Patch-free Occlusion Therapy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
Retina Foundation
RECRUITING
Dallas
Contact Information
Primary
Eileen E Birch, PhD
ebirch@retinafoundation.org
2143633911
Backup
Reed M Jost, MS
reedjost@retinafoundation.org
2143633911
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 68
Treatments
Experimental: Patch-free occlusion therapy
Active_comparator: Standard-of-care patching with an adhesive patch
Related Therapeutic Areas
Sponsors
Leads: Retina Foundation of the Southwest
Collaborators: National Eye Institute (NEI)