Robin 1987.
Methods |
Study design: parallel‐group RCT Country: US Number randomized: Total: 73 Per group: apraclonidine = 39, placebo = 34 Exclusions after randomization: none reported Number analyzed: Total: 73 Per group: apraclonidine = 39, placebo = 34 Unit of analysis (participants vs eyes): participant (1 eye per participant); if a participant required bilateral therapy, the eye treated first was selected Losses to follow‐up: none reported How was missing data handled?: not reported Reported power calculation: no Unusual study design?: none |
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Participants |
Age (mean ± SD; years): apraclonidine = 60.9 ± 14.3, placebo = 68.8 ± 12.4 Females: apraclonidine = 54%, placebo = 74% Inclusion criteria: pre‐existing OAG and poor IOP control despite maximum tolerated medical therapy Exclusion criteria: prior ALT Equivalence of baseline characteristics: no, "There was no statistically significant difference in any variable except for mean patient age, (P<0.25)" |
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Interventions |
Intervention 1: topical 1% apraclonidine, 1 hour prior and immediately after 360° ALT Intervention 2: placebo, 1 hour prior and immediately after 360° ALT Length of follow‐up: Planned: 1 month Actual: 1 month |
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Outcomes |
Primary outcomes: visual acuity, IOP, anterior segment inflammation Secondary outcome: heart rate Adverse events reported: authors reported that there were no adverse events Intervals at which outcomes assessed: 1, 2, 3 hours; 1 week; 1 month |
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Notes |
Trial registration: not reported Funding sources: "This study was funded in part by a grant from Alcon Laboratories." Disclosures of interest: "Betty House is an employee of Alcon Laboratories, Fort Worth, Tex. None of the authors as any financial, commercial, or proprietary interest in ALO 2145 [apraclonidine]." 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) | Low risk | "A computer‐generated random‐number table was utilized, and the selected medication was masked to both the physician and the patient." |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Masking of participants and personnel (performance bias) | Low risk | "A computer‐generated random‐number table was utilized, and the selected medication was masked to both the physician and the patient." |
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 | No mention of loss to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting. |
Other bias | High risk | Study funded in part by Alcon Laboratories, who manufacture the study drug apraclonidine. |