I-BiT Plus version 1.0
Research type
Research Study
Full title
Interactive Binocular Treatment (I-BiT) for the management anisometropic, strabismic and mixed amblyopia in children aged 3.5-9 years.
IRAS ID
198518
Contact name
Rebecca Brown
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
This study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the games accurately if they are using their lazy eye. The study is funded by the NIHR and will be undertaken as a randomised control trial to compare this against normal computer games and DVD viewing combined with continuing refractive adaptation i.e. wearing glasses if necessary (a process that is known to occur for up to 30 weeks). Patients will receive 6 weeks of treatment (recommended 30 mins minimum of play time on 6 days per week for 6 weeks in the treatment arm) and level of vision will be assessed after 6 weeks. The visual improvement (they will be wearing glasses if necessary and also undergoing refractive adaptation) will be compared with the control group. Patients will return to standard care after the trial period which, at 6 weeks, should not affect the final visual outcome in a negative way. The participants will be recruited from patients currently attending one of the 4 trial sites (Nottingham University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Moorfields Eye Hospital and Royal Stoke University Hospital) and will have a diagnosis of amblyopia, and be aged between 3 years 6 months and 9 years 11 months. Current treatments for amblyopia include wearing an eye patch over the good eye for up to 6 hours per day, or using eye drops to blur the image in the good eye for periods of 4 weeks at a time. The aim is both to avoid the need for patching or eye drops (which are unpopular treatments) and to get an improved visual outcome.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0225
Date of REC Opinion
2 Aug 2016
REC opinion
Further Information Favourable Opinion