Costa 2004.
Methods |
Study design: parallel group, randomized controlled trial Number randomized: 60 eyes of 60 participants Exclusions after randomization: 28 eyes of 28 participants lost to follow‐up at 12 months Number analyzed: 32 eyes of 32 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: Brazil, Canada, Scotland, USA Mean age: 62 years Gender: 36 (60%) men and 24 (40%) women Inclusion criteria: uncontrolled glaucoma requiring glaucoma drainage device implantation Exclusion criteria: younger than 18 years of age; learning difficulties; mental illness; dementia; unconsciousness or severe illness Equivalence of baseline characteristics: age, race, lens status, prior glaucoma surgery and IOP similar in the two groups at baseline Diagnoses in participants: primary open‐angle glaucoma; neovascular glaucoma; congenital glaucoma; traumatic glaucoma; inflammatory and steroid‐induced glaucoma; glaucoma following penetrating keratoplasty; aphakic glaucoma |
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Interventions |
MMC group (n = 34): Ahmed valve implant with 0.5 mg/mL solution of MMC placed on the epislcera, under the conjunctiva and Tenon's capsule at the site for implant plate for 5 minutes No MMC group (n = 26): Ahmed valve implant with topical application of BSS using a soaked sponge on the episclera at site for implant plate for 5 minutes |
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Outcomes |
Outcomes (primary and secondary outcomes not differentiated): mean IOP; surgical success, defined as 1) postoperative IOP between 6 and 21 mmHg with or without anti‐glaucoma medications or 2) IOP reduction of at least 30% relative to preoperative values; best‐corrected visual acuity; number of anti‐glaucoma medications; complications Length of follow‐up: postoperative day 1, weeks 1 and 2, months 1, 3, 6, 12, and 18 |
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Notes |
Study period: not reported Trial registration: not reported Funding and conflicts of interest: "The authors have no commercial interest in the products mentioned in the text". |
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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 | High risk | 28/60 (47%) participants did not complete one year of follow‐up. |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registry record available to compare outcomes |
Other bias | Low risk | None identified |