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. 2023 Apr 3;2023(4):CD007920. doi: 10.1002/14651858.CD007920.pub4

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
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
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.
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
Notes Trial registration: ACTRN12607000577415
Study dates: not reported
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.