Status:
COMPLETED
A Patch Free Treatment for Young Children With Amblyopia
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Retina Foundation of the Southwest
McGill University
Conditions:
Amblyopia
Binocular Vision Disorder
Eligibility:
All Genders
36-83 years
Phase:
NA
Brief Summary
The purpose of this study is to test whether a binocular treatment can improve vision and motor function in young children with amblyopia. The proposed treatment is an animation series that has been m...
Detailed Description
This is a prospective study with study sites in Ontario, Canada (University of Waterloo); Quebec, Canada (University of McGill); Texas, United States of America (Retina Foundation of the Southwest); a...
Eligibility Criteria
Inclusion
- Aged 3-5.9 years old (36-83 months at the time of registration)
- Confirmed diagnosis of amblyopia
- Best-corrected visual acuity of 20/32 - 20/100 in the amblyopic eye
- Best-corrected visual acuity of 20/16 - 20/40 in fellow eye for ages 3-4, and 20/16-20/32 for ages 5-5.9
- Interocular difference in visual acuity of 3 lines or greater
- If anisometropic, anisometropia (≥1.00D)
- Wearing glasses for 8+ weeks + no change in VA w/ glasses for 4-6 weeks
- Must be able to experience simultaneous perception when viewing the binocular treatment stimuli with an appropriate interocular contrast offset
- Doctor and parent must be willing to forego patching/drops for 4 week study period
Exclusion
- strabismus
- Diagnosed eye disease or visual disorder other than amblyopia or anisometropia
- \>8 weeks premature
- Diagnosed or suspected developmental delay (eg. learning disability, autism, Down syndrome)
- Diagnosed systemic disease (eg. diabetes, lupus, albinism)
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04086524
Start Date
January 13 2020
End Date
November 30 2023
Last Update
March 12 2024
Active Locations (2)
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1
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
2
Queensland University of Technology
Brisbane, Queesnland, Australia, 4000