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Randomized Controlled Trial
. 2013 May 20:14:145.
doi: 10.1186/1745-6215-14-145.

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

Alexander J Foss  1 , Richard M Gregson, Daisy MacKeith, Nicola Herbison, Isabel M Ash, Sue V Cobb, Richard M Eastgate, Trish Hepburn, Anthony Vivian, Diane Moore, Stephen M Haworth; I-BiT Steering group
Affiliations
Randomized Controlled Trial

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

Alexander J Foss et al. Trials. .

Abstract

Background: Amblyopia (lazy eye) affects the vision of approximately 2% of all children. Traditional treatment consists of wearing a patch over their 'good' eye for a number of hours daily, over several months. This treatment is unpopular and compliance is often low. Therefore results can be poor. A novel binocular treatment which uses 3D technology to present specially developed computer games and video footage (I-BiT™) has been studied in a small group of patients and has shown positive results over a short period of time. The system is therefore now being examined in a randomised clinical trial.

Methods/design: Seventy-five patients aged between 4 and 8 years with a diagnosis of amblyopia will be 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 will be treated for 30 minutes once weekly for 6 weeks. Their visual acuity will be assessed independently at baseline, mid-treatment (week 3), at the end of treatment (week 6) and 4 weeks after completing treatment (week 10). The primary endpoint will be the change in visual acuity from baseline to the end of treatment. Secondary endpoints will be additional visual acuity measures, patient acceptability, compliance and the incidence of adverse events.

Discussion: This is the first randomised controlled trial using the I-BiT™ system. The results will determine if the I-BiT™ system is effective in the treatment of amblyopia and will also determine the optimal treatment for future development.

Trial registration: ClinicalTrials.gov identifier: NCT01702727.

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Figures

Figure 1
Figure 1
Outline of study procedures.
Figure 2
Figure 2
Classification of adverse effects.
See this image and copyright information in PMC

References

    1. Von Noorden GK, Campos EC. Binocular Vision and Ocular Motility: Theory and Management of Strabismus. St Louis, MO: Mosby; 2002. Principles of non-surgical treatment; pp. 546–547.
    1. Stewart CE, Fielder AR, Stephens DA, Moseley MJ. Treatment of unilateral amblyopia: factors influencing visual outcome. Invest Ophthalmol Vis Sci. 2005;46:3152–3160. doi: 10.1167/iovs.05-0357. - DOI - PubMed
    1. Stewart CE, Moseley MJ, Stephens DA, Fielder AR. in behalf of the MOTAS Cooperative. Treatment dose–response in amblyopia therapy: The Monitored Occlusion Treatment Of Amblyopia Study (MOTAS) Invest Ophthalmol Vis Sci. 2004;45:3048–3054. doi: 10.1167/iovs.04-0250. - DOI - PubMed
    1. Dixon-Woods M, Awan M, Gottlob I. Why is compliance with occlusion therapy for amblyopia so hard? A qualitative study. Arch Dis Child. 2006;91:491–494. doi: 10.1136/adc.2005.090373. - DOI - PMC - PubMed
    1. Waddingham PE, Butler TKH, Cobb SV, Moody AD, Comaish IF, Haworth SM, Gregson RM, Ash IM, Brown SM, Eastgate RM, Griffiths GD. Preliminary results from the use of the novel Interactive Binocular Treatment (I-BiT) System in the treatment of amblyopia. Eye. 2006;20:375–378. doi: 10.1038/sj.eye.6701883. - DOI - PubMed

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