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. 2018 May 14;2018(5):CD013029. doi: 10.1002/14651858.CD013029
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