BALANCE phase 2a RCT
Research type
Research Study
Full title
Phase 2a two-site randomised controlled trial to determine safety of and adherence with a new ‘Binocularly Balanced Viewing’ treatment for unilateral amblyopia compared with standard treatment in children age 3-8 years.
IRAS ID
214426
Contact name
Annegret Dahlmann-Noor
Contact email
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
“Lazy eye” (amblyopia) is the commonest sight problem in children, affecting about one in 30 children. It is caused by a difference in spectacle prescription between the eyes and/or a squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for years and involve frequent clinic visits.
We have developed an exciting new treatment: children watch customized movies for an hour a day on a hand-held 3D computer-game console. We blur the picture that the good eye sees to match it with what the weaker eye sees. We have tested this approach on 22 children, with an average improvement in vision by three lines on the test chart over 8-24 weeks, which may be faster than with standard treatment. Parents and children we have spoken with like both the idea of research in this area and the engaging nature of this device. We now need to assess how the new treatment compares with standard treatment, but first need to ensure that the new treatment is safe and that families will use it.
In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console with movies, or standard patching/blurring eyedrop treatment. We will monitor adverse events (double vision), change in the balance between the two eyes and in visual acuity over 16 weeks. Parents and children have helped develop this pilot; we will continue this involvement throughout the study. At study completion, we will involve children and parents in deciding how best to communicate our findings on hospital websites, in newsletters, at conferences and in medical journals.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1204
Date of REC Opinion
17 Jul 2018
REC opinion
Favourable Opinion