Patch-free Occlusion Therapy
2 other identifiers
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
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
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
January 7, 2026
January 1, 2026
3.8 years
June 17, 2022
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
change in logMAR relative to baseline
12 weeks
Secondary Outcomes (9)
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
6,18, and 24 weeks
Adherence to patching or viewing videos with glasses measured with a sensor
6 and 12 weeks
Proportion of children who have recovered
6 and 12 weeks
Change in extent of suppression assessed with W4 test
6 and 12 weeks
change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
6 and 12 weeks
- +4 more secondary outcomes
Study Arms (2)
Patch-free occlusion therapy
EXPERIMENTALStandard-of-care patching with an adhesive patch
ACTIVE COMPARATORInterventions
Use of filters in glasses to provide occlusion therapy
Standard-of-care occlusion therapy with an adhesive patch
Eligibility Criteria
You may qualify if:
- 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
- myopia \> -3.00D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Retina Foundation of the Southwestlead
- National Eye Institute (NEI)collaborator
Study Sites (1)
Retina Foundation
Dallas, Texas, 75231, 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
April 22, 2024
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share