Patch-free Occlusion Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Device: Patch-free occlusion therapy; Device: Adhesive patch

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).

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eileen E Birch, PhD; Phone Number: 113 2143633911; Email: ebirch@retinafoundation.org
• Study Contact Backup: Name: Reed M Jost, MS; Phone Number: 113 2143633911; Email: reedjost@retinafoundation.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Retina Foundation
      • Contact: Email: ebirch@retinafoundation.org
      • Principal Investigator: Eileen E Birch, PhD
      • Contact: Reed M Jost, MS; Phone Number: 113 214-363-3911; Email: reedjost@retinafoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patch-free occlusion therapy	Device: Patch-free occlusion therapy; Use of filters in glasses to provide occlusion therapy
Active Comparator: Standard-of-care patching with an adhesive patch	Device: Adhesive patch; Standard-of-care occlusion therapy with an adhesive patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart	change in logMAR relative to baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart	change in logMAR relative to baseline	6,18, and 24 weeks
Adherence to patching or viewing videos with glasses measured with a sensor	cumulative hours of treatment with the patch or glasses used to watch videos objectively monitored with the skin temperature sensitive Theramon sensor	6 and 12 weeks
Proportion of children who have recovered	Proportion of children who attain amblyopic eye visual acuity of 0.1 logMAR or better	6 and 12 weeks
Change in extent of suppression assessed with W4 test	changes in log deg measure with W4 test	6 and 12 weeks
change in stereoacuity assessed with the Randot Preschool Stereoacuity Test	change in log arcsec	6 and 12 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children-2	change in Movement Assessment Battery for Children-2 (MABC-2) standard scores relative to baseline (normed and scaled 0-19 for worst to best, with 10=average, 5-6 = "at risk", and <5 = "significant impairment")	12 weeks
Change in self-perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children	change in domain scores of the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (standard scores scaled to range from 0 to 100 for worst to best)	12 weeks
Improvement in quality of life assesses with the Pediatric Eye Questionnaire	change in domain scores of the Pediatric Eye Questionnaire (PedEyeQ; Rasch-calibrated and scaled to score from 0 to 100 for worst to best)	12 weeks
Change in depth of suppression assessed with the contrast balance index	change in contrast balance index (ratio of amblyopic eye to fellow eye contrast needed to overcome suppression	6 and 12 weeks

Collaborators and Investigators

• Sponsor: Retina Foundation of the Southwest
• Collaborators: National Eye Institute (NEI)

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Amblyopia
• Other Study ID Numbers: RFSW113A; R01EY022313 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No