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. Author manuscript; available in PMC: 2018 May 9.
Published in final edited form as: Cochrane Database Syst Rev. 2016 Aug 15;(8):CD011693. doi: 10.1002/14651858.CD011693.pub2
Mandatory items Optional items

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