Carassa 1992.
Methods |
Study design: parallel‐group RCT Country: Italy Number randomized: Total: 30 total, 10 who underwent trabeculoplasty Per group: within the trabeculoplasty group, apraclonidine = 5, placebo = 5 Exclusions after randomization: none Number analyzed: Total: 30 total, 10 who underwent trabeculoplasty Per group: within the trabeculoplasty group, apraclonidine = 5, placebo = 5 Unit of analysis (participants vs eyes): participant (1 eye per participant) Losses to follow‐up: none How was missing data handled?: N/A Reported power calculation: no Unusual study design (any issues with study design)?: baseline demographics and other characteristics not reported |
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Participants |
Age: not reported Females: not reported Inclusion criteria: aged ≥ 18 years, scheduled for LTP, iridotomy, or posterior capsulotomy Exclusion criteria: active ocular infection or inflammation, past or present severe ocular disease (except cataract and glaucoma, unstable cardiovascular disease, any abnormality preventing reliable applanation tonometry, pregnancy (actual or potential) or breastfeeding, 1 single seeing eye, treatment systemic clonidine, previous enrollment of the fellow eye in the study Equivalence of baseline characteristics: baseline characteristics not reported |
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Interventions |
Intervention 1: 1 drop apraclonidine 1%, 1 hour prior and 1 drop immediately after 360° ALT surgery Intervention 2: 1 drop placebo, 1 hour prior and 1 drop immediately after 360° ALT surgery Length of follow‐up: Planned: 1 week Actual: only up to 3 hours was reported |
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Outcomes |
Primary outcomes: mean IOP and IOP changes during the postoperative period, maximum IOP increases from baseline, IOP increase of 5 mmHg and 10 mmHg from baseline Secondary outcomes: heart rate, BP Adverse events reported: yes Intervals at which outcomes assessed: baseline; 1, 2, 3 hours |
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Notes |
Trial registration: not reported Funding sources: none reported Disclosures of interest: not reported Study period: not reported Reported subgroup analyses: yes, subgroups were different laser procedures |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The study was designed as a prospective, randomized, double‐masked, and placebo‐controlled trial." States randomization was done but not the method of randomization. |
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) | High risk | Masking of outcome assessors not reported; however, apraclonidine can cause conjunctival blanching and eyelid raising, which would have been visible to the person assessing IOP after the procedure. |
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) | High risk | In the methods, the authors stated that, "Ocular examination, heart rate count and blood pressure measurement were repeated hourly during the first three postoperative hours and again one week post operatively;" however, no data were presented from the 1‐week assessments. |
Other bias | High risk | Funding sources not reported, very small sample sizes within the different surgeries do not allow for statistical analyses for each surgery alone; authors stated, "Due to the low numbers of cases in each series, individual statistical analyses for each of the 3 series were considered inappropriate." |