Ma 1999.
Methods |
Study design: parallel‐group RCT Country: Korea Number randomized: Total: 80 Per group: brimonidine/brimonidine = 20; brimonidine/placebo = 20, placebo/brimonidine = 20, placebo/placebo = 20 Exclusions after randomization: none reported Number analyzed: Total: 80 Per group: brimonidine/brimonidine = 20; brimonidine/placebo = 20, placebo/brimonidine = 20, placebo/placebo = 20 Unit of analysis (participants vs eyes): participant (1 eye per participant) Losses to follow‐up: none reported How was missing data handled?: N/A Reported power calculation: no Unusual study design?: none |
|
Participants |
Age (mean ± SD; years): overall = 58.4 ± 8.9, brimonidine/brimonidine = 57.7, brimonidine/placebo = 58.0, placebo/brimonidine = 60.6, placebo/placebo = 57.5 Females: brimonidine/brimonidine = 35%, brimonidine/placebo = 55%, placebo/brimonidine = 55%, placebo/placebo = 45% Inclusion criteria: none listed Exclusion criteria: people who had glaucoma or intraocular surgery, who had already received any systemic alpha‐agonist or had a hypersensitivity to any alpha‐agonist Equivalence of baseline characteristics: yes, "No significant pretreatment differences in terms of age, sex, iris color, or baseline IOP were noted among treatment groups." |
|
Interventions |
Intervention 1: brimonidine 0.2%, 30 to 60 min before and immediately after 180° ALT Intervention 2: brimonidine 0.2%, 30 to 60 min before and placebo immediately after 180° ALT Intervention 3: placebo, 30 to 60 min before and brimonidine 0.2% immediately after 180° ALT Intervention 4: placebo, 30 to 60 min before and immediately after Length of follow‐up: Planned: 4 weeks Actual: 4 weeks |
|
Outcomes |
Primary outcome: IOP Secondary outcomes: IOP of the contralateral eye, mean heart rate, systolic BP Adverse events reported: yes Intervals at which outcomes assessed: 1, 2, 3 hours; 1 day; 1, 4 weeks |
|
Notes |
Trial registration: not reported Funding sources: "This study was supported by the Research Institute of Clinical Medicine, Chonnam University Hospital." Disclosures of interest: none reported Study period: not reported Reported subgroup analyses: no |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization sequence not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Masking of participants and personnel (performance bias) | Unclear risk | No information on masking of participants and personnel reported. |
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 | Unclear whether there were any missing data or how they were handled. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective reporting. |
Other bias | Low risk | None |