Status:
RECRUITING
Patch-free Occlusion Therapy
Lead Sponsor:
Retina Foundation of the Southwest
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief 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 adhesiv...
Detailed 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 wi...
Eligibility Criteria
Inclusion
- 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
- Prematurity ≥8 wk
- coexisting ocular or systemic disease
- developmental delay
- myopia \> -3.00D
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05440448
Start Date
April 22 2024
End Date
June 30 2028
Last Update
January 7 2026
Active Locations (1)
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1
Retina Foundation
Dallas, Texas, United States, 75231