RecruitingNot ApplicableNCT05440448
Patch-free Occlusion Therapy
Sponsor
Retina Foundation of the Southwest
Enrollment
68 participants
Start Date
Apr 22, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 3 YearsMax Age: 12 Years
Inclusion Criteria6
- -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 Criteria4
- Prematurity ≥8 wk
- coexisting ocular or systemic disease
- developmental delay
- myopia > -3.00D
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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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05440448
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