Status:
COMPLETED
Luminopia One Pilot Study
Lead Sponsor:
Luminopia
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Amblyopia
Eligibility:
All Genders
4-12 years
Phase:
NA
Brief Summary
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia popula...
Eligibility Criteria
Inclusion
- Major Eligibility Criteria:
- Age 4 to \<8 years (phase 1) or age 4 to \<13 years (phase 2)
- Monocular amblyopia associated with anisometropia, strabismus or both combined
- Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)
- Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)
- Interocular BCVA difference ≥3 lines (≥0.3 logMAR)
- Visual acuity stability in current refractive correction (phase 2)
- Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)
Exclusion
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02782117
Start Date
August 1 2017
End Date
February 6 2019
Last Update
July 9 2020
Active Locations (9)
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1
Eye Physicians of Central Florida
Maitland, Florida, United States, 32751
2
Wheaton Eye Clinic
Chicago, Illinois, United States, 60187
3
Indiana University
Bloomington, Indiana, United States, 47405
4
Kids Eye Care of Maryland
Frederick, Maryland, United States, 21703