Status:
RECRUITING
Video Treatment for Amblyopia
Lead Sponsor:
Retina Foundation of the Southwest
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-7 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive ...
Detailed Description
This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. Participants will be refe...
Eligibility Criteria
Inclusion
- aged 3-7 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
- strabismus \>5 pd
- myopia \> -3.00D
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05439200
Start Date
August 23 2023
End Date
June 30 2027
Last Update
January 7 2026
Active Locations (1)
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1
Retina Foundation
Dallas, Texas, United States, 75241