Hartenbaum 1999.
Methods |
Study design: parallel‐group, placebo controlled, RCT Country: US (multicenter) Number randomized: Total: 122 Per group: dorozolamide = 61, placebo = 61 Exclusions after randomization: none reported Number analyzed: Total: 122 Per group: dorozolamide = 61, placebo = 61; in ALT group: dorozolamide = 17, placebo = 23 Unit of analysis: participant (1 eye per person) Losses to follow‐up: none reported How was missing data handled?: missing data were imputed by carrying forward data from the previous time point Reported power calculation: yes, "With 60 patients per group, there was 90% power to detect such a difference at the P<0.05‐level (two‐sided)." |
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Participants |
Age: not reported Females: not reported Inclusion criteria: to have posterior capsular opacity requiring Nd:YAG laser capsulotomy, OAG requiring ALT or any condition requiring ALT or Nd:YAG laser iridotomy Exclusion criteria: ocular inflammation within the past 2 months, advanced visual field defects with risk of further loss if a spike in IOP were to occur, baseline IOP > 30 mmHg, use of corticosteroid, oral beta‐blocker, or oral carbonic anhydrase inhibitor therapy Equivalence of baseline characteristics: yes, "Baseline characteristics were similar in both treatment groups." |
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Interventions |
Intervention 1: 1 drop dorozolamide hydrochloride 2%, 1 hour before and 1 drop at the end of surgery Intervention 2: 1 drop placebo, 1 hour before and 1 drop immediately after Length of follow‐up: Planned: 24 hours Actual: 24 hours |
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Outcomes |
Primary outcome: percentage of participants with an increase in IOP from the baseline of ≥ 10 mmHg during the first 4 hours after surgery Secondary outcomes: heart rate, BP, incidence of adverse effects, ocular signs Adverse events reported: yes Intervals at which outcomes assessed: baseline; 1, 2, 3, 4, 24 hours |
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Notes |
Trial registration: not reported Funding sources: none reported Disclosures of interest: the Dorzolamide Laser Study Group was sponsored by pharmaceutical research corporation, and multiple authors work for Merck Research Laboratories, which makes dorozolamide. 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 | No description of how randomization sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Masking of participants and personnel (performance bias) | Unclear risk | Authors reported that the study was double‐masked, but did not say who was masked: participants, surgeons, or outcome assessors. |
Masking of outcome assessment (detection bias) | Unclear risk | Authors reported that the study was double‐masked, but did not say who was masked: participants, surgeons, or outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data imputed by carrying forward data from the previous time point, but the authors did not specify how much attrition occurred. |
Selective reporting (reporting bias) | High risk | Did not provide table of baseline characteristics. Did not discuss attrition of study participants, and did not report data at 24 hours despite mentioning it as part of methods section, no mention of specific ocular adverse events, and did not describe number of participants with systemic adverse effects other than to say there was no difference between groups. |
Other bias | High risk | Merck is the maker of dorozolamide, and several authors were employees of Merck. |