Status:
RECRUITING
Binocular Amblyopia Treatment
Lead Sponsor:
Retina Foundation of the Southwest
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
4-10 years
Phase:
NA
Brief Summary
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.
Detailed Description
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i....
Eligibility Criteria
Inclusion
- age 4-10 y
- male and female
- strabismic, anisometropic, or combined mechanism amblyopia
- amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
- fellow eye best-corrected visual acuity ≤0.1 logMAR
- interocular visual acuity difference ≥0.3 logMAR
- wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits
- 4 weeks apart.
- child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
- parent's informed consent
- child must demonstrate understanding and ability to play binocular games
Exclusion
- prematurity ≥8 weeks
- coexisting ocular or systemic disease
- developmental delay
- strabismus \>5pd
- any binocular amblyopia treatment in the past 3 months
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03288948
Start Date
August 31 2017
End Date
December 31 2025
Last Update
January 27 2025
Active Locations (1)
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1
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231