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 |
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Participants | ||
Country | Setting Ethnic group Participation rate Equivalence of baseline characteristics (Y/N) Diagnostic criteria |
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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 |
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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 |