title: Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 One participant was randomised twice and withdrawn from the study.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 Three participants were withdrawn at week 6, and in total, four were lost to follow-up at week 12.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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, 162 City Road, London, EC1V 2PD UK.
authors.forename: Vijay K
authors.initials: VK
authors.lastname: Tailor
authors.affiliation: 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.
authors.forename: Selina
authors.initials: S
authors.lastname: Glaze
authors.affiliation: 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.
authors.forename: Payal
authors.initials: P
authors.lastname: Khandelwal
authors.affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, 162 City Road, London, EC1V 2PD UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Davis
authors.affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, 162 City Road, London, EC1V 2PD UK.
authors.forename: Gillian G W
authors.initials: GG
authors.lastname: Adams
authors.affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, 162 City Road, London, EC1V 2PD UK.
authors.forename: Wen
authors.initials: W
authors.lastname: Xing
authors.affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, 162 City Road, London, EC1V 2PD UK.
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.affiliation: 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.
authors.forename: Annegret
authors.initials: A
authors.lastname: Dahlmann-Noor
keywords: Amblyopia; Child; Clinical trial