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. 2017 Feb 23;2017(2):CD010746. doi: 10.1002/14651858.CD010746.pub2

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)."
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."
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
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
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
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.