Video Treatment for Amblyopia
2 other identifiers
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
January 7, 2026
January 1, 2026
3.4 years
June 17, 2022
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in amblyopic eye visual acuity using a logMAR chart
change in amblyopic eye logMAR visual acuity relative to baseline
6 weeks
Secondary Outcomes (9)
Change in amblyopic eye visual acuity using a logMAR chart
2, 4, 8, and 10 weeks
Change in extent suppression assessed with the W4 test
6 weeks
Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
6 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children -2
6 weeks
Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
6 weeks
- +4 more secondary outcomes
Study Arms (2)
Asynchronous movies
EXPERIMENTALAsynchronous 3D movies
Standard-of-care patching with an adhesive patch
ACTIVE COMPARATORStandard-of-care patching with an adhesive patch
Interventions
3D movies streamed at home for viewing on a handheld lenticular 3D screen
Adhesive patch to cover the fellow eye
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prematurity ≥8 wk
- coexisting ocular or systemic disease
- developmental delay
- strabismus \>5 pd
- myopia \> -3.00D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Eye Institute (NEI)collaborator
- Retina Foundation of the Southwestlead
Study Sites (1)
Retina Foundation
Dallas, Texas, 75241, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Scientist
Study Record Dates
First Submitted
June 17, 2022
First Posted
June 30, 2022
Study Start
August 23, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share