Patch-free Occlusion Therapy
Retina Foundation of the Southwest
Summary
The purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.
Description
This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion…
Eligibility
- Age range
- 3–12 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 3-12 years * male and female * strabismic, anisometropic, or combined mechanism amblyopia (visual acuity: 0.3-0.8 logMAR) * interocular visual acuity difference ≥0.3 logMAR * wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart * child's ophthalmologist and family willing to forgo standard patching treatment during the study Exclusion Criteria: * Prematurity ≥8 wk * coexisting ocular or systemic disease * developmental delay * myopia \> -3.00D
Interventions
- DevicePatch-free occlusion therapy
Use of filters in glasses to provide occlusion therapy
- DeviceAdhesive patch
Standard-of-care occlusion therapy with an adhesive patch
Location
- Retina FoundationDallas, Texas