Binocular amblyopia therapeutic software proof of concept study
Research type
Research Study
Full title
A 52 week randomised, single-masked, multicenter proof of concept study of binocular videogames versus patching for amblyopia in children 4-7 years of age with an open-label substudy of binocular videogames in children 8-12 years of age
IRAS ID
295347
Contact name
Annegret Dahlmann-Noor
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 15 days
Research summary
Amblyopia (known as lazy eye) is the most common cause of monocular (one eye) visual loss in children, affecting 1.3%-3.6% of children. Consequences of not identifying and treating amblyopia early include permanent visual impairment, adverse effects on school performance, poor fine motor skills, social interactions, and self-image.
The current standard of care treatment for amblyopia includes, refractive correction (optical treatment), targeting the stronger (fellow) eye through patching or cycloplegic (blurring) drops to promote usage of the amblyopic (weaker) eye.
This is a study involving a medical device comprising of a computer tablet, with two interactive games – Dig Rush/Monster Burner) and a pair of 3D glasses. The main purpose of the study is to determine if the device has medical device functionality and provides better efficacy than the current standard of care (SoC) which is patching of the non-amblyopic eye. Children aged 4 to 7 years diagnosed with amblyopia will either play video games (1 hour per day for 8-12 weeks) or wear an eye patch (2 hours per day for 16 weeks - standard of care) during a treatment period in this study. Children will visit the research site 4 times during the treatment period and once again after 6 months before completing the study with a 12 month visit follow up. The treatment will be allocated at random on a 1 to 1 basis.
In Part B (open label sub-study), children aged 8 to 12 years months will be enrolled to play binocular video games 1 hour a day over 8 weeks to provide efficacy data in support of a decision to further develop of this medical device for the treatment for amblyopia in a broader age group.Up to 3 hospital sites in the UK will enrol up to 20 patients in the study. A total of 95 children will be recruited worldwide.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0608
Date of REC Opinion
16 Dec 2021
REC opinion
Further Information Favourable Opinion