Gimbel 1995.
Methods |
Study design: parallel‐group RCT Unit of randomization: the individual (one eye per participant) Number randomized: 106 total; 53 eyes of 53 participants in combined surgery group and 53 eyes of 53 participants in cataract surgery alone group Unit of analysis: the individual (one eye per participant) Number analyzed: 102 total; 51 eyes of 51 participants in combined surgery group and 51 eyes of 51 participants in cataract surgery alone group Exclusions and losses to follow‐up: 4 participants; 2 in each group Power calculation: none reported |
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Participants |
Country: Canada (one site), South Africa (two sites) Age (mean ± SD): 75.5 years in combined surgery group; 77.5 years in cataract surgery alone group (SDs not reported) Gender: not reported Ethnicity: not reported Inclusion criteria:
Exclusion criteria:
Equivalence of baseline characteristics: yes (preoperative IOP), no (percentage of participants who used beta blockers) Diagnoses in participants: POAG or ocular hypertension and cataract; participants with pigment dispersion or pseudoexfoliation glaucoma also included |
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Interventions |
Intervention 1: combined cataract surgery (phacoemulsification) with IOL implantation and trabecular aspiration (trabeculotomy ab externo) Intervention 2: cataract surgery (phacoemulsification) with IOL implantation alone Study follow‐up: 24 months |
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Outcomes |
Primary outcomes: mean IOP and mean change in IOP Secondary outcomes: complications, number of glaucoma medications Adverse events reported: yes Intervals at which outcomes assessed: 1 day, and 3, 6, 12, and 24 months after surgery |
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Notes |
Type of study: published Study period: not reported Funding source: not reported Disclosures of interest: "None of the authors has a proprietary interest in the development or marketing of this technique or in any of the instruments or drugs described in this paper." Publication language: English Subgroup analysis: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Masking (detection bias) | High risk | "the physician following the patient was not masked as to whether the patient was in the study or control group" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 of 106 (4%) participants excluded from analysis: 2/53 in combined surgery group and 2/53 in cataract surgery alone group |
Selective reporting (reporting bias) | Low risk | Results for outcomes described in Methods section of study publication reported |
Other bias | Low risk | None identified |