Video Treatment for Amblyopia

The purpose of this study is to determine whether viewing asynchronous movies 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 treatment.

Study Overview

• Status: Recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Device: Asynchronous 3D movies; Device: Patching

Detailed Description

This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. 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 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.

The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, 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 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).

• Study Type: Interventional
• Enrollment (Estimated): 44
• 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, 75241
      • Recruiting
      • Retina Foundation
      • Contact: Reed M Jost, MS; Phone Number: 113 214-363-3911; Email: reedjiost@retinafoundation.org
      • Contact: Email: ebirch@retinafoundation.org
      • Principal Investigator: Eileen E Birch, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 3-7 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
• strabismus >5 pd
• 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: Asynchronous movies; Asynchronous 3D movies	Device: Asynchronous 3D movies; 3D movies streamed at home for viewing on a handheld lenticular 3D screen
Active Comparator: Standard-of-care patching with an adhesive patch	Device: Patching; Adhesive patch to cover the fellow eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in amblyopic eye visual acuity using a logMAR chart	change in amblyopic eye logMAR visual acuity relative to baseline	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in extent suppression assessed with the W4 test	change in log deg assessed with the W4 test relative to baseline	6 weeks
Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test	change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test	6 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children -2	change in standard scores obtained with the Movement Assessment Battery for Children -2 (MABC-2; (normed and scaled 0-19, with 10 as an average score, 5-6 as "at risk", and <5 as "significant impairment")	6 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)	6 weeks
Change in quality of life assessed 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)	6 weeks
Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data	cumulative hours of treatment with the patch objectively monitored temperature sensitive Theramon sensor or with movie viewing by monitoring the streaming logs	2,4, and 6 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 weeks
Change in amblyopic eye visual acuity using a logMAR chart	change in amblyopic eye logMAR visual acuity relative to baseline at 2, 8, and 10 weeks	2, 8, and 10 weeks
Proportion of children who have recovered	proportion of children who attain amblyopic eye visual acuity of at least 0.1 logMAR	2, 6, 8, and 10 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027

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 (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 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: RFSW113B; 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