Cantor 1998.
| Methods |
Study design: parallel group, randomized controlled trial Number randomized: 25 eyes of 25 participants Exclusions after randomization: 4 eyes of 4 participants lost to follow‐up at 12 months Number analyzed: 21 eyes of 21 participants at 12 months Unit of analysis: participant (one study eye per participant) Handling of missing data: participants lost to follow‐up were excluded from the analysis Sample size calculation: not reported |
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| Participants |
Country: USA Mean age: 67 years Gender: 12 (48%) men and 13 (52%) women Inclusion criteria: age 21 years or older; any race; either sex; any lens status; primary open‐angle glaucoma; pigment dispersion glaucoma; pseudoexfoliation glaucoma; primary angle‐closure glaucoma; neovascular glaucoma; traumatic glaucoma; any secondary open or angle‐closure glaucoma; congenital glaucoma; inflammatory glaucoma; any previous ocular surgery other than scleral buckling Exclusion criteria: previous aqueous implant shunt placement; previous scleral encircling band placement; pregnancy or lactation Equivalence of baseline characteristics: mean IOP at baseline was higher in the Molteno implant with MMC group (41.54 mmHg) than in the control group (34.65 mmHg); 3 black participants in the control group versus none in the MMC group Diagnoses in participants: neovascular glaucoma; chronic angle‐closure glaucoma; primary open‐angle glaucoma; aphakic glaucoma; glaucoma secondary to trauma |
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| Interventions |
MMC group (n = 12): pressure‐ridge, double‐plate Molteno implant with topical MMC (0.4 mg/mL applied for 2 minutes with a sponge soaked in the solution) No MMC group (n = 13): pressure‐ridge, double‐plate Molteno implant with BSS stained with gentian violet All participants in both groups received scleral patch grafts; postoperative management included 1% prednisolone acetate and gentamicin four times a day, 1% atropine 2 to 4 times a day and glaucoma medications (except for carbonic anhydrase inhibitors) in the fellow eye, as required. |
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| Outcomes |
Outcomes (primary and secondary outcomes not differentiated): mean IOP; visual acuity; number of postoperative medications; complications Length of follow‐up: postoperative week 1, months 1, 3, 6, and 12 |
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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) | Low risk | Quote: "The surgeon remained masked to which solution was being used." BSS used as placebo |
| Masking of outcome assessment (detection bias) | Unclear risk | Masking of outcome assessors not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Investigators reported 16% of data was missing, with equal duration of follow‐up in both groups and no obvious reasons why loss to follow‐up should be related to outcome. |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trial registry record available to compare outcomes |
| Other bias | Low risk | None identified |