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

Stephen M Haworth²  Diane Moore³  Anthony Vivian³  Trish Hepburn¹  Richard M Eastgate¹  Sue V Cobb¹  Isabel M Ash²  Nicola Herbison²  Daisy MacKeith²  Richard M Gregson²  Alexander J Foss² 

[1] Human Factors Research Group, University of Nottingham, University Park, Nottingham NG7 2RD, UK;Nottingham University Hospital NHS Trust, QMC Campus, Derby Road, Nottingham NG7 2RB, UK;Addenbrookes Hospital, Hills Road, Cambridge CB2 0QQ, UK

关键词: Binocular;    Visual acuity;    Child;    Lazy eye;    Randomised clinical trial;    I-BiT™;    Amblyopia;   

Others  :  1093958
DOI  :  10.1186/1745-6215-14-145

 received in 2012-11-20, accepted in 2013-05-01,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Foss et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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