Chevrier 1999.
Methods |
Study design: parallel‐group RCT Country: Canada Number randomized: Total: all laser treatments = 85, trabeculoplasty = 51 Per group: all laser treatments, brimonidine = 43, apraclonidine = 42; trabeculoplasty, brimonidine = 27, apraclonidine = 24 Exclusions after randomization: none reported Number analyzed: Total: all laser treatments = 85; trabeculoplasty = 51 Per group: all laser treatments, brimonidine = 43, apraclonidine = 42; trabeculoplasty, brimonidine = 27, apraclonidine = 24 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)?: none |
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Participants |
Age (mean ± SD; years): (only available for all laser treatments): brimonidine = 70 ± 12.0, apraclonidine = 67.3 ± 13.7 Females: (only available for all laser treatments): brimonidine = 67%, apraclonidine = 45% Inclusion criteria: medically uncontrolled IOP, any type of glaucoma, initial or repeat ALTs 180° to any quadrant Exclusion criteria: chronic topical alpha‐2 agonist therapy, use of topical alpha‐2 agonist within the past 2 weeks, active ocular infection or inflammation, abnormality precluding reliable applanation tonometry, unable to stay for the 1‐hour follow‐up IOP check Equivalence of baseline characteristics: no, "No significant difference were found among treatment groups in terms of age, race, or baseline IOP…There was a statistically significant difference in the gender distribution between groups…" Also noted that uneven distribution of pseudoexfoliation pigmentary glaucoma/mixed glaucoma may affect post laser IOP spike numbers |
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Interventions |
Intervention 1: 1 drop apraclonidine hydrochloride 0.5%, 10 min prior to laser surgery Intervention 2: 1 drop brimonidine tartrate 0.2%, 10 min prior to laser surgery Length of follow‐up: Planned: 1 hour Actual: 1 hour |
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Outcomes |
Primary outcome: IOP Secondary outcomes: mean IOP change, IOP elevation ≥ 5 mmHg change from baseline Adverse events reported: yes, reported no systemic or localized ocular reactions and no other adverse effects Intervals at which outcomes assessed: baseline; 1 hour after surgery |
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Notes |
Trial registration: not reported Funding sources: not reported Disclosures of interest: "The authors hold no proprietary interest in the drugs used in this study." Study period: January 1998 to May 1998 Reported subgroup analyses: yes, subgroups were different types of anterior segment laser procedures |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization method not reported. |
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) | Low risk | IOP analysis performed by the same masked observer at 1 hour post laser, every effort was made to use the same tonometer as prior to surgery. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up; all participants who were randomized completed all assessments. Exclusion criteria was for people who could stay for 1 hour post laser surgery, so there was no attrition. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting. |
Other bias | Unclear risk | Funding sources not reported. Also, this study reported subgroup analysis for the ALT group but did not report baseline demographics by subgroup. |