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Photobiomodulation for non‐exudative age‐related macular degeneration

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Appendices

Appendix 1. CENTRAL search strategy

#1 MeSH descriptor: [Macular Degeneration] explode all trees
#2 MeSH descriptor: [Retinal Degeneration] explode all trees
#3 MeSH descriptor: [Retinal Neovascularization] explode all trees
#4 MeSH descriptor: [Choroidal Neovascularization] explode all trees
#5 MeSH descriptor: [Macula Lutea] explode all trees
#6 macula* near lutea*
#7 (macula* or retina* or choroid*) near/4 degenerat*
#8 (macula* or retina* or choroid*) near/4 neovascul*
#9 AMD or ARMD or maculopath*
#10 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9
#11 MeSH descriptor: [Low‐Level Light Therapy] this term only
#12 (low near/2 level near/2 light)
#13 (low near/2 level near/2 laser*)
#14 (low near/2 power near/2 laser*)
#15 (low near/2 energy near/2 laser*)
#16 (low near/2 intensity near/2 laser*)
#17 (light near/2 based near/2 technolog*)
#18 light emitting diode*
#19 (LLLT or LLL or LED‐T)
#20 (photobiomodulat* or PBM or photomodulat*)
#21 (Gentlewaves or LT‐300)
#22 laser* near/2 (irradiat* or phototherap* or biostimulat*)
#23 (phototherap* near/2 infrared)
#24#11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23
#25#10 and #24

Appendix 2. MEDLINE Ovid search strategy

1. randomized controlled trial.pt.
2. (randomized or randomised).ab,ti.
3. placebo.ab,ti.
4. dt.fs.
5. randomly.ab,ti.
6. trial.ab,ti.
7. groups.ab,ti.
8. or/1‐7
9. exp animals/
10. exp humans/
11. 9 not (9 and 10)
12. 8 not 11
13. exp retinal degeneration/
14. retinal neovascularization/
15. choroidal neovascularization/
16. exp macula lutea/
17. (macula$ adj2 lutea).tw.
18. ((macul$ or retina$ or choroid$) adj4 degener$).tw.
19. ((macul$ or retina$ or choroid$) adj4 neovasc$).tw.
20. (AMD or ARMD or CNV).tw.
21. maculopath$.tw.
22. or/13‐21
23. Low‐Level Light Therapy/
24. (low adj2 level adj2 light).tw.
25. (low adj2 level adj2 laser$).tw.
26. (low adj2 power adj2 laser$).tw.
27. (low adj2 energy adj2 laser$).tw.
28. (low adj2 intensity adj2 laser$).tw.
29. (light adj2 based adj2 technolog$).tw.
30. light emitting diode$.tw.
31. (LLLT or LLL or LED‐T).tw.
32. (photobiomodulat$ or PBM or photomodulat$).tw.
33. (Gentlewaves or LT‐300).tw.
34. (laser$ adj2 (irradiat$ or phototherap$ or biostimulat$)).tw.
35. (phototherap$ adj2 infrared).tw.
36. or/23‐35
37. 22 and 36
38. 12 and 37

The search filter for trials at the beginning of the MEDLINE strategy is from the published paper by Glanville 2006.

Appendix 3. Embase Ovid search strategy

1. exp randomized controlled trial/
2. exp randomization/
3. exp double blind procedure/
4. exp single blind procedure/
5. random$.tw.
6. or/1‐5
7. (animal or animal experiment).sh.
8. human.sh.
9. 7 and 8
10. 7 not 9
11. 6 not 10
12. exp clinical trial/
13. (clin$ adj3 trial$).tw.
14. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw.
15. exp placebo/
16. placebo$.tw.
17. random$.tw.
18. exp experimental design/
19. exp crossover procedure/
20. exp control group/
21. exp latin square design/
22. or/12‐21
23. 22 not 10
24. 23 not 11
25. exp comparative study/
26. exp evaluation/
27. exp prospective study/
28. (control$ or prospectiv$ or volunteer$).tw.
29. or/25‐28
30. 29 not 10
31. 30 not (11 or 23)
32. 11 or 24 or 31
33. exp retina macula degeneration/
34. exp retina degeneration/
35. exp retina neovascularization/
36. exp subretinal neovascularization/
37. (AMD or ARMD or CNV).tw.
38. ((macul$ or retina$ or choroid$) adj4 degener$).tw.
39. ((macul$ or retina$ or choroid$) adj4 neovasc$).tw.
40. exp retina macula lutea/
41. (macula$ adj2 lutea$).tw.
42. maculopath$.tw.
43. or/33‐42
44. low level laser therapy/
45. light emitting diode/
46. (low adj2 level adj2 light).tw.
47. (low adj2 level adj2 laser$).tw.
48. (low adj2 power adj2 laser$).tw.
49. (low adj2 energy adj2 laser$).tw.
50. (low adj2 intensity adj2 laser$).tw.
51. (light adj2 based adj2 technolog$).tw.
52. light emitting diode$.tw.
53. (LLLT or LLL or LED‐T).tw.
54. (photobiomodulat$ or PBM or photomodulat$).tw.
55. (Gentlewaves or LT‐300).tw.
56. (laser$ adj2 (irradiat$ or phototherap$ or biostimulat$)).tw.
57. (phototherap$ adj2 infrared).tw.
58. or/44‐57
59. 43 and 58
60. 32 and 59

Appendix 4. ISRCTN search strategy

(Condition: Macular Degeneration OR AMD OR ARMD OR CNV AND Interventions: photobiomodulation OR low level light OR low level laser)

Appendix 5. ClinicalTrials.gov search strategy

Interventional Studies | Macular Degeneration OR AMD OR ARMD OR CNV | photobiomodulation OR low light OR low laser

Appendix 6. WHO ICTRP search strategy

Condition = Macular Degeneration OR AMD OR ARMD OR CNV AND Interventions = photobiomodulation OR low level light OR low level laser

Appendix 7. Data on study characteristics

Mandatory items

Optional items

Methods

Study design

· Parallel group RCTi.e. people randomised to treatment

· Within‐person RCTi.e. eyes randomised to treatment

· Cluster RCTi.e. communities randomised to treatment

· Cross‐over RCT

· Other, specify

Exclusions after randomisation

Losses to follow up

Number randomised/analysed

How were missing data handled? e.g., available case analysis, imputation methods

Reported power calculation (Y/N), if yes, sample size and power

Unusual study design/issues

Eyes or

Unit of randomisation/ unit of analysis

· One eye included in study, specify how eye selected

· Two eyes included in study, both eyes received same treatment, briefly specify how analysed (best/worst/average/both and adjusted for within person correlation/both and not adjusted for within person correlation) and specify if mixture one eye and two eye

· Two eyes included in study, eyes received different treatments,specify if correct pair‐matched analysis done

Participants

Country

Setting

Ethnic group

Participation rate

Equivalence of baseline characteristics (Y/N)

Diagnostic criteria

Total number of participants

This information should be collected for total study population recruited into the study. If these data are only reported for the people who were followed up only, please indicate.

Number (%) of men and women

Average age and age range

Inclusion criteria

Exclusion criteria

Interventions

Intervention (n = )

Comparator (n = )

See MECIR 65 and 70

· Number of people randomised to each group

· Wavelength of photobiomodulation therapy

· Dose, fluence, intensity, coverage, treatment time

· Frequency, intervals and total number of sessions

· Route of administration

· Specify whether another intervention was performed at same time as intervention

Outcomes

Primary and secondary outcomes as defined in study reports

See MECIR R70

· Best corrected visual acuity at 12 months

· Contrast sensitivity

· Near visual acuity

· Reading speed

· Low luminance deficit score

· Quality of life score

· Cost benefit data (if available)

· The proportion of participants with worse vision following photobiomodulation therapy. Worse vision is defined by a loss of 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

· The proportion of participants who developed new geographic atrophy or progression of geographic atrophy.

· The proportion of participants who developed neovascular macular degeneration.

Planned/actual length of follow up

· Length of follow up

· Loss to follow up

· Intervals at which outcomes assessed

Notes

Date conducted

Specify dates of recruitment of participants mm/yr to mm/yr

Full study name: (if applicable)

Reported subgroup analyses (Y/N)

Were trial investigators contacted?

Trial Registration Number: (if applicable)

Sources of funding

Declaration of interest

See MECIR 69