Birt 1998.
Methods |
Study design: parallel‐group randomized controlled trial Number randomized: 43 eyes of 43 participants total; 11 participants in trabeculectomy + MMC + Gelfilm® (Pfizer) group; 7 participants in trabeculectomy + MMC group; 11 participants in trabeculectomy + Gelfilm® (Pfizer) group; 14 participants in trabeculectomy group Exclusions after randomization: none reported Losses to follow‐up: none reported Unit of analysis: individual (1 eye per participant) Number analyzed: 43 participants total; 11 participants in trabeculectomy + MMC + Gelfilm® (Pfizer) group; 7 participants in trabeculectomy + MMC group; 11 participants in trabeculectomy + Gelfilm® (Pfizer) group; 14 participants in trabeculectomy group How were missing data handled?: no missing data Power calculation: not reported |
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Participants |
Country: not reported
Mean age: not reported
Gender: not reported
Inclusion criteria: not reported
Exclusion criteria: not reported Equivalence of baseline characteristics: not reported |
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Interventions |
Intervention 1: trabeculectomy + MMC + Gelfilm® (Pfizer)
Intervention 2: trabeculectomy + MMC
Intervention 3: trabeculectomy + Gelfilm® (Pfizer)
Intervention 4: trabeculectomy Length of follow‐up: Planned: not reported Actual: 1 year |
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Outcomes | Primary and secondary outcomes not distinguished Outcomes, as reported: postoperative IOP, use of postoperative 5‐FU, and complications Intervals at which outcomes assessed: 1 year |
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Notes |
Publication type: published abstract Funding sources: not reported Disclosures of interest: not reported Trial registry: not registered Study period: not reported Subgroup analyses: none reported Publication language: English Attempted to contact author, but unable to find contact information in abstract |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generation was not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and personnel was not reported |
Masking of outcome assessment (detection bias) | High risk | Outcome assessors not masked as devices can be seen during eye examination |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed 1‐year follow‐up |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available and the authors did not define which outcomes and complications they were going to report |
Other bias | Unclear risk | Did not report source of funding or conflict of interest The abstract did not have enough information |