KOALA study (Kids with Occlusion therapy for AmbLyopiA), Version 1
Research type
Research Study
Full title
Neural Changes Following Occlusion Therapy in Amblyopia
IRAS ID
324997
Contact name
Holly Bridge
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Amblyopia (also known as ‘lazy eye’) is a visual impairment that affects the visual part of the brain; it leads to vision loss in approximately 3.6% of people in the UK. Amblyopia is commonly treated using ‘Occlusion Therapy’ where the stronger eye is covered to force the weaker ‘lazy’ eye to work. Occlusion therapy is generally effective until the age of 8 but does not work for all young children. To understand the variation in response to Occlusion Therapy, we must understand how the treatment changes the brain.
We will recruit 35 4–8 year-old patients with Amblyopia who are about to begin standard NHS Occlusion Therapy, and 35 age and sex matched controls with normal vision. Children with Amblyopia will be pre-screened by an orthoptist to confirm their diagnosis, and controls will be pre-screened by researchers to make sure they have normal vision. Then all participants will come to WIN-FMRIB (Wellcome Centre for Integrative Neuroimaging- Oxford Centre for Functional MRI of the Brain) for MRI (Magnetic Resonance Imaging) scans and eye tests. The MRI will investigate neural structure, activity, connectivity, and neurochemistry. The eye tests will determine the acuity and contrast sensitivity of each eye, and the child’s binocular stereopsis. Children with Amblyopia will then begin 6 months of NHS standard treatment Occlusion Therapy. We will measure compliance using an ‘Occlusion Dose Monitor’. After 6 months, all participants will repeat the MRI scans and eye tests. We will then analyse how the brain changes with Occlusion Therapy, and how these changes vary with the amount of improvement on eye tests. We hope these findings will lead to better Amblyopia treatments in the future.
This research is based at WIN-FMRIB and is funded by the Medical Research Council (MRC) and the Royal Society.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0228
Date of REC Opinion
30 Nov 2023
REC opinion
Further Information Favourable Opinion