Arcieri 2015.
Study characteristics | ||
Methods |
Study design: parallel‐group RCT Setting: multicenter trial in Brazil Number randomized: 40 participants Unit of analysis: participant (one study eye per individual) Maximum planned (or stated) length of follow‐up: 24 months Number not included in final analysis: 14 participants |
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Participants |
Number of men: 13 in the intervention group and 11 in the comparator group Number of women: 7 in the intervention group and 9 in the comparator group Mean age: 59 years in the intervention group and 62 years in the comparator group Mean IOP at baseline: 40 mmHg in the intervention group and 38 mmHg in the comparator group Inclusion criteria: older than 18 years with uncontrolled NVG, defined as an eye with IOP above 22 mm Hg using maximum tolerated glaucoma medication; PRP at least 2 weeks before enrolment Exclusion criteria: no light perception; NVG secondary to intraocular tumors or uveitis; unwilling or unable to return for follow‐up; pregnancy; learning difficulties, mental illness or dementia; previous cyclodestructive procedure, scleral buckle procedure, or silicone oil surgery |
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Interventions |
Intervention (N = 20): 0.05 mL intravitreal bevacizumab (concentration of 25 mg/mL) with Ahmed glaucoma valve implant Comparator (N = 20): 0.05 mL of sterile saline salt solution (placebo) with Ahmed glaucoma valve implant All participants underwent PRP at least 2 weeks prior to enrolment. |
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Outcomes |
From prospective clinical trial registration Primary: IOP control, measured six months after randomization with Goldman applanation tonometer Secondary: safety of intravitreal bevacizumab up to six months after randomization |
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Notes |
Trial registration: ACTRN12607000577415 Study dates: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Eligible patients with NVG were randomised to the following groups using a computer‐generated randomization table". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information – method of sequence allocation not clearly mentioned to permit judgment of low risk or high risk |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear risk of bias, insufficient information to permit judgment of low risk or high risk |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk of bias as outcome assessor did not know the group to which the participant was assigned: "Ophthalmologists responsible for the patients’ follow‐up were masked to the use of IVB". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear risk of bias as data from 10 participants, 5 (25%) from each arm were unavailable at the 1‐year follow‐up |
Selective reporting (reporting bias) | Low risk | No selective reporting identified; outcomes described in trial registration record were reported in full‐text publication. |
Other bias | Unclear risk | Unclear risk of bias – insufficient information to permit judgment of low risk or high risk of bias; this was an unfunded study. |