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

被引:22
作者
Foss, Alexander J. [1 ,2 ]
Gregson, Richard M. [2 ]
MacKeith, Daisy [2 ]
Herbison, Nicola [2 ]
Ash, Isabel M. [2 ]
Cobb, Sue V. [1 ]
Eastgate, Richard M. [1 ]
Hepburn, Trish [1 ]
Vivian, Anthony [3 ]
Moore, Diane [3 ]
Haworth, Stephen M. [2 ]
机构
[1] Univ Nottingham, Human Factors Res Grp, Nottingham NG7 2RD, England
[2] Nottingham Univ Hosp NHS Trust, Nottingham NG7 2RB, England
[3] Addenbrookes Hosp, Cambridge CB2 0QQ, England
基金
英国惠康基金;
关键词
Amblyopia; I-BiT (TM); Randomised clinical trial; Lazy eye; Child; Visual acuity; Binocular; THERAPY;
D O I
10.1186/1745-6215-14-145
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
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 (TM)) 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 (TM) game, non-I-BiT (TM) game, and I-BiT (TM) 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 (TM) system. The results will determine if the I-BiT (TM) system is effective in the treatment of amblyopia and will also determine the optimal treatment for future development. Trial registration: ClinicalTrials.gov identifier: NCT01702727
引用
收藏
页数:7
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