Lim 2012.
Methods |
Study design: parallel group RCT Unit of randomisation: participants were randomly allocated to treatment. For participants with both eyes eligible on entry, the allocated randomised treatment was applied to the right eye, whereas the left eye received the other treatment. Number randomised: Total: 120 eyes, 110 participants, 10 people had both eyes enrolled Unit of analysis: individual eyes Number analysed: Total: 111 eyes There were 6 study eyes lost to follow‐up and 3 eyes declined to continue intervention Intervention arms: 36 eyes anti‐VEGF/steroid, 38 eyes anti‐VEGF, 37 eyes IVS There were 36 eyes per group required for an 80% power to detect a significance level of 5% in a two‐sided test of the outcome measures. |
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Participants |
Country: South Korea Mean age: 60 years Sex: 55 women; 50 men Underlying condition: DMO Inclusion criteria: eyes with clinically significant DMO based on ETDRS criteria. Macular oedema with CMT of at least 300 µm by optical coherence tomography Exclusion criteria: unstable medical status, previous treatment for DMO, history of vitreoretinal surgery, uncontrolled glaucoma; proliferative diabetic retinopathy with active neovascularisation, previous panretinal photocoagulation, presence of vitreomacular traction, history of systemic corticosteroids use in last 6 months |
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Interventions |
Intervention: Intravitreal bevacizumab (1.25mg/0.05ml) and intravitreal triamcinolone acetonide (2mg/0.05ml) Comparator 1: Intravitreal bevacizumab (1.25mg/0.05ml) Comparator 2: intravitreal triamcinolone acetonide (2mg/0.05ml) Bevacizumab was given as 2 injections at 6‐week intervals. During follow‐up, all three groups received repeated bevacizumab injections when CMT was greater than 300 μm on OCT at 6 week intervals. |
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Outcomes |
Primary outcome:
Secondary outcome
Length of follow‐up: 1 year |
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Notes |
Trial registration: NCT01342159 Source of funding: not reported Declaration of interest: Quote "No conflicting relationship exists for any author." Date study conducted: March 2008 to February 2010 (start date was March 2009 on clinical trials.gov) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "Randomization was performed using a random block permutation method according to a computer‐generated randomization list. Block lengths varied randomly" |
Allocation concealment (selection bias) | Low risk | Quote "The random allocation sequence was performed by a biostatistician. Details of the series were unknown to the investigators." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Authors do not state whether investigators or participants were masked to treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote "Visual acuity assessment and OCT were performed by an optometrist who was blinded to the group status of the patients." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Nine study eyes did not complete the study. In the case of 3 eyes, it was because the person refused the intervention, reasons for the other 6 eyes lost to follow‐up was not stated. It was not reported which group these eyes were randomly allocated to. |
Selective reporting (reporting bias) | Low risk | VA and CMT outcomes reported at 6 weeks and at 3, 6 and 12 months. Rates of cataract progression, ocular hypertension, vitreous haemorrhage, retinal detachment, endophthalmitis, increase in blood pressure and thromboembolic events were also recorded. |
Other bias | Unclear risk | Both eyes being eligible to allocation in a single individual poses the theoretical potential to influence outcomes in the fellow eye via systemic absorption. |