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

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
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
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
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
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
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."