Cheema 2009.
| Methods | Study design: prospective, randomised, clinical trial of intravitreal bevacizumab in cataract surgery for preventing progression of diabetic retinopathy Unit of randomisation: participant Unit of analyses: the eye, but 1 eye of each participant was included in the study Follow‐up: 1 day; 1, 2 and 4 weeks and then at monthly intervals for 6 months |
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| Participants | Country: Saudi Arabia Setting: hospital, Dhahran, Kingdom of Saudi Arabia Number of participants: 68 (68 eyes) Exclusions post‐randomisation: 0 Losses to follow‐up: 0 Age (mean): 66.14 years in bevacizumab group, 64.5 years in control group Gender: 43 men and 25 women Inclusion criteria: cataract in people with diabetes with poor fundus view with 1. the presence of clinically significant macular oedema, 2. mild, moderate, severe or very severe non‐PDR or PDR or 3. a combination of 1 and 2; people with previous focal or grid laser photocoagulation for macular oedema Exclusion criteria: eyes with glaucoma, uveitis and age‐related macular degeneration or a history of trauma or ocular surgery; people with previous panretinal laser photocoagulation |
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| Interventions | Treatment: phacoemulsification with intraocular lens implantation and intravitreal bevacizumab 1.25 mg at the end of surgery Control: phacoemulsification with intraocular lens implantation alone Duration: only 1 dose |
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| Outcomes | Primary: progression of postoperative diabetic retinopathy and diabetic maculopathy during a 6‐month follow‐up Secondary: change in BCVA, changes in central macular thickness and macular thickness determined by optical coherence tomography, postoperative laser therapy, progression to neovascular glaucoma |
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| Notes | Funding: not reported Trial registration: not reported Date conducted: the participants were recruited between February and December 2007 Conflict of interest: none reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomized to a standardized procedure of phacoemulsification with IOL [intraocular lens] implantation alone (control group) or to receive 1.25 mg intravitreal bevacizumab (Avastin) at the end of surgery (intervention group)" Comment: not described how it was generated the random |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Progression of DR [diabetic retinopathy] was based on assessment in a masked fashion by 2 retina specialists (R.A.C., Y.M.A.)" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were 0 losses |
| Selective reporting (reporting bias) | Low risk | Comment: the results of the variables were described in the methods section |