Yalvaç 1996.
Methods |
Study design: parallel‐group RCT Country: Turkey Number randomized: Total: 48 Per group: apraclonidine/180° ALT = 16, apraclonidine/360° ALT = 16, placebo/180° ALT = 16 Exclusions after randomization: none reported Number analyzed: Total: 48 Per group: apraclonidine/180° ALT = 16, apraclonidine/360° ALT = 16, placebo/180° ALT = 16 Unit of analysis (participants vs eyes): participant (1 eye per person) Losses to follow‐up: none reported How was missing data handled?: N/A Reported power calculation: no Unusual study design?: none |
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Participants |
Age (mean ± SD; years): apraclonidine/180° ALT = 63.3 ± 8.8, apraclonidine/360° ALT = 65.5 ± 7.4, placebo/180° ALT = 62.1 ± 8.3 Females: apraclonidine/180° ALT = 25%, apraclonidine/360° ALT = 38%, placebo/180° ALT = 31% Inclusion criteria: people with POAG, defined by optic disk cupping and visual field loss and a pretreatment IOP > 21 mmHg on maximally tolerated medical therapy Exclusion criteria: previous intraocular surgical procedures or laser treatment, secondary OAG (i.e. pigmentary, exfoliative, or uveitic), and aged < 40 years Equivalence of baseline characteristics: yes, "There were no significant differences among the three groups in terms of average age, gender, preoperative IOP, or number of antiglaucoma medications (P>0.05)." |
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Interventions |
Intervention 1: apraclonidine 1%, 1 hour before and immediately after 180° ALT Intervention 2: apraclonidine 1%, 1 hour before and immediately after 360° ALT Intervention 3: placebo, 1 hour before and immediately after 180° ALT Length of follow‐up: Planned: 3 hours Actual: 3 hours |
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Outcomes |
Primary outcomes: IOP change, frequency of IOP elevation Secondary outcomes: none reported Adverse events reported: no Intervals at which outcomes assessed: baseline; 1, 2, 3 hours after treatment |
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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: no |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization sequence generation 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) | Low risk | "IOP was measured preoperatively and 1, 2, and 3 hours after treatment by an observer who was blinded to the random assignment of treatment with the drugs." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study did not address whether outcome data were complete at each time point, but study only lasted 3 hours post‐ALT. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting. |
Other bias | Unclear risk | Funding sources not reported. |
ALT: argon laser trabeculoplasty; BP: blood pressure; IOP: intraocular pressure; LTP: laser trabeculoplasty; min: minute; N/A: not applicable; Nd:YAG: neodymium‐doped yttrium aluminum garnet; OAG: open‐angle glaucoma; POAG: primary open‐angle glaucoma; RCT: randomized controlled trial; SD: standard deviation; SLT: selective laser trabeculoplasty.