Status:
RECRUITING
Using Dichoptic Therapy to Treat Intermittent Exotropia
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Exotropia Intermittent
Eligibility:
All Genders
4-7 years
Phase:
NA
Brief Summary
Intermittent exotropia is difficult to treat. The mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of IXT required at least one re-operation.Patchin...
Detailed Description
Luminopia, a dichoptic therapy device, was approved by the FDA in 2021 for use in amblyopia in children aged 4-7 years. The device was shown to improve vision in the amblyopic eye by lines in three mo...
Eligibility Criteria
Inclusion
- Diagnosed with IXT
- one eye that is their preferred eye
- ages 4-7
- distance control scores of \<= 4
Exclusion
- distance control scores of 5
- patients with visual acuity with vision that is worse in one eye by greater than two lines
- no preferred eye
- patients who would be unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks.
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06529016
Start Date
July 26 2024
End Date
June 1 2026
Last Update
October 8 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298