Di Lauro 2010.
| Methods | Study design: prospective, randomised, clinical trial of intravitreal bevacizumab for surgical treatment of severe PDR Unit of randomisation: participant Unit of analyses: eye/participant Follow‐up: 1, 6, 12 and 24 weeks after the surgery |
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| Participants | Country: Italy Setting: Department of Ophthalmology, Hospital C.T.O. of Naples, Naples, Italy Number of participants: 68 (72 eyes) Exclusions post‐randomisation: 3 (regression of the haemorrhage in a bevacizumab group) Losses to follow‐up: 0 Age: not reported Gender: not reported Inclusion criteria: people affected by VH and TRD consequent to active PDR Exclusion criteria: people with neovascular glaucoma or cataract (or both) and cases of combined traction and rhegmatogenous retinal diabetes (diagnosed either before or during the surgery) |
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| Interventions | Treatment group 1: intravitreal bevacizumab 1.25 mg/0.05 mL, 7 days before vitrectomy Treatment group 2: intravitreal bevacizumab 1.25 mg/0.05 mL, 20 days before vitrectomy Control: sham injection 20 days before vitrectomy Duration: only 1 dose |
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| Outcomes | Primary: clearing of VH, incidence of adverse effects and the need of other procedures during the surgery Secondary: change in BCVA and duration of surgery |
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| Notes | Funding: not reported Trial registration: NCT01025934 Date conducted: October 2005 to May 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 | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients in group A [control] were given a subconjunctival injection of 0.05 ml of BSS (Blood saline serum) 3 weeks before the vitrectomy" Comment: control received a sham intervention. The participant was blind to the treatment received. However, it is possible that the personnel that administered the sham were aware of treatment because the site of application was subconjunctival and not intravitreal as with bevacizumab |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patients in group A [control] were given a subconjunctival injection of 0.05 ml of BSS (Blood saline serum) 3 weeks before the vitrectomy" Comment: control received a sham intervention. The outcome assessor was blinded to the treatment administered |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were 3 losses post‐randomisation, but losses during follow‐up were not noted |
| Selective reporting (reporting bias) | Low risk | Comment: the results of the variables were reported in the methods section |