Tailor Vijay K, Glaze Selina, Khandelwal Payal, Davis Alison, Adams Gillian G W, Xing Wen, Bunce Catey, Dahlmann-Noor Annegret
NIHR Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, 162 City Road, London, EC1V 2PD UK.
Moorfields at Bedford Hospital NHS Trust, Kempston Road, Bedford, MK42 9DJ UK ; South Essex Partnership Foundation Trust, Enhanced Services Centre, 3 Kimbolton Road, Bedford, MK40 2NT UK.
Pilot Feasibility Stud. 2015 Jun 11;1:23. doi: 10.1186/s40814-015-0018-y. eCollection 2015.
Amblyopia ("lazy eye") is the commonest vision deficit in children. If not fully corrected by glasses, amblyopia is treated by patching or blurring the better-seeing eye. Compliance with patching is often poor. Computer-based activities are increasingly topical, both as an adjunct to standard treatment and as a platform for novel treatments. Acceptability by families has not been explored, and feasibility of a randomised controlled trial (RCT) using computer games in terms of recruitment and treatment acceptability is uncertain.
We carried out a pilot RCT to test whether computer-based activities are acceptable and accessible to families and to test trial methods such as recruitment and retention rates, randomisation, trial-specific data collection tools and analysis. The trial had three arms: standard near activity advice, Eye Five, a package developed for children with amblyopia, and an off-the-shelf handheld games console with pre-installed games. We enrolled 60 children age 3-8 years with moderate or severe amblyopia after completion of optical treatment.
This trial was registered as UKCRN-ID 11074. Pre-screening of 3600 medical notes identified 189 potentially eligible children, of whom 60 remained eligible after optical treatment, and were enrolled between April 2012 and March 2013. One participant was randomised twice and withdrawn from the study. Of the 58 remaining, 37 were boys. The mean (SD) age was 4.6 (1.7) years. Thirty-seven had moderate and 21 severe amblyopia. Three participants were withdrawn at week 6, and in total, four were lost to follow-up at week 12. Most children and parents/carers found the study procedures, i.e. occlusion treatment, usage of the allocated near activity and completion of a study diary, easy. The prescribed cumulative dose of near activity was 84 h at 12 weeks. Reported near activity usage numbers were close to prescribed numbers in moderate amblyopes (94 % of prescribed) but markedly less in severe amblyopes (64 %). Reported occlusion usage at 12 weeks was 90 % of prescribed dose for moderate and 33 % for severe amblyopes.
Computer-based games and activities appear acceptable to families as part of their child's amblyopia treatment. Trial methods were appropriate and accepted by families.
弱视（“懒眼症”）是儿童中最常见的视力缺陷。如果弱视不能通过眼镜完全矫正，则通过遮盖或模糊视力较好的眼睛来治疗。遮盖治疗的依从性通常较差。基于计算机的活动作为标准治疗的辅助手段以及新治疗方法的平台，越来越受到关注。尚未探讨家庭对其的接受程度，并且使用电脑游戏进行随机对照试验（RCT）在招募和治疗可接受性方面的可行性尚不确定。
我们进行了一项试点随机对照试验，以测试基于计算机的活动对家庭是否可接受且易于实施，并测试诸如招募和保留率、随机化、特定试验数据收集工具及分析等试验方法。该试验有三个组：标准近距活动建议组、Eye Five组（为弱视儿童开发的一套方案）以及配备预装游戏的现成掌上游戏机组。我们纳入了60名年龄在3至8岁之间、完成光学治疗后患有中度或重度弱视的儿童。
该试验注册编号为UKCRN-ID 11074。对3600份病历进行预筛查后，确定了189名潜在符合条件的儿童，其中60名在光学治疗后仍符合条件，并于2012年4月至2013年3月期间入组。一名参与者被随机分配了两次并退出研究。在其余58名参与者中，37名是男孩。平均（标准差）年龄为4.6（1.7）岁。37名患有中度弱视，21名患有重度弱视。3名参与者在第6周退出，总共有4名在第12周失访。大多数儿童和家长/照顾者认为研究程序，即遮盖治疗、使用分配的近距活动以及完成研究日记，很容易。规定的近距活动累积剂量在12周时为84小时。报告的近距活动使用次数在中度弱视患者中接近规定次数（为规定次数的94%），但在重度弱视患者中明显较少（为64%）。报告的12周时遮盖使用情况在中度弱视患者中为规定剂量的90%，在重度弱视患者中为33%。
基于计算机的游戏和活动作为儿童弱视治疗的一部分，似乎为家庭所接受。试验方法是合适的，并且为家庭所接受。
