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

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.

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
Keywords: Amblyopia, I-BiT™, Randomised clinical trial, Lazy eye, Child, Visual acuity, Binocular

Citation

Foss, A. J., Gregson, R. M., MacKeith, D., Herbison, N., Ash, I. M., Cobb, S. V., Eastgate, R. M., Hepburn, T., Vivian, A., Moore, D., & Haworth, S. M. (2013). 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. Trials, 14(145), Article 145. https://doi.org/10.1186/1745-6215-14-145

• Journal Article Type: Article
• Publication Date: May 20, 2013
• Deposit Date: Apr 11, 2014
• Publicly Available Date: Apr 11, 2014
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 14
• Issue: 145
• Article Number: 145
• DOI: https://doi.org/10.1186/1745-6215-14-145
• Public URL: https://nottingham-repository.worktribe.com/output/715051
• Publisher URL: http://www.trialsjournal.com/content/14/1/145