Sohn 2012.
| Methods | Study design: randomised double‐blind clinical trial Unit of randomisation: eye Unit of analyses: eye Follow‐up: 3 months |
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| Participants | Country: USA Setting: Department of Ophthalmology Number of participants: 19 (20 eyes) Exclusions post‐randomisation: 0 Losses to follow‐up: 2 Age (mean (range)): 52 (31‐64) years Gender: 12 men and 7 women Inclusion criteria: people with TRD or combined TRD/rhegmatogenous retinal detachment secondary to PDR who were given anaesthesia clearance for pars plana vitrectomy. Indications for pars plana vitrectomy included TRD involving the macula, TRD/rhegmatogenous retinal detachment and non‐clearing or recurrent VH precluding complete PRP with TRD not necessarily involving the macula Exclusion criteria: history of pars plana vitrectomy; dense VH preventing preoperative grading of fibrovascular membranes; an inability to return for pars plana vitrectomy within 3‐7 days after randomisation; a history of cerebrovascular accident, thromboembolic event or myocardial infarction within 6 months; aged < 18 years and pregnancy |
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| Interventions | Treatment: intravitreal bevacizumab injection 1.25 mg/0.05 mL, 3‐6 days before surgery Control: sham injection (1 syringe without a needle placed to simulate intravitreal injection) Duration: only 1 dose |
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| Outcomes | Primary: visual acuity at 3 months of follow‐up, vitreous levels of VEGF Secondary: amount of intraoperative bleeding |
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| Notes | Funding: supported by: the Eugene de Juan Jr Award for Innovation (Dr Sohn); the Heed Foundation (Drs Kim and Javaheri); grant K12‐EY16335 from the National Eye Institute, National Institutes of Health (Dr Kim); The Arnold and Mabel Beckman Foundation (Dr Hinton); Research to Prevent Blindness (Department of Ophthalmology, University of Iowa Hospitals and Clinics); and core grant EY03040 from the National Eye Institute (Doheny Eye Institute) Trial registration: not reported Date conducted: not reported Conflict of interest: Dr Hinton served as a consultant to FibroGen, Inc. Dr Eliott served as an ad hoc consultant to Genentech Other comments: participants of the control group had more severe symptoms than the bevacizumab group at baseline: 2 had visually significant cataract (1 participant in each group), 2 had worsening ischaemia (in control group), 1 had severe neovascular glaucoma (in control group) and 1 had VH (in control group) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the patient and surgeon were masked to the patients' randomization group" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the patient and surgeon were masked to the patients' randomization group" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: only 2 participants (1 in each group) were lost during the follow‐up |
| Selective reporting (reporting bias) | Low risk | Comment: the results of the variables were described in the methods section |