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Foss, Alexander J; Gregson, Richard M; MacKeith, Daisy; Herbison, Nicola; Ash, Isabel M; Cobb, Sue V; Eastgate, Richard M; Hepburn, Trish; Vivian, Anthony; Moore, Diane; Haworth, Stephen M (2013)
Publisher: BioMed Central
Journal: Trials
Languages: English
Types: Article
Subjects: Medicine (miscellaneous), Amblyopia, Lazy eye, Visual acuity, Study Protocol, I-BiT™, Randomised clinical trial, Binocular, Pharmacology (medical), Child

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mesheuropmc: genetic structures, eye diseases
Background: Amblyopia (lazy eye) affects the vision of approximately 2% of all children. Traditional treatment\ud consists of wearing a patch over their ‘good’ eye for a number of hours daily, over several months. This treatment is\ud unpopular and compliance is often low. Therefore results can be poor. A novel binocular treatment which uses 3D\ud technology to present specially developed computer games and video footage (I-BiT™) has been studied in a small\ud group of patients and has shown positive results over a short period of time. The system is therefore now being\ud examined in a randomised clinical trial.\ud Methods/design: Seventy-five patients aged between 4 and 8 years with a diagnosis of amblyopia will be\ud randomised to one of three treatments with a ratio of 1:1:1 - I-BiT™ game, non-I-BiT™ game, and I-BiT™ DVD. They\ud will be treated for 30 minutes once weekly for 6 weeks. Their visual acuity will be assessed independently at baseline,\ud mid-treatment (week 3), at the end of treatment (week 6) and 4 weeks after completing treatment (week 10).\ud The primary endpoint will be the change in visual acuity from baseline to the end of treatment. Secondary\ud endpoints will be additional visual acuity measures, patient acceptability, compliance and the incidence of adverse\ud events.\ud Discussion: This is the first randomised controlled trial using the I-BiT™ system. The results will determine if the\ud I-BiT™ system is effective in the treatment of amblyopia and will also determine the optimal treatment for future\ud development.\ud Trial registration: ClinicalTrials.gov identifier: NCT01702727\ud Keywords: Amblyopia, I-BiT™, Randomised clinical trial, Lazy eye, Child, Visual acuity, Binocular

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