Recruiting

Occlusion Therapy

Sponsor:

Retina Foundation of the Southwest

Code:

NCT05440448

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Interventions

Patch-free occlusion therapy

Adhesive patch

Study Details

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 adhesive patch and whether this is associated with better adherence to the treatment.

Conditions

Amblyopia

Study ID

NCT05440448

Start date

Apr 22, 2024

Status verified date

Jan, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Prematurity ≥8 wk
  • coexisting ocular or systemic disease
  • developmental delay
  • myopia > -3.00D

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patch-free occlusion therapy

active comparator: Standard-of-care patching with an adhesive patch

Interventions

Patch-free occlusion therapy

Use of filters in glasses to provide occlusion therapy

Adhesive patch

Standard-of-care occlusion therapy 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 and Locations

Central contacts

Eileen E Birch, PhD

2143633911ebirch@retinafoundation.org

Reed M Jost, MS

2143633911reedjost@retinafoundation.org

Locations

Retina Foundation

Recruiting

Dallas, Texas, United States, 75231

Contacts

Reed M Jost, MS

214-363-3911reedjost@retinafoundation.org

ebirch@retinafoundation.org

Principal Investigator:

Eileen E Birch, PhD

More Information

Sponsor

Retina Foundation of the Southwest

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Retina Foundation of the Southwest on 2026-01-07.