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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
INTERVENTION: There are two study arms: Refractive Adaptation Group (n=173): A period of 18 weeks glasses wearing (i.e. RA) will be followed by a period of 24 weeks combined patching (10hrs/day, 6 days/week) and glasses wearing. Early Patching Group (n=173): A period of 3 weeks glasses wearing will be followed by a period of 24 weeks combined patching (10hrs/day, 6 days/week) and glasses wearing. Participants will have an initial full ophthalmologist examination including cycloplegic refraction and will be examined subsequently at 6 weekly intervals with visual acuity measurements. CONDITION: Amblyopia ; Eye Diseases ; Amblyopia PRIMARY OUTCOME: Number 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: 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; 2. To estimate the levels of compliance to glasses and patch wearing; 3. To explore the relationship between duration of glasses wearing and patching and improvement in vision; 4. To explore whether anisometropes respond better to RA compared to strabismus/mixed patients.; 5. To explore whether electronic monitoring influences compliance and visual outcomes; 6. Ascertain opinions from carers and children about the study treatment study through a questionnaire given during and on completion of the study 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
Epistemonikos ID: 003fbc5f6f905ada29614e2df35c49437a8c21bb
First added on: Aug 22, 2024