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. 2018 Apr 18;2018(4):CD011599. doi: 10.1002/14651858.CD011599.pub2

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.
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
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.
Outcomes Primary outcome:
  • Change in BCVA at 1 year (LogMAR chart)


Secondary outcome
  • Change in CMT at 1 year (Stratus OCT 3; Carl Zeiss Meditec)


Length of follow‐up: 1 year
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)
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.