Holmwood 1992.
Methods |
Study design: parallel‐group RCT Country: US Number randomized: Total: 60 Per group: apraclonidine before and after = 30, apraclonidine only after = 30 Exclusions after randomization: not reported Number analyzed: Total: 60 Per group: apraclonidine before and after = 30, apraclonidine only after = 30 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 |
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Participants |
Age: not reported Females: not reported Inclusion criteria: people who had 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, people who had secondary OAG (e.g. pigmentary, exfoliative, or uveitic), and aged < 40 years Equivalence of baseline characteristics: yes, "There were no statistical differences between preoperative IOP and the number of antiglaucoma medications between the two groups of patients." |
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Interventions |
Intervention 1: 1 drop apraclonidine 1%, 1 hour before and immediately after 360° LTP Intervention 2: 1 drop apraclonidine 1%, only after 360° LTP Length of follow‐up: Planned: 2 hours Actual: 2 hours |
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Outcomes |
Primary outcome: IOP Secondary outcomes: not reported Adverse events reported: no Intervals at which outcomes assessed: baseline; 1, 2 hours after treatment |
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Notes |
Trial registration: not reported Funding sources: "This study was supported in part by an unrestricted grant from Research to Prevent Blindness, Inc., New York, New York." Disclosures of interest: none 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) | Low risk | "One of the following two apraclonidine open‐label treatment regimens was determined from a random table chart…" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Masking of participants and personnel (performance bias) | High risk | Study was open‐label and no mention of vehicle drops, so participants would be aware whether they received drops before and after surgery or only after surgery. |
Masking of outcome assessment (detection bias) | Low risk | "Intraocular pressure was measured one and two hours after treatment by an observer who was masked to the random assignment to treatment with apraclonidine." |
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 outcome reporting. |
Other bias | Low risk | None |