Metcalfe 1989.
Methods |
Study design: prospective, randomized, double‐masked, parallel‐group RCT Country: UK Number randomized: Total: 100 Per group: acetazolamide = 50; placebo = 50 Exclusions after randomization: N/A Number analyzed: Total: 100 Per group: acetazolamide = 50; placebo = 50 Unit of analysis (participants vs eyes): eyes, 1 eye per participant, chosen if that eye needed laser. If both eyes were lasered, the first eye was chosen for inclusion. Losses to follow‐up: N/A How was missing data handled?: not reported Reported power calculation: no Unusual study design?: no |
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Participants |
Age (mean ± SD; years): acetazolamide = 74.0 ± 6.0, placebo = 74.6 ± 5.9 Females: acetazolamide = 54%, placebo = 52%, overall = 53% Inclusion criteria: uncontrolled OAG with IOP > 21 mmHg and progressive visual field loss, on maximum tolerated topical therapy, no previous LTP Exclusion criteria: already receiving acetazolamide Equivalence of baseline characteristics: yes |
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Interventions |
Intervention 1: acetazolamide (2 × 250 mg tablets), 1 hour prior to LTP Intervention 2: placebo (2 placebo tablets), 1 hour prior to LTP Length of follow‐up: Planned: 2 months Actual: 2 months |
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Outcomes |
Primary outcomes: IOP in both eyes, degree of anterior segment inflammation Secondary outcomes: not reported Adverse events reported: no Intervals at which outcomes assessed: 30 min; 1, 2, 3, 24 hours; 2 months after laser treatment |
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Notes |
Trial registration: not reported Funding sources: none reported Disclosures of interest: none Study period: not reported Reported subgroup analyses: no |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization sequence not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Masking of participants and personnel (performance bias) | Low risk | "The medication selected was masked to both the patient and the physician." |
Masking of outcome assessment (detection bias) | Unclear risk | No information on efforts to mask the outcome assessors reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear whether there were any missing data or how they were handled. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting. |
Other bias | Low risk | None |