title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01702727.
authors.affiliation: Human Factors Research Group, University of Nottingham, University Park, Nottingham NG7 2RD, UK. alexander.foss@nottingham.ac.uk
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Foss
authors.forename: Richard M
authors.initials: RM
authors.lastname: Gregson
authors.forename: Daisy
authors.initials: D
authors.lastname: MacKeith
authors.forename: Nicola
authors.initials: N
authors.lastname: Herbison
authors.forename: Isabel M
authors.initials: IM
authors.lastname: Ash
authors.forename: Sue V
authors.initials: SV
authors.lastname: Cobb
authors.forename: Richard M
authors.initials: RM
authors.lastname: Eastgate
authors.forename: Trish
authors.initials: T
authors.lastname: Hepburn
authors.forename: Anthony
authors.initials: A
authors.lastname: Vivian
authors.forename: Diane
authors.initials: D
authors.lastname: Moore
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Haworth
mesh_terms: D000550:Amblyopia / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003196:Computer Graphics; D004739:England; D005123:Eye / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D017060:Patient Satisfaction; D010775:Photic Stimulation; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D018910:Video Games / Q000009:adverse effects; D014742:Videodisc Recording; D015348:Vision, Binocular; D014792:Visual Acuity; D014796:Visual Perception