Sameen 2017.
Study characteristics | ||
Methods | Study design: randomised clinical trial Unit of randomisation: eyes Unit of analyses:eyes (76 eyes and 50 participants) Follow‐up: 3 months |
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Participants | Country: Pakistan Setting: Armed Forces Institute of Ophthalmology, Rawalpindi. Number of participants: 50 participants (76 eyes) having proliferative diabetic retinopathy (PDR) and diabetic macular oedema (DME) Exclusions post‐randomisation: not described Losses to follow‐up: not described Age (mean (SD)): 57.47 (6.08) in PRP; 55.69 (6.58) in PRP + IVB Gender: Females 24% (PRP); 36% (PRP + IVB) Inclusion criteria: people having PDR with DME and no history of previous treatment. Exclusion criteria: people with poor diabetic control (HbA1C > 7.0%), hypertension (> 140/90), significant lenticular changes, traction, advanced diabetic retinopathy, cystoid macular oedema (CMO) and subretinal serous elevation were also excluded from the study. |
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Interventions | Treatment: PRP + intravitreal bevacizumab 2.5 mg/0.1ml (IVB) Control: PRP alone Duration: IVB injection one day after PRP session and repeated monthly for 3 months. |
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Outcomes | Primary: BCVA and Optical coherence tomography (OCT) | |
Notes | Funding: none. Trial registration: not described Date conducted: from January 2016 to August 2016 Conflict of interest: none |
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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 | High risk | Quote: “All sessions of laser and IVB injections were performed by the second author.” |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: not described |
Selective reporting (reporting bias) | Low risk | Comment: the results of the outcomes were described in the methods section. |