Manabe 2015.
Methods | Prospective, double‐masked randomised controlled trial Country: Japan |
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Participants | Number: 62 people (66 eyes) Age: average 60 years (range 20 to 82) Sex: 82% male Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention:
Comparator:
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Outcomes | Primary outcome:
Secondary outcome measures:
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Notes | Trial registration number: NCT01854593 Date study conducted: June 2012 to August 2013 Funding: not reported Conflict of interest: reported "none" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Low risk | "...were randomised using the envelop method" "Both the investigators and patients were masked to the treatment assignment". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Both the investigators and patients were masked to the treatment assignment". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All postoperative examinations were performed by three vitreoretinal surgeons (H.S., T.H., H.N.) who also were masked to the study group allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were followed up for 1 month |
Selective reporting (reporting bias) | Low risk | All outcomes on trial registry entry reported |