EuPatch (European Paediatric Amblyopia Treatment Study for Children): the role of glasses wearing in amblyopia treatment

Not Applicable

Completed

Conditions: Amblyopia
Eye Diseases

Registration Number: ISRCTN51712593

Lead Sponsor: niversity of Leicester (UK)

Brief Summary: 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38704172/ (added 07/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 341

Inclusion Criteria

1. Children (aged 3 to 8 years) with newly detected amblyopia (difference of = 0.3 LogMAR visual acuity between eyes)
2. A clinically significant refractive error (= 1.5D in at least 1 eye or 1D difference between the two eyes)
3. Able to perform the visual acuity test

Exclusion Criteria

1. Children without amblyopia as defined above or with amblyopia as defined above but with other ophthalmic or neurological diseases, or premature children
2. Bilateral amblyopia (vision of better eye corrected visual acuity > 0.2 LogMAR) is also an exclusion criterion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of children successfully treated after 720 hours of prescribed patching over 12 weeks following an initial period of either 3 weeks or 18 weeks glasses wearing prior to patching therapy

Secondary Outcome Measures

Name	Time	Method
1. To compare the number of patients successfully resolved in = 1080 hours of prescribed patching over 18 weeks, and in = 1440 hours over 24 weeks. Where possible we will also compare the two groups in terms of final visual outcome, total duration of treatment and total amount of patching required<br>2. To estimate the levels of compliance to glasses and patch wearing<br>3. To explore the relationship between duration of glasses wearing and patching and improvement in vision<br>4. To explore whether anisometropes respond better to RA compared to strabismus/mixed patients.<br>5. To explore whether electronic monitoring influences compliance and visual outcomes<br>6. Ascertain opinions from carers and children about the study treatment study through a questionnaire given during and on completion of the study