Evaluation and development of a novel binocular treatmentud(I-BiT™) system using video clips and interactive games to ud improve vision in children with amblyopia (‘lazy eye’):ud study protocol for a randomised controlled trial

摘要

Background: Amblyopia (lazy eye) affects the vision of approximately 2% of all children. Traditional treatmentudconsists of wearing a patch over their ‘good’ eye for a number of hours daily, over several months. This treatment isudunpopular and compliance is often low. Therefore results can be poor. A novel binocular treatment which uses 3Dudtechnology to present specially developed computer games and video footage (I-BiT™) has been studied in a smalludgroup of patients and has shown positive results over a short period of time. The system is therefore now beingudexamined in a randomised clinical trial.udMethods/design: Seventy-five patients aged between 4 and 8 years with a diagnosis of amblyopia will beudrandomised to one of three treatments with a ratio of 1:1:1 - I-BiT™ game, non-I-BiT™ game, and I-BiT™ DVD. Theyudwill be treated for 30 minutes once weekly for 6 weeks. Their visual acuity will be assessed independently at baseline,udmid-treatment (week 3), at the end of treatment (week 6) and 4 weeks after completing treatment (week 10).udThe primary endpoint will be the change in visual acuity from baseline to the end of treatment. Secondaryudendpoints will be additional visual acuity measures, patient acceptability, compliance and the incidence of adverseudevents.udDiscussion: This is the first randomised controlled trial using the I-BiT™ system. The results will determine if theudI-BiT™ system is effective in the treatment of amblyopia and will also determine the optimal treatment for futureuddevelopment.udTrial registration: ClinicalTrials.gov identifier: NCT01702727udKeywords: Amblyopia, I-BiT™, Randomised clinical trial, Lazy eye, Child, Visual acuity, Binocular