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 eyes · 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 Equivalence of baseline characteristics (Y/N) |
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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, 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 this group · Drug (or intervention) name · Dose · Frequency · Route of administration |
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Outcomes | ||
Primary and secondary outcomes as defined in study reports See MECIR R70 |
List outcomes Adverse effects reported (Y/N) Length of follow‐up and intervals at which outcomes assessed |
Planned/actual length of follow‐up |
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? |
Sources of funding | ||
Declaration of interest See MECIR 69 |