Methods |
|
|
|
Study design |
Parallel group RCT
i.e. people randomized to treatment
Within-person RCT
i.e. eyes randomized to treatment
Cluster RCT
i.e. communities randomized to treatment
Cross-over RCT
Other, specify
|
Number of study arms Method of randomization Exclusions after randomization Losses to follow up Number randomized/analyzed Method of masking 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 |
One eye included in study, specify how eye selected
Two eyes included in study, both eyes received same treatment, briefly specify how analyzed (best/worst/average/both and adjusted for within person correlation/both and not adjusted for within person correlation) and specify if mixture of one eye and two eyes
Two eyes included in study, eyes received different treatments,
specify if correct pair-matched analysis done
|
Unit of randomization/unit of analysis |
|
Participants |
|
|
|
Country |
|
Setting Ethnic group Method of recruitment |
|
Total number of participants |
This information should be collected for total study population recruited into the study. If these data are reported for the people who were followed up only, please indicate. |
|
|
Number (%) of men and women |
Number (%) of men and women |
|
|
Average age and age range |
Average age and age range |
Inclusion criteria |
|
|
Exclusion criteria |
|
|
Interventions |
|
|
|
Intervention (n=) |
Number of people randomized to this group
Intervention name
Comparator name
Specify whether phacoemulsification, or other intervention, performed at same time as intervention
|
iStent or iStent inject surgical parameters, e. g. degrees of meshwork ablated, electrosurgical power Comparator parameters, e.g. dosage of drugs
|
Comparator (n=) |
See MECIR 65 and 70 |
|
Outcomes |
|
|
|
Primary and secondary outcomes as defined in study reports
|
Proportion of participants who are dropfree at 2 years follow-up
Mean change in number of IOP-lowering drops taken per day from baseline to 2 years follow-up
Mean change in IOP from baseline to 2 years follow-up
Health-related quality of life measures at 2 years follow-up
Intraoperative complications Adverse events reported (Y/N)
|
Planned/actual length of follow-up |
See MECIR R70 |
|
Notes |
|
|
|
Date conducted |
Specify dates of recruitment of participants mm/yr to mm/yr |
Full study name: (if applicable) Date of publication Reported subgroup analyses (Y/N) Were trial investigators contacted? |
|
Sources of funding |
|
|
Declaration of interest |
|
See MECIR 69 |
|