3 August 2017). CENTRAL

Ang 2009

Ang EK, Couper T, Dirani M, Vajpayee RB, Baird PN. Outcomes of laser refractive surgery for myopia. Journal of Cataract and Refractive Surgery 2009;35(5):921-33.

Azar 2002

Azar DT, Koch D. LASIK (Laser in Situ Keratomileusis): Fundamentals, Surgical Techniques, and Complications. Boca Raton (FL): CRC Press, 2002.

Azar 2006

Azar DT, Gatinel D, Hoang-Xuan T. Refractive Surgery. 2nd edition. St Louis (MO): Elsevier Mosby, 2006.

Azar 2019

Azar DT. Refractive Surgery E-Book. Elsevier Health Sciences, 2019.

Bashir 2017

Bashir ZS, Ali MH, Anwar A, Ayub MH, Butt NH. Femto-LASIK: the recent innovation in laser assisted refractive surgery. Journal of the Pakistan Medical Association 2017;67(4):609-15.

Bower 2001

Bower KS, Weichel ED, Kim TJ. Overview of refractive surgery. American Family Physician 2001;64(7):1183-90.

Chaurasia 2010

Chaurasia SS, Luengo Gimeno F, Tan K, Yu S, Tan DT, Beuerman RW, et al. In vivo real-time intraocular pressure variations during LASIK flap creation. Investigative Ophthalmology and Visual Science 2010;51(9):4641-5.

Chen 2012

Chen S, Feng Y, Stojanovic A, Jankov MR 2nd, Wang Q. IntraLase femtosecond laser vs mechanical microkeratomes in LASIK for myopia: a systematic review and meta-analysis. Journal of Refractive Surgery 2012;28(1):15-24.

Corcoran 2015

Corcoran KJ. Macroeconomic landscape of refractive surgery in the United States. Current Opinion in Ophthalmology 2015;26(4):249-54.

Courtin 2015

Courtin R, Saad A, Guilbert E, Grise-Dulac A, Gatinel D. Opaque bubble layer risk factors in femtosecond laser-assisted LASIK. Journal of Refractive Surgery 2015;31(9):608-12.

Covidence [Computer program]

Veritas Health InnovationCovidence. Melbourne, Australia: Veritas Health Innovation, accessed after 13 December 2018.Available at covidence.org.

Farjo 2013

Farjo AA, Sugar A, Schallhorn SC, Majmudar PA, Tanzer DJ, Trattler WB, et al. Femtosecond lasers for LASIK flap creation: a report by the American Academy of Ophthalmology. Ophthalmology 2013;120(3):e5-20.

Flanagan 2003

Flanagan GW, Binder PS. Precision of flap measurements for laser in situ keratomileusis in 4428 eyes. Journal of Refractive Surgery 2003;19(2):113-23.

Gatinel 2013

Gatinel D, Saad A, Guilbert E, Rouger H. Unilateral rainbow glare after uncomplicated femto-LASIK using the FS-200 femtosecond laser. Journal of Refractive Surgery 2013;29(7):498-501.

Gil‐Cazorla 2011

Gil-Cazorla R, Teus MA, de Benito-Llopis L, Mikropoulos DG. Femtosecond laser vs mechanical microkeratome for hyperopic laser in situ keratomileusis. American Journal of Ophthalmology 2011;152(1):16-21.e2.

GRADEpro 2015 [Computer program]

McMaster University (developed by Evidence Prime)GRADEpro GDT. Version accessed 17 December 2018. Hamilton (ON): McMaster University (developed by Evidence Prime), 2015.Available at gradepro.org.

Higgins 2017

Higgins JP, Altman DG, Sterne JA, editor(s). Chapter 8: Assessing risk of bias in included studies. In: Higgins JP, Churchill R, Chandler J, Cumpston MS, editor(s). Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0 (updated June 2017). The Cochrane Collaboration, 2017. Available from www.training.cochrane.org/handbook.

Holden 2016

Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016;123(5):1036-42.

Huhtala 2016

Huhtala A, Pietilä J, Mäkinen P, Uusitalo H. Femtosecond lasers for laser in situ keratomileusis: a systematic review and meta-analysis. Clinical Ophthalmology 2016;10:393-404.

Issa 2011

Issa A, Al Hassany U. Femtosecond laser flap parameters and visual outcomes in laser in situ keratomileusis. Journal of Cataract and Refractive Surgery 2011;37(4):665-74.

Lubatschowski 2000

Lubatschowski H, Maatz G, Heisterkamp A, Hetzel U, Drommer W, Welling H, et al. Application of ultrashort laser pulses for intrastromal refractive surgery. Graefes Archive for Clinical and Experimental Ophthalmology 2000;238(1):33-9.

Medeiros 2011

Medeiros FW, Sinha-Roy A, Alves MR, Dupps WJ Jr. Biomechanical corneal changes induced by different flap thickness created by femtosecond laser. Clinics 2011;66(6):1067-71.

Moher 2009

Moher David, Liberati Alessandro, Tetzlaff Jennifer, Altman Douglas G. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009;339:b2535.

Morgan 2012

Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet 2012;379(9827):1739-48.

Moshirfar 2010

Moshirfar M, Gardiner JP, Schliesser JA, Espandar L, Feiz V, Mifflin MD, et al. Laser in situ keratomileusis flap complications using mechanical microkeratome versus femtosecond laser: retrospective comparison. Journal of Cataract and Refractive Surgery 2010;36(11):1925-33.

NASEM 2016

National Academies of Sciences, Engineering, Medicine, Teutsch SM, McCoy MA, Woodbury RB, Welp A, editor(s). Making Eye Health a Population Health Imperative: Vision for Tomorrow. Washington (DC): National Academies Press, 2016.

Randleman 2012

Randleman JB, Shah RD. LASIK interface complications: etiology, management, and outcomes. Journal of Refractive Surgery 2012;28(8):575-86.

Review Manager 2014 [Computer program]

Nordic Cochrane Centre, The Cochrane CollaborationReview Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Riordan‐Eva 2011

Riordan-Eva P. Chapter 21. Optics & refraction. In: Riordan-Eva P, Emmett CT, editors(s). Vaughan & Asbury's General Ophthalmology. 18th edition. New York (NY): McGraw-Hill Companies, 2011.

Sales 2016

Sales CS, Manche EE. Comparison of self-reported quality of vision outcomes after myopic LASIK with two femtosecond lasers: a prospective, eye-to-eye study. Clinical Ophthalmology 2016;10:1691-9.

Salomao 2010

Salomao MQ, Wilson SE. Femtosecond laser in laser in situ keratomileusis. Journal of Cataract and Refractive Surgery 2010;36(6):1024-32.

Smith 2009

Smith TS, Frick KD, Holden BA, Fricke TR, Naidoo KS. Potential lost productivity resulting from the global burden of uncorrected refractive error. Bulletin of the World Health Organization 2009;87(6):431-7.

Stonecipher 2006

Stonecipher KG, Dishler JG, Ignacio TS, Binder PS. Transient light sensitivity after femtosecond laser flap creation: clinical findings and management. Journal of Cataract and Refractive Surgery 2006;32(1):91-4.

Referencias de otras versiones publicadas de esta revisión

Ir a:

Kahuam‐López 2018

Kahuam-López N, Navas A, Castillo-Salgado C, Graue-Hernandez EO, Jimenez-Corona A, Ibarra A. Femtosecond laser versus mechanical microkeratome use for laser-assisted in-situ keratomileusis (LASIK). Cochrane Database of Systematic Reviews 2018, Issue 2. [DOI: 10.1002/14651858.CD012946]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Buzzonetti 2008

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: parallel group

Number randomly assigned: 47 eyes, 28 participants

Exclusions after randomization: not reported

Number analyzed: not reported

Unit of analysis: eye

Losses to follow‐up: not reported

Handling of missing data: not reported

Power calculation: "Given the expected difference between the mean aberration values of 20% and the expected SD from the mean value for each group of 20%, the sample size considered in this trial (n = 24 eyes in the mechanical microkeratome group and n = 23 eyes in femtosecond laser group) provided a power of 85% at a level of 0.02."

Study dates: June 2004 to November 2005

Participants

Country: Italy

Overall mean age: 38.7 years (SD 9.8)

Age range: not reported

Gender: not reported

Setting: Institute of Ophthalmology, Catholic University, Rome

Equivalence of baseline characteristics: yes

Inclusion criteria: people with spherical and spherocylindrical myopia, preoperative astigmatism value 2.00 D and mean spherical equivalent defect of –5.2 D (SD 3.3)

Exclusion criteria: not reported

Interventions

Laser for ablation: Bausch & Lomb Technolas 217 excimer laser

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: 160 μm thickness, 9.0 mm diameter, superior hinge

Number of people randomized: 24 eyes, 15 participants

Length of follow‐up:

Planned: not reported

Actual: 12 months

Intervention 2

Intervention: LASIK with an IntraLase femtosecond laser

Flap dimensions: 120 μm thickness, 9.0 mm diameter, and 50 degree, superior hinge angle

Number of people randomized: 23 eyes, 13 participants

Length of follow‐up:

Planned: not reported

Actual: 12 months

Outcomes

Mean UCVA after surgery

  • Intervals at which outcome assessed: 1 month

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: not reported

  • Instrument for measurement: not reported

BCVA after surgery

  • Intervals at which outcome assessed: 1 month

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: not reported

  • Instrument for measurement: not reported

Mean spherical equivalent of the refractive error after surgery

  • Intervals at which outcome assessed: 1 month

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: D

  • Instrument for measurement: not reported

Adverse events reported: no

Identification

Sponsorship source: IRCCS‐Casa Sollievo della Sofferenza Hospital ans Institue of Ophthalmology of Catholic University

Country: Italy

Setting: Institute of Ophthalmology

Comments: none

Author's name: Luca Buzzonetti

Institution: Ophthalmology Department, IRCCS–Casa Sollievo della Sofferenza Hospital, Institute of Ophthalmology, Catholic University

Email: lbuzzonetti@ tibernet.it

Address: Via Sabotino, 2‐00195 Rome, Italy

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "patients were randomly assigned to either the mechanical microkeratome or IntraLase."

Comment: randomization method not specified

Allocation concealment (selection bias)

Unclear risk

Comment: allocation concealment not specified

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: no clear description of the measures used to mask trial participants and personnel from knowledge of which intervention a participant received

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: no description of the measures used to mask outcome assessors from knowledge of which intervention a participant received

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Comment: unclear whether all participants randomized were also analyzed

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Durrie 2005

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 102 eyes, 51 participants

Exclusions after randomization: 0

Number analyzed: 102 eyes, 51 participants

Unit of analysis: eye

Losses to follow‐up: 0

Handling of missing data: no missing data

Power calculation: not reported

Study dates: July 2003 to August 2003

Participants

Country: USA

Overall mean age: 34.7 years (SD 7.7)

Age range: not reported

Gender: women 69%, men 31%

Setting: not reported

Equivalence of baseline characteristics: yes

Inclusion criteria: people with a manifest myopic refractive error up to 7.00 D sphere with < 0.50 D astigmatism in both eyes or aberrometer dilated refraction up to 7.50 D sphere with < 1.50 D astigmatism, age ≥ 21 years, a normal ophthalmic examination except for refractive error, normal topography, no history of ocular surgery, stable refraction within 60.50 D over the past year, no ongoing use of ophthalmic or systemic medications, and no history of autoimmune disease

Exclusion criteria: not reported

Interventions

Laser for ablation: LADARVision 4000

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: 180 μm thickness, 9.5 mm diameter, superior hinge

Number of people randomized: 51 eyes, 51 participants

Length of follow‐up:

Planned: not reported

Actual: 3 months

Intervention 2

Intervention: LASIK with an IntraLase femtosecond laser

Flap dimensions: 118 μm thickness, 9.5 mm diameter, and 55 degree superior hinge

Number of people randomized: 51 eyes, 51 participants

Length of follow‐up:

Planned: not reported

Actual: 3 months

Outcomes

Mean UCVA after surgery

  • Intervals at which outcome assessed: 1 day, 1 week, and 1 and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: logMAR

  • Instrument for measurement: Electronic Early Treatment of Diabetic Retinopathy trial testing protocol

Mean spherical equivalent of the refractive error after surgery

  • Intervals at which outcome assessed: 1 day, 1 week, and 1 month

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: D

  • Instrument for measurement: not reported

Proportion of eyes within ± 0.5 D of target refraction after surgery

  • Intervals at which outcome assessed: 1 day, 1 week, and 1 and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: D

  • Instrument for measurement: not reported

Adverse events reported: no

Identification

Sponsorship source: not reported

Country: USA

Setting: Institute of Ophthalmology

Comments: none

Author's name: Guy M Kezirian

Institution: SurgiVision Consultants, Inc.

Email: [email protected]

Address: 2183 Hathaway Avenue, Westlake Village, CA 91362‐5170

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The selection of the flap creation method was done at the time of enrollment using a predefined randomization schedule."

Allocation concealment (selection bias)

Unclear risk

Comment: method of concealment not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: trial did not address this risk of bias

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Clinical examinations were performed by optometrists trained in LASIK evaluations who were blinded to which eye had the femtosecond laser flap."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "All patients (51/51, 100%) appeared for the 1‐ and 3‐month visits."

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

High risk

Quote: "Dr. Durrie is a paid consultant to IntraLase Corporation and Alcon Laboratories, Inc. Dr. Kezirian received financial compensation from IntraLase Corporation for his assistance with data analysis and preparation of the manuscript"

Gui‐Hong 2018

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: parallel group

Number randomly assigned: 240 eyes, 120 participants

Exclusions after randomization: not reported

Number analyzed: 240 eyes, 120 participants

Unit of analysis: eye

Losses to follow‐up: not reported

Handling of missing data: not reported

Power calculation: not reported

Study dates: June 2014 to May 2015

Participants

Country: China

Overall mean age: 27.2 years (SD 3.2)

Age range: 19 to 44 years

Gender: women 54%, men 46%

Setting: not reported

Equivalence of baseline characteristics: yes

Inclusion criteria: people with myopia

Exclusion criteria: not reported

Interventions

Laser for ablation: not reported

Intervention 1

Intervention: LASIK with a microkeratome

Flap dimensions: not reported

Number of people randomized: 120 eyes, 60 participants

Length of follow‐up:

Planned: not reported

Actual: 6 months

Intervention 2

Intervention: LASIK with a femtosecond laser

Flap dimensions: not reported

Number of people randomized: 120 eyes, 60 participants

Length of follow‐up:

Planned: not reported

Actual: 6 months

Outcomes

Mean UCVA after surgery

  • Intervals at which outcome assessed: 1 week, and 1 and 6 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 6 months

  • Scale: logMAR

  • Instrument for measurement: not reported

Mean spherical equivalent of the refractive error after surgery

  • Intervals at which outcome assessed: 1 week, and 1 and 6 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 6 months

  • Scale: D

  • Instrument for measurement: not reported

Identification

Sponsorship source: not specified

Country: China

Setting: Institute of Ophthalmology

Comments: none

Author's name: Xiao – Hong Gu

Institution: Gu's Eye Hospital

Email: 3235745327@qq. com

Address: Luohe 462000, Henan Province, China

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Comment: method of sequence generation not described

Allocation concealment (selection bias)

Unclear risk

Comment: method of concealment not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: trial did not describe masking participants or trial personnel

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: trial did not describe masking of outcome assessors

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Comment: unclear whether all participants randomized were analyzed

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Hasimoto 2013

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 38 eyes, 19 participants

Exclusions after randomization: 6 eyes, 3 participants

Number analyzed: 32 eyes, 16 participants

Unit of analysis: eye

Losses to follow‐up: 0

Handling of missing data: eyes with missing data excluded from analysis

Power calculation: not reported

Study dates: July 2010 to September 2010

Participants

Country: Brazil

Overall mean age: not reported

Age range: not reported

Gender: not reported

Setting: refractive surgery service of the Eye Hospital of Paraná

Equivalence of baseline characteristics: baseline characteristics not reported

Inclusion criteria: myopia < 6.00 D, astigmatism < 3.00, and hyperopia < 5.00 D, stable refraction, corneal diameter < 11 mm, discontinuation of contact lens 7 days before the preoperative evaluation, BCVA of 20/20 in both eyes

Exclusion criteria: use of rigid gas permeable lens, dry eye and severe blepharitis, anterior segment abnormalities (cataract, corneal scar, neovascularization within 1 mm of the ablation area), recurrent corneal erosion, membrane disease severe basal, keratoconus or progressive or unstable myopia, corneal thickness resulting in < 250 μm in the residual bed, topography or preoperative aberrations (or both) indicating unfit eyes surgery for visual correction of LASIK, intraocular surgery, history of herpes keratitis, use of systemic corticosteroid, immunocompromised patients with significant atopic disease, connective tissue disease, diabetes mellitus, macular abnormalities, lactation, participation in other clinical trials

Interventions

Laser for ablation: WaveLight Allegretto Wave Eye­Q Laser

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: 160 μm thickness, 9.5 mm diameter, superior hinge

Number of people randomized: 19 eyes, 19 participants

Length of follow‐up:

Planned: not reported

Actual: 3 months

Intervention 2

Intervention: LASIK with a femto LDVTM Ziemer femtosecond laser

Flap dimensions: 110 μm thickness, 9.5 mm diameter, and superior hinge

Number of people randomized: 19 eyes, 19 participants

Length of follow‐up:

Planned: not reported

Actual: 3 months

Outcomes

Adverse events reported: yes

Diffuse lamellar keratitis

  • Intervals at which outcome assessed: 1 day, 1 week, 1 month, and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: not reported

  • Instrument for measurement: not reported

Identification

Sponsorship source: not specified

Country: Brazil

Setting: Institute of Ophthalmology

Comments: none

Author's name: Alexander Rodrigo Hasimoto

Institution: Hospital de Olhos do Paraná – HOP, Curitiba (PR)

Email: [email protected]

Address: Rua Benjamin Constant, 788 – Ponta Grossa (PR) – 84010‐380

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The choice of eye and surgical technique for inclusion followed a random order (through opaque envelopes)."

Allocation concealment (selection bias)

Low risk

Quote: "The choice of eye and surgical technique for inclusion followed a random order (through opaque envelopes enumerated by order of arrival of patients, containing two papers with the name of the technique to be used and another opaque envelope containing two papers with right eye and left eye for both to be drawn; once a surgical technique was defined for a given eye, the contralateral eye received the other technique)."

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "participants did not know which surgical technique they were receiving in each eye."

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "outcome assessor, had no prior knowledge of the surgical technique administered in each eye."

Incomplete outcome data (attrition bias)
All outcomes

High risk

Quote: "Of a total of 19 patients proposed for the trial, 3 patients (6 eyes) were discontinued because they had complications. One patient suffered blunt trauma to one eye in the 10th postoperative day. Immediately the patient underwent surgical intervention to reposition the flap. At the end of the third month, there was an uncorrected visual acuity of 20/16 in this eye. One patient had diffuse lamellar keratitis (DLK) in only one eye (femtosecond group) at the end of the third day. Surgical intervention was required, showing good evolution, with uncorrected visual acuity of 20/25 in this eye. And the last patient presented blood cells at the flap interface, which required flap washing, with good evolution and visual acuity without correction of 20/20 at the end of the trial. Thus, every trial was based on the evaluation of 16 patients."

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Manche_group 2008

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 102 eyes, 51 participants

Exclusions after randomization: 16 eyes, 8 participants

Number analyzed: 86 eyes, 43 participants

Unit of analysis: eye

Losses to follow‐up: 2 participants, 4 eyes

Handling of missing data: eyes with missing data excluded from analysis

Power calculation: not reported

Study dates: May 2004 to November 2005

Participants

Country: USA

Overall mean age: 39.7 years (SD 7.8)

Age range: 25 to 59 years

Gender: women 69%, men 31%

Setting: Department of Ophthalmology, Stanford University School of Medicine

Equivalence of baseline characteristics: yes

Inclusion criteria: people with no more than 6.00 D of spherical myopia, no more than 3.00 D of refractive astigmatism, stable refraction (0.50 D of sphere or cylinder), corneal diameter < 11.0 mm to allow for suction ring fixation, discontinuation of soft contact wear ≤ 7 days before the preoperative evaluation, visual acuity correctable to at least 20/20 in both eyes, age > 21 years, and ability to participate in follow‐up examinations for 12 months after LASIK

Exclusion criteria: rigid gas‐permeable contact lens use; severe dry eye; severe blepharitis; anterior segment abnormalities (i.e. cataracts, corneal scarring, or neovascularization within 1 mm of the intended ablation zone); recurrent corneal erosion; severe basement membrane disease; progressive or unstable myopia or keratoconus; unstable corneal mires on central keratometry results; corneal thickness in which the LASIK procedure could result in < 250 μm of remaining posterior corneal thickness below the flap postoperatively; baseline standard manifest refraction exhibiting > 0.75 D more minus in sphere power or a difference > 0.50 D in cylinder power, or a different type of astigmatism, i.e. 'with‐the‐rule', 'against‐the‐rule', or 'oblique' when the cylinder was > 0.50 D compared with the baseline standard cycloplegic refraction; preoperative assessment of ocular topography or aberrations (or both) indicating that either eye is not a suitable candidate for the LASIK vision correction procedure (i.e. forme fruste keratoconus, corneal warpage, or pellucid marginal degeneration); previous intraocular or corneal surgery; history of herpes zoster or herpes simplex virus keratitis; current use of systemic corticosteroid or immunosuppressive therapy; immunocompromise or clinically significant atopic disease; connective tissue disease; diabetes mellitus; steroid response; macular abnormality; pregnancy or lactation; sensitivity to the planned trial concomitant medications; or participation in another clinical trial of an ophthalmic drug or device

Interventions

Laser for ablation: Star S4Excimer Laser System

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: superiorly hinged, created using a 160 μm head and a 9.0 mm ring

Number of people randomized: 51 eyes, 51 participants

Length of follow‐up:

Planned: not reported

Actual: 12 months

Intervention 2

Intervention: LASIK with an IntraLase femtosecond laser

Flap dimensions: 120 μm thickness, 9.0 mm diameter, and superior hinge angle, degrees not reported

Number of people randomized: 51 eyes, 51 participants

Length of follow‐up:

Planned: not reported

Actual: 12 months

Outcomes

Mean spherical equivalent of the refractive error after surgery

  • Intervals at which outcome assessed: 12

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: D

  • Instrument for measurement: not reported

Proportion of eyes within ± 0.5 D of target refraction after surgery

  • Intervals at which outcome assessed: 12 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: D

  • Instrument for measurement: not reported

Adverse events reported: yes

Corneal haze

  • Intervals at which outcome assessed: < 1, 1, 3, 6, and 12 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: not reported

  • Instrument for measurement: not reported

Diffuse lamellar keratitis

  • Intervals at which outcome assessed: < 1, 1, 3, 6, and 12 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: not reported

  • Instrument for measurement: not reported

Epithelial ingrowth

  • Intervals at which outcome assessed: < 1, 1, 3, 6, and 12 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: not reported

  • Instrument for measurement: not reported

Dry eye

  • Intervals at which outcome assessed: 1, 3, 6, and 12 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 12 months

  • Scale: visual analog scale

  • Instrument for measurement: dry eye questionnaire

Identification

Sponsorship source: not reported

Country: USA

Setting: Institute of Ophthalmology

Comments: none

Author's name: Edward E Manche

Institution: Department of Ophthalmology, Stanford University School of Medicine

Email: [email protected]

Address: 900 Blake Wilbur Drive, Third Floor, Stanford, CA 94305

Notes

Trial registration number: NCT00691431

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomization was performed by assigning the dominant eye to one keratotomy method and the fellow eye to the other method according to a prepared randomization schedule."

Allocation concealment (selection bias)

Low risk

Quote: "envelope containing the assignment was opened."

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "The patient and the physician did not learn which eye
would be treated with which keratome until the day of surgery."

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: masking of outcome assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Four patients (5 eyes) discontinued the trial 6 months after surgery or later and required retreatment with good outcomes. Two patients (4 eyes) were lost to follow‐up. Because of the excimer laser software upgrade after the first 8 patients underwent LASIK, only the remaining 43 patients are included in the refractive outcomes and patient preference analyses to rule out any issues related to the initial version of excimer laser software."

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Patel_group 2010

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 42 eyes, 21 participants

Exclusions after randomization: 0

Number analyzed: 42 eyes

Unit of analysis: eye

Losses to follow‐up: 1 participant, 2 eyes

Handling of missing data: eyes with missing data excluded from analysis

Power calculation: "The trial was powered a priori to detect a difference of 0. 15 logMAR in UCVA or BCVA at 3 years after LASIK by assuming that the standard deviation of the difference in visual acuity would be 0.15 logMAR. This required a minimum sample size of 16 subjects ( 0.05/6, 0.20, paired test)."

Study dates: 2004 to 2005

Participants

Country: USA

Overall mean age: 41.5 years (SD 10)

Age range: 29 to 55 years

Gender: not reported

Setting: refractive surgery service at Mayo Clinic

Equivalence of baseline characteristics: yes

Inclusion criteria: people with myopia or myopic astigmatism (D not reported)

Exclusion criteria: any corneal abnormalities; a history of ocular disease, trauma, or surgery; or diabetes mellitus or other systemic disease known to affect the eye; or if they used ocular medications. Systemic medications were permitted unless they were known to affect the cornea or anterior segment.

Interventions

Laser for ablation: VISX Star S4 excimer laser

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: 160 μm thickness, 9.0 mm diameter, superior hinge

Number of people randomized: 21 eyes, 21 participants

Length of follow‐up:

Planned: not reported

Actual: 36 months

Intervention 2

Intervention: LASIK with an IntraLase femtosecond laser

Flap dimensions: 120 μm thickness, diameter not reported, and superior hinge, degrees not reported

Number of people randomized: 21 eyes, 21 participants

Length of follow‐up:

Planned: not reported

Actual: 36 months

Outcomes

Mean UCVA after surgery

  • Intervals at which outcome assessed: 1, 3, 6, 12 and 36 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 36 months

  • Scale: logMAR

  • Instrument for measurement: Electronic Early Treatment of Diabetic Retinopathy trial testing protocol

BCVA after surgery

  • Intervals at which outcome assessed: 1, 3, 6, 12 and 36 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 36 months

  • Scale: logMAR

  • Instrument for measurement: Electronic Early Treatment of Diabetic Retinopathy trial testing protocol

Proportion of eyes within ± 0.5 D of target refraction after surgery

  • Intervals at which outcome assessed: 1, 3, and 6 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 6 months

  • Scale: D

  • Instrument for measurement: not reported

Mean spherical equivalent of the refractive error after surgery

  • Intervals at which outcome assessed: 1, 3, 6, 12 and 36 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 36 months

  • Scale: D

  • Instrument for measurement: not reported

Sub‐basal nerve density

  • Intervals at which outcome assessed: 1, 3, 6, 12 and 36 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 36 months

  • Scale: ɥm/mm2

  • Instrument for measurement: ConfoScan 3 & 4 confocal microscope (Nidek Technologies, Greensboro, North Carolina)

Corneal sensitivity

  • Intervals at which outcome assessed: 1, 3, 6, 12 and 36 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 36 months

  • Scale: mL/min

  • Instrument for measurement: gas esthesiometer

Adverse events reported: no

Identification

Sponsorship source: National Institutes of Health, Bethesda, Maryland (Grant EY 02037; W.M.B.); Research to Prevent Blindness, Inc, New York, NY (S.V.P. as Olga Keith Wiess Special Scholar, and an unrestricted departmental grant); and Mayo Foundation, Rochester, MN

Country: USA

Setting: Institute of Ophthalmology

Comments: none

Author's name: Sanjay V Patel

Institution: Department of Ophthalmology, Mayo Clinic

Email: patel.sanjay @mayo.edu

Address: 200 First St SW, Rochester, MN 55905

Notes

Trial registration number: NCT00350246

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "patients were stratified by ocular dominance and then 1 eye of each patient was randomized to LASIK with the flap created by a femtosecond laser, and the other eye to LASIK with the flap created by a mechanical microkeratome."

Comment: random component in the sequence generation process not described

Allocation concealment (selection bias)

Unclear risk

Comment: concealment not described

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "It was not possible to mask patients as to which treatment was received in each eye."

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "The videokeratography maps of each cornea were examined by 1 masked observer, and the map with the most complete image and the smallest nondigitized areas was selected for assessment of wavefront errors from the anterior corneal surface."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "All subjects were included for analysis through 12 months of follow‐up after LASIK. After 1 year, 4 eyes of 2 patients required enhancement procedures for mild undercorrections, which were similar in the fellow eyes; data for these eyes were retained in the analysis at 36 months. Visual acuity and whole‐eye aberrometry data were excluded in both eyes of 1 patient at 36 months because of the presence of visually significant nuclear sclerotic cataracts; corneal topography data for this patient were included. One eye of 1 patient experienced trauma‐induced recurrent erosions between 13 and 22 months after surgery; no erosions occurred after that time and data for this eye were included at 36 months."

Selective reporting (reporting bias)

Unclear risk

Comment: some outcomes reported in the different reports of the trial were not prespecified in trial registration (www.clinicaltrials.gov/ct2/show/trial/NCT00350246)

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Salomão 2009

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 183 eyes, 183 participants

Exclusions after randomization: 0

Number analyzed: 183 eyes, 183 participants

Unit of analysis: eye

Losses to follow‐up: 0

Handling of missing data: no missing data

Power calculation: not reported

Study dates: 2005 to 2007

Participants

Country: USA

Overall mean age: 44 years (SD not reported)

Age range: 20 to 72 years

Gender: women 53.5%, men 46.5%

Setting: Cole Eye Institute, Cleveland, OH

Equivalence of baseline characteristics: yes

Inclusion criteria: people with low‐to‐moderate myopia with no symptoms or signs of dry eye before LASIK

Exclusion criteria: previous eye surgery, topical ocular medications before surgery, and other ocular conditions, such as ocular rosacea or chronic blepharitis

Interventions

Laser for ablation: Visx Star S4 IR or LADARWave 600

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: 180 μm thickness, 9.5 mm diameter, superior hinge

Number of people randomized: 70 eyes, 70 participants

Length of follow‐up:

Planned: not reported

Actual: 9 months

Intervention 2

Intervention: LASIK with an IntraLase FS femtosecond laser

Flap dimensions: 100 μm to 110 μm thickness, 9.0 mm to 9.3 mm diameter, and superior hinge

Number of people randomized: 113 eyes, 113 participants

Length of follow‐up:

Planned: not reported

Actual: 9 months

Outcomes

Adverse events reported: yes

Dry eye

  • Intervals at which outcome assessed: 1 day; 1 week; 1, 3, and 9 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 9 months

  • Scale: clinical grading scale

  • Instrument for measurement: slit lamp examination

Identification

Sponsorship source: United States Public Health Service grants EY010056 and EY015638 from the National Eye Institute, Bethesda, Maryland, and Research to Prevent Blindness, New York, NY, USA

Country: USA

Setting: Institute of Ophthalmology

Comments: none

Author's name: Steven E Wilson

Institution: Cole Eye Institute, I‐32, Cleveland Clinic

Email: [email protected]

Address: 9500 Euclid Avenue, Cleveland, OH 44195

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "One eye of each patient was randomly chosen for inclusion in the trial."

Comment: random component in the sequence generation not described

Allocation concealment (selection bias)

Unclear risk

Comment: trial did not address this risk of bias

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: trial did not address this risk of bias

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: trial did not address this risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: no missing outcome data

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Tan 2007

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 82 eyes, 41 participants

Exclusions after randomization: 0

Number analyzed: 82 eyes, 41 participants

Unit of analysis: eye

Losses to follow‐up: 0

Handling of missing data: no missing data

Power calculation: not reported

Study dates: not reported

Participants

Country: Singapore

Overall mean age: 31,4 (SD 5.3)

Age range: 21 to 42 years

Gender: women 82.9%, men 17.1%

Setting: The Eye Institute at Tan Tock Seng Hospital

Equivalence of baseline characteristics: Yes

Inclusion criteria: "All participants had not undergone any previous ocular surgery to either eye"

Exclusion criteria: "...were excluded from the trial if they had serious preexisting ocular pathology"

Interventions

Laser for ablation: Technolas Z100 Excimer laser

Intervention 1

Intervention: LASIK with a Zyoptix XP microkeratome

Flap dimensions: 120 μm thickness, 8.5 mm diameter, superior hinge

Number of people randomized: 41 eyes, 41 participants

Length of follow‐up:

Planned: not reported

Actual: 1 day

Intervention 2

Intervention: LASIK with a Intralase laser

Flap dimensions: 120 μm thickness, 8.5 mm diameter, superior hinge

Number of people randomized: 41 eyes, 41 participants

Length of follow‐up:

Planned: not reported

Actual: 1 day

Outcomes

Light perception

  • Intervals at which outcome assessed: during the procedure (suction, fashioning of flap)

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 day

  • Scale: Analog scale from 0 to 10

  • Instrument for measurement: standardized questionnaire (name or reference not reported)

Identification

Sponsorship source: not reported

Country: Singapore

Setting: Institute of Ophthalmology

Comments: none

Author's name: Hung‐Ming Lee

Institution: The Eye Institute, Tan Tock Seng Hospital

Email: [email protected]

Address: 11 Jalan Tan Tock Seng, Singapore 308433, Singapore

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Comment: random component in the sequence generation not described

Allocation concealment (selection bias)

Unclear risk

Comment: trial did not address this risk of bias

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: trial did not address this risk of bias

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: trial did not address this risk of bias

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Comment: no missing outcome data

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Tran 2005

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: within person

Number randomly assigned: 18 eyes, 9 participants

Exclusions after randomization: 1 eye, 1 participant

Number analyzed: 14 eyes, 7 participants

Unit of analysis: eye

Losses to follow‐up: 0 reported

Handling of missing data: not reported

Power calculation: not reported

Study dates: not reported

Participants

Country: USA

Overall mean age: 37 years (SD 9.5)

Age range: 23 to 50 years

Gender: women 23%, men 77%

Setting: private practice refractive surgery center, Irvine, CA

Equivalence of baseline characteristics: yes

Inclusion criteria: people with myopia or myopic astigmatism, visual acuity correctable to ≥ 20/40 in both eyes, stable refraction ≤ 4.00 D of spherical myopia, and no more than 2.00 D of refractive astigmatism in both eyes. Differences between fellow eyes had to be < 0.75 D in sphere and 0.50 D in cylinder.

Exclusion criteria: residual, recurrent, or active ocular disease; previous ocular surgery; corneal topographic or pachymetry (or both) findings suspicious for keratoconus; and systemic autoimmune, connective tissue, or atopic disease

Interventions

Laser for ablation: Technolas 217A

Intervention 1

Intervention: LASIK with a Hansatome microkeratome

Flap dimensions: 160 μm thickness, 9.5 mm diameter, superior hinge

Number of people randomized: 9 eyes, 9 participants

Length of follow‐up:

Planned: not reported

Actual: 3 months

Intervention 2

Intervention: LASIK with an IntraLase FS femtosecond laser

Flap dimensions: 120 μm thickness, 8.8 mm diameter, and 45 degree superior hinged

Number of people randomized: 9 eyes, 9 participants

Length of follow‐up:

Planned: not reported

Actual: 3 months

Outcomes

Adverse events reported: yes

Diffuse lamellar keratitis

  • Intervals at which outcome assessed: 1 day; 1 week; 1 and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: clinical grading scale

  • Instrument for measurement: slit lamp examination

Epithelial ingrowth

  • Intervals at which outcome assessed: 1 day, 1 week 1, and 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: 3 months

  • Scale: clinical grading scale

  • Instrument for measurement: slit lamp examination

Identification

Sponsorship source: IntraLase Corp

Country: USA

Setting: private practice refractive surgery center

Comments: none

Author's name: Dan B Tran

Institution: Coastal Vision Medical Group

Email: dr.tran@coastallaservision

Address: 709 East Anaheim Street, Long Beach, CA 90813, USA

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Each eye of each patient was randomized to receive mechanical (Hansatome)."

Comment: random component in the sequence generation not described

Allocation concealment (selection bias)

Unclear risk

Comment: method of concealment not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: masking of participants and trial personnel not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: masking of outcome assessors not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "One eye of 1 patient was mildly amblyopic (BSCVA 20/25). The postoperative manifest refraction showed a high degree of variability in the amblyopic eye. This patient was dropped from the analysis."

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

High risk

Quote: "Funded by IntraLase Corp., Irvine, California, USA. Drs. Tran, Sarayba, Bor, and Duh are paid consultants to IntraLase Corp, an industry directly related to one of the intervention groups evaluated.

Zhai 2013

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: parallel group

Number randomly assigned: 117 eyes, 60 participants

Exclusions after randomization: none

Number analyzed: 117 eyes, 60 participants

Unit of analysis: eye

Losses to follow‐up: not reported

Handling of missing data: not reported

Power calculation: not reported

Study dates: December 2011 to August 2012

Participants

Country: China

Overall mean age: 28.57 years (SD 4.83)

Age range: 24 to 47 years

Setting: Ophthalmic Center, Beijing Tongren Hospital

Equivalence of baseline characteristics: yes

Inclusion criteria: > 18 year old patients with myopia or myopic astigmatism, stable refraction for more than two years

Exclusion criteria: not reported

Interventions

Laser for ablation: not reported

Intervention 1

Intervention: LASIK with a M2 Moria Microkeratome

Flap dimensions: 110 μm thickness, 8.5 mm diameter, superior hinge

Number of people randomized: 58 eyes, 30 participants

Length of follow‐up:

Planned: not reported

Actual: 1 month

Intervention 2

Intervention: LASIK with Wavelight FS200 Femtosecond laser

Flap dimensions: 110 μm thickness, 8.7 mm diameter, superior hinge

Number of people randomized: 59 eyes, 30 participants

Length of follow‐up:

Planned: not reported

Actual: 1 month

Outcomes

Central corneal flap thickness

  • Intervals at which outcome assessed: 1 month

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 month

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Identification

Sponsorship source: not reported

Country: China

Setting: Institute of Ophthalmology

Comments: none

Author's name: Zhai Chang‐Bin

Institution: Ophthalmic Center, Beijing Tongren Hospital

Email: [email protected]

Address: Capital Medical University, Beijing 100730, China

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Comment: method of randomization not described

Allocation concealment (selection bias)

Unclear risk

Comment: method of concealment not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: masking of participants and trial personnel not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: masking of outcome assessors not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Comment: no missing outcome data

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias
Zhou 2012

Study characteristics

Methods

Study design: randomized controlled trial

Study grouping: parallel group

Number randomly assigned: 720 eyes, 360 participants

Exclusions after randomization:

Number analyzed: 720 eyes, 360 participants

Unit of analysis: eye

Losses to follow‐up: not reported

Handling of missing data: not reported

Power calculation: not reported

Study dates: December 2009 to July 2010

Participants

Country: China

Overall mean age: 25.91 years (SD 5.03)

Age range: not reported

Gender: not reported

Setting: Ophthalmic Center, Beijing Tongren Hospital, Capital Medical University

Equivalence of baseline characteristics: yes

Inclusion criteria: not reported

Exclusion criteria: patients with ocular pathologies such as keratoconus, corneal scars, corneal dystrophies, previous ocular surgery, glaucoma, diabetes, or other systemic diseases known to affect the eye were excluded

Interventions

Laser for ablation: Visx S4 excimer laser

Intervention 1

Intervention: LASIK with a M2 Moria Microkeratome

Flap dimensions: 110 μm thickness, 8.5 mm diameter, superior hinge

Number of people randomized: 360 eyes, 180 participants

Length of follow‐up:

Planned: not reported

Actual: 1 week

Intervention 2

Intervention: LASIK with an Ziemer LDV femtosecond laser

Flap dimensions: 110 μm thickness, 8.5 mm diameter, superior hinge

Number of people randomized: 360 eyes, 180 participants

Length of follow‐up:

Planned: not reported

Actual: 1 week

Outcomes

Central corneal flap thickness

  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Mean corneal flap thickness

  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Nasal and temporal flap thickness

  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Flap dimensions and regularity

  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Flap thickness accuracy

  • Intervals at which outcome assessed: 1 day, 3 days, and 1 week.

  • Planned follow‐up: not reported

  • Actual follow‐up: 1 week

  • Scale: μm

  • Instrument for measurement: RTVue OCT system

Identification

Sponsorship source: not reported

Country: China

Setting: Institute of Ophthalmology

Comments: none

Author's name: Yuehua Zhou

Institution: Ophthalmic Center, Beijing Tongren Hospital

Email: [email protected]

Address: No. 1 Dongjiaomin Ln, Dongchong District, Beijing, China 100730

Notes

Trial registration number: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Based on a randomization table, 180 patients were assigned to the Ziemer LDV (FS laser group) and 180 patients were assigned to the Moria M2 (microkeratome group) for bilateral LASIK"

Allocation concealment (selection bias)

Unclear risk

Comment: method of concealment not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: masking of participants and trial personnel not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: masking of outcome assessors not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Comment: no missing outcome data

Selective reporting (reporting bias)

Unclear risk

Comment: no published trial protocol with which to compare

Other bias

Low risk

Comment: trial appeared free of other sources of bias

BCVA: best corrected visual acuity; D: diopter; IOP: intraocular pressure; LASIK: laser‐assisted in‐situ keratomileusis; SD: standard deviation; UCVA: uncorrected visual acuity.

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

AlArfaj 2014

Non‐randomized trial

Alió 2008

Non‐randomized trial

Avetisov 2016

Non‐randomized trial

Brar 2008

Non‐randomized trial

Cañadas 2013

Non‐randomized trial

Cosar 2013

Non‐randomized study

Elmohamady 2018

Non‐randomized study

Erie 2006

Non‐randomized study

Grewal 2011

Non‐randomized study

Hamilton 2008

Non‐randomized study

He 2017

Non‐randomized study

Hosny 2013

Non‐randomized study

Hu 2015

Non‐randomized study

Hussain 2015

Non‐randomized study

ISRCTN43661922

Non‐randomized study

Jia 2014

Non‐randomized study

Jiang 2015

Non‐randomized study

Kanellopoulos 2013

Non‐randomized study

Kasetsuwan 2016

Non‐randomized study

Kezirian 2004

Non‐randomized study

Kostin 2012

Non‐randomized study

Kouassi 2012

Non‐randomized study

Krueger 2007

Non‐randomized study

Lee 2005

Non‐randomized study

Lei 2016

Non‐randomized study

Li 2007

Non‐randomized study

Li 2010

Non‐randomized study

Li 2012

Non‐randomized study

Lian 2013

Non‐randomized study

Lim 2006

Non‐randomized study

Lin 2012

Non‐randomized study

Lin 2016

Non‐randomized study

Mai 2012

Non‐randomized study

Malhotra 2015

Non‐randomized study

Manche 2005

Non‐randomized study

McLaren 2007

Non‐randomized study

Medeiros 2007

Non‐randomized study

Montés Micó 2007a

Non‐randomized study

Montés Micó 2007b

Non‐randomized study

Muñoz 2010

Non‐randomized study

Nau 2006

Non‐randomized study

Nau 2007

Non‐randomized study

NCT03193411

Non‐randomized study

NCT03484468

Non‐randomized study

NCT03597906

Not an intervention or comparator of interest

Patel 2006

Non‐randomized study

Patel 2008

Non‐randomized study

Rosa 2009

Non‐randomized study

Shetty 2012

Non‐randomized study

Sonigo 2006

Non‐randomized study

Torky 2017

Non‐randomized study

von Jagow 2009

Non‐randomized study

Xia 2015

Non‐randomized study

Xie 2014

Non‐randomized study

Zhang 2011

Non‐randomized study

Zhang 2012

Non‐randomized study

Zhang 2013

Non‐randomized study

Characteristics of ongoing studies [ordered by study ID]

Ir a:

PACTR201708002498199

Study name

Mechanical versus femtolaser corneal flaps assessment

Methods

Study design: randomized controlled trial

Study grouping: parallel group

Number randomly assigned: 160 eyes, 80 participants

Exclusions after randomization: not reported

Number analyzed: not reported

Unit of analysis: eye

Losses to follow‐up: not reported

Handling of missing data: not reported

Power calculation: not reported

Study dates: not reported

Participants

Country: Egypt

Overall mean age: not reported

Age range: 19 to 45 years

Gender: not reported

Setting: Tiba Eye Center

Equivalence of baseline characteristics: not reported

Inclusion criteria: "Myopic patients with refraction less than ‐6.00 D, astigmatism less than ‐3.00 D and a stable keratometry after cessation of soft contact lens wear for at least 2 weeks or rigid gas‐permeable contact lens wear for at least 4 weeks with K reading value ranging between 41.50 and 45.00 D".

Exclusion criteria: "Corneal pachymetry was < 520 μm at the thinnest location. Patients who do not fit the inclusion criteria or with history of herpetic eye disease, corneal dystrophy, corneal scarring because of infection or trauma, keratoconus, severe dry eye, collagen vascular disease, cataract, retinal disease, diabetes mellitus, pregnancy and who showed intraoperative and postoperative complications".

Interventions

Laser for ablation: not reported

Intervention 1

Intervention: LASIK with a Moria microkeratome

Flap dimensions: not reported

Number of people randomized: 80 eyes, 40 participants

Length of follow‐up:

Planned: not reported

Actual: not reported

Intervention 2

Intervention: LASIK with a femtosecond laser (commercial name not reported)

Flap dimensions: not reported

Number of people randomized: 80 eyes, 40 participants

Length of follow‐up: not reported

Planned: not reported

Actual: not reported

Outcomes

Corneal flap thickness

  • Intervals at which outcome assessed: 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: not reported

  • Scale: not reported

  • Instrument for measurement: not reported

Corneal flap symmetry

  • Intervals at which outcome assessed: 3 months

  • Planned follow‐up: not reported

  • Actual follow‐up: not reported

  • Scale: not reported

  • Instrument for measurement: not reported

Starting date

Contact information

Principal investigator: Abdel Rahman El Sebaey Sarhan

email: [email protected]

Notes

Trial registration number:PACTR201708002498199

D: diopter; LASIK: laser‐assisted in‐situ keratomileusis.

Data and analyses

Open in table viewer
Comparison 1. LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Mean uncorrected visual acuity after surgery Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only
Analysis 1.1
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 1: Mean uncorrected visual acuity after surgery

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 1: Mean uncorrected visual acuity after surgery

1.1.1 At 1 month

3

384

Mean Difference (IV, Random, 95% CI)

0.13 [‐0.08, 0.33]

1.1.2 At 3 months

2

144

Mean Difference (IV, Random, 95% CI)

0.00 [‐0.03, 0.03]

1.1.3 At 12 months

1

42

Mean Difference (IV, Random, 95% CI)

‐0.01 [‐0.06, 0.04]

1.2 Proportion of eyes within ± 0.5 diopters of target refraction after surgery Show forest plot

3

Risk Ratio (IV, Random, 95% CI)

Subtotals only
Analysis 1.2
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 2: Proportion of eyes within ± 0.5 diopters of target refraction after surgery

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 2: Proportion of eyes within ± 0.5 diopters of target refraction after surgery

1.2.1 At 1 month

2

144

Risk Ratio (IV, Random, 95% CI)

0.87 [0.77, 0.99]

1.2.2 At 12 months

1

79

Risk Ratio (IV, Random, 95% CI)

0.97 [0.85, 1.11]

1.3 Mean spherical equivalent of the refractive error after surgery Show forest plot

5

Mean Difference (IV, Random, 95% CI)

Subtotals only
Analysis 1.3
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 3: Mean spherical equivalent of the refractive error after surgery

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 3: Mean spherical equivalent of the refractive error after surgery

1.3.1 At 1 month

3

384

Mean Difference (IV, Random, 95% CI)

0.11 [‐0.18, 0.40]

1.3.2 At 12 months

3

168

Mean Difference (IV, Random, 95% CI)

0.09 [‐0.01, 0.19]

1.4 Corneal haze Show forest plot

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected
Analysis 1.4
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 4: Corneal haze

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 4: Corneal haze

1.4.1 Any time point

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected

1.5 Dry eye Show forest plot

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected
Analysis 1.5
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 5: Dry eye

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 5: Dry eye

1.5.1 Any time point

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected

1.6 Diffuse lamellar keratitis Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only
Analysis 1.6
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 6: Diffuse lamellar keratitis

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 6: Diffuse lamellar keratitis

1.6.1 Any time point

3

134

Risk Ratio (M‐H, Random, 95% CI)

0.27 [0.10, 0.78]

1.7 Epithelial ingrowth Show forest plot

2

Risk Ratio (IV, Random, 95% CI)

Subtotals only
Analysis 1.7
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 7: Epithelial ingrowth

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 7: Epithelial ingrowth

1.7.1 Any time point

2

102

Risk Ratio (IV, Random, 95% CI)

1.04 [0.11, 9.42]

1.8 Best corrected visual acuity after surgery Show forest plot

1

126

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]
Analysis 1.8
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 8: Best corrected visual acuity after surgery

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 8: Best corrected visual acuity after surgery

1.8.1 At 1 month

1

42

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.05, 0.05]

1.8.2 At 3 months

1

42

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.05, 0.05]

1.8.3 At 12 months

1

42

Mean Difference (IV, Fixed, 95% CI)

‐0.03 [‐0.09, 0.03]

Trial flow diagram.

Figuras y tablas -
Figure 1

Trial flow diagram.

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original image

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Figure 2
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Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included trials

Figuras y tablas -
Figure 3

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included trials

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.1 Mean uncorrected visual acuity after surgery [logMAR].

Figuras y tablas -
Figure 4

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.1 Mean uncorrected visual acuity after surgery [logMAR].

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.2 Proportion of eyes within ± 0.5 diopters of target refraction after surgery.

Figuras y tablas -
Figure 5

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.2 Proportion of eyes within ± 0.5 diopters of target refraction after surgery.

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.3 Mean spherical equivalent of the refractive error after surgery [diopters].

Figuras y tablas -
Figure 6

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.3 Mean spherical equivalent of the refractive error after surgery [diopters].

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.4 Corneal haze.

Figuras y tablas -
Figure 7

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.4 Corneal haze.

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.5 Dry eye.

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Figure 8

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.5 Dry eye.

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.6 Diffuse lamellar keratitis.

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Figure 9

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.6 Diffuse lamellar keratitis.

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Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.7 Epithelial ingrowth.

Figuras y tablas -
Figure 10

Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.7 Epithelial ingrowth.

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 1: Mean uncorrected visual acuity after surgery

Figuras y tablas -
Analysis 1.1

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 1: Mean uncorrected visual acuity after surgery

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 2: Proportion of eyes within ± 0.5 diopters of target refraction after surgery

Figuras y tablas -
Analysis 1.2

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 2: Proportion of eyes within ± 0.5 diopters of target refraction after surgery

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 3: Mean spherical equivalent of the refractive error after surgery

Figuras y tablas -
Analysis 1.3

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 3: Mean spherical equivalent of the refractive error after surgery

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 4: Corneal haze

Figuras y tablas -
Analysis 1.4

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 4: Corneal haze

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 5: Dry eye

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Analysis 1.5

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 5: Dry eye

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 6: Diffuse lamellar keratitis

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Analysis 1.6

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 6: Diffuse lamellar keratitis

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 7: Epithelial ingrowth

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Analysis 1.7

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 7: Epithelial ingrowth

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Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 8: Best corrected visual acuity after surgery

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Analysis 1.8

Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 8: Best corrected visual acuity after surgery

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Summary of findings 1. Laser‐assisted in‐situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism

Laser‐assisted in‐situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism

Patient or population: adults (18 years) with more than 0.5 diopters of myopia or myopic astigmatism
Setting: eye clinic
Intervention: LASIK with a mechanical microkeratome
Comparison: LASIK with a femtosecond laser

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Risk with LASIK with a femtosecond laser

Risk with LASIK with a mechanical microkeratome

Mean UCVA, 12 months after surgery (unit LogMAR)
Follow‐up: 1 day to 12 months

The mean uncorrected visual acuity after 12 months surgery in the LASIK with a femtosecond laser group was ‐0.04

MD 0.01 lower
(‐0.06 lower to 0.04 higher)

‐

42
(1 RCT)

⊕⊕⊝⊝
Lowa,b

Proportion of eyes within ± 0.5 diopters of target refraction, 12 months after surgery (unit diopters)
Follow‐up: 1 day to 12 months

925 per 1000

897 per 1000
(786 to 1000)

RR 0.97
(0.85 to 1.11)

79
(1 RCT)

⊕⊕⊝⊝
Lowa,b

Mean spherical equivalent of the refractive error, 12 months after surgery (unit diopters)
Follow‐up: 1 day to 12 months

The mean spherical equivalent of the refractive error 12 months after surgery

in the LASIK with a femtosecond laser group ranged from ‐0.30 to ‐0.31

MD 0.09 higher
(‐0.01 lower to 0.19 higher)

‐

168
(3 RCTs)

⊕⊕⊝⊝
Lowa,b

Corneal haze, any time point

23 per 1000

8 per 1000
(0 to 185)

RR 0.33
(0.01 to 7.96)

86
(1 RCT)

⊕⊝⊝⊝
Very lowb,c

Dry eye, any time point

80 per 1000

457 per 1000
(233 to 899)

RR 5.74
(2.92 to 11.29)

183
(1 RCT)

⊕⊕⊝⊝
Lowa,b

Diffuse lamellar keratitis, any time point

209 per 1000

56 per 1000
(21 to 163)

RR 0.27
(0.10 to 0.78)

134
(3 RCTs)

⊕⊕⊝⊝
Lowa,b

Epithelial ingrowth, any time point

20 per 1000

20 per 1000
(2 to 185)

RR 1.04
(0.11 to 9.42)

102
(2 RCTs)

⊕⊝⊝⊝
Very lowb,c

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; MD: mean difference; RCT: randomized controlled trial; RR: risk ratio; UCVA: uncorrected visual acuity.

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 one level due to imprecision.
bDowngraded one level due to risk of bias.
cDowngraded two levels due to very serious imprecision.

Figuras y tablas -
Summary of findings 1. Laser‐assisted in‐situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism
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Comparison 1. LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Mean uncorrected visual acuity after surgery Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1.1 At 1 month

3

384

Mean Difference (IV, Random, 95% CI)

0.13 [‐0.08, 0.33]

1.1.2 At 3 months

2

144

Mean Difference (IV, Random, 95% CI)

0.00 [‐0.03, 0.03]

1.1.3 At 12 months

1

42

Mean Difference (IV, Random, 95% CI)

‐0.01 [‐0.06, 0.04]

1.2 Proportion of eyes within ± 0.5 diopters of target refraction after surgery Show forest plot

3

Risk Ratio (IV, Random, 95% CI)

Subtotals only

1.2.1 At 1 month

2

144

Risk Ratio (IV, Random, 95% CI)

0.87 [0.77, 0.99]

1.2.2 At 12 months

1

79

Risk Ratio (IV, Random, 95% CI)

0.97 [0.85, 1.11]

1.3 Mean spherical equivalent of the refractive error after surgery Show forest plot

5

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.3.1 At 1 month

3

384

Mean Difference (IV, Random, 95% CI)

0.11 [‐0.18, 0.40]

1.3.2 At 12 months

3

168

Mean Difference (IV, Random, 95% CI)

0.09 [‐0.01, 0.19]

1.4 Corneal haze Show forest plot

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected

1.4.1 Any time point

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected

1.5 Dry eye Show forest plot

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected

1.5.1 Any time point

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected

1.6 Diffuse lamellar keratitis Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.6.1 Any time point

3

134

Risk Ratio (M‐H, Random, 95% CI)

0.27 [0.10, 0.78]

1.7 Epithelial ingrowth Show forest plot

2

Risk Ratio (IV, Random, 95% CI)

Subtotals only

1.7.1 Any time point

2

102

Risk Ratio (IV, Random, 95% CI)

1.04 [0.11, 9.42]

1.8 Best corrected visual acuity after surgery Show forest plot

1

126

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

1.8.1 At 1 month

1

42

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.05, 0.05]

1.8.2 At 3 months

1

42

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.05, 0.05]

1.8.3 At 12 months

1

42

Mean Difference (IV, Fixed, 95% CI)

‐0.03 [‐0.09, 0.03]
Figuras y tablas -
Comparison 1. LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser
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