Patch-free Occlusion Therapy

Part of paid clinical trials in Dallas, Texas.

Sponsor
Retina Foundation of the Southwest
Study ID
NCT05440448
Status
Recruiting
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Conditions

  • Amblyopia

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Patch-free occlusion therapy — DEVICE
    Use of filters in glasses to provide occlusion therapy
  • Adhesive patch — DEVICE
    Standard-of-care occlusion therapy with an adhesive patch

Study Details

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.

Key Dates

Start date
Apr 22, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patch-free occlusion therapy
  • Active Comparator: Standard-of-care patching with an adhesive patch

Primary Outcome Measure

Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Retina FoundationDallasTexas75231
Reed M Jost, MS
[email protected]
214-363-3911
[email protected]
Eileen E Birch, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Retina Foundation· Dallas, TX

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