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. 2023 Mar 20;2023(3):CD008721. doi: 10.1002/14651858.CD008721.pub3

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
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.
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.
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
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.