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. and Gregson, Richard M. and MacKeith, Daisy and Herbison, Nicola and Ash, Isabel M. and Cobb, Sue V. and Eastgate, Richard M. and Hepburn, Trish and Vivian, Anthony and Moore, Diane and Haworth, Stephen 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). 145/1-145/7. ISSN 1745-6215

[img] PDF - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
Available under Licence Creative Commons Attribution.
Download (311kB)

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

Item Type: Article
Schools/Departments: University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine
Depositing User: de Sousa, Mrs Shona
Date Deposited: 11 Apr 2014 13:03
Last Modified: 17 Sep 2016 11:51
URI: http://eprints.nottingham.ac.uk/id/eprint/2928

Actions (Archive Staff Only)

Edit View Edit View