Patch-free Occlusion Therapy

NCT ID: NCT05440448

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2028-06-30

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.

Detailed Description

This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.

Children will participate in their assigned occlusion therapy at home for 12 weeks (primary outcome). Adherence will be objectively monitored with a Theramon sensor. Vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. The patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. Children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks.

The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. Secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 and 12 weeks visit and 95% CIs (at 6 and 12 weeks), comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 12 and 24 weeks for the patch-free group (12, 18, and 24 weeks means and 95% CIs).

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patch-free occlusion therapy

Group Type: EXPERIMENTAL

Patch-free occlusion therapy

Intervention Type: DEVICE

Use of filters in glasses to provide occlusion therapy

Standard-of-care patching with an adhesive patch

Group Type: ACTIVE_COMPARATOR

Adhesive patch

Intervention Type: DEVICE

Standard-of-care occlusion therapy with an adhesive patch

Interventions

Patch-free occlusion therapy

Use of filters in glasses to provide occlusion therapy

Intervention Type: DEVICE

Adhesive patch

Standard-of-care occlusion therapy with an adhesive patch

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Retina Foundation of the Southwest

OTHER

Sponsor Role: lead

Responsible Party

Eileen Birch

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Retina Foundation

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eileen E Birch, PhD

Role: CONTACT

ebirch@retinafoundation.org

2143633911 ext. 113

Reed M Jost, MS

Role: CONTACT

reedjost@retinafoundation.org

2143633911 ext. 113

Facility Contacts

Reed M Jost, MS

Role: primary

reedjost@retinafoundation.org

214-363-3911 ext. 113

Role: backup

ebirch@retinafoundation.org

Other Identifiers

R01EY022313

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RFSW113A

Identifier Type: -

Identifier Source: org_study_id