Kalenak 1996.
Methods |
Study design: parallel group, randomized controlled trial Number randomized: 25 eyes of 25 participants Exclusions after randomization: none reported Number analyzed: 25 eyes of 25 participants Unit of analysis: participant (one study eye per participant) Handling of missing data: none reported Sample size calculation: not reported |
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Participants |
Country: USA Mean age: not reported Gender: not reported Inclusion criteria: glaucoma with inadequately controlled IOP; at least one previous glaucoma filtering operation Exclusion criteria: neovascular glaucoma Equivalence of baseline characteristics: not reported Diagnoses in participants: non‐neovascular glaucoma |
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Interventions |
MMC group (n = 12): single‐plate Molteno implant with MMC (0.2 mg/mL) No MMC group (n = 13): single‐plate Molteno implant with placebo for 5 minutes |
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Outcomes |
Outcomes (primary and secondary outcomes not differentiated): mean IOP; surgical success, defined as IOP between 6 and 21 mmHg Length of follow‐up: "6 months or more, or to a defined endpoint" |
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Notes |
Study period: not reported Trial registration: not reported Funding and conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and personnel not reported |
Masking of outcome assessment (detection bias) | Unclear risk | Masking of outcome assessors not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data not reported |
Selective reporting (reporting bias) | High risk | No full‐length paper published more than 20 years after presenting the trial at a conference |
Other bias | Low risk | None identified |