Luminopia One Amblyopia Vision Improvement Study
- Conditions
- Amblyopia
- Registration Number
- NCT03608150
- Lead Sponsor
- Luminopia
- Brief Summary
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
- Detailed Description
The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- Age 4 to 7 years at the time of consent.
- Amblyopia associated with anisometropia and/or mild strabismus.
- Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
- Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
- Fellow eye BCVA 20/32 or better.
- Interocular difference ≥ 3 logMAR lines.
- Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.
- Atropine treatment in the past 2 weeks.
- Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
- High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
- History of low adherence with amblyopia treatment or light-induced seizures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Best-Corrected Visual Acuity of Fellow Eye 12 weeks Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Best-Corrected Visual Acuity of Amblyopic Eye 12 weeks Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
- Secondary Outcome Measures
Name Time Method Stereoacuity 12 weeks Mean stereoacuity improvement from baseline after 12 weeks.
Adherence 12 weeks Mean adherence with the therapeutic in treatment group.
Best-Corrected Visual Acuity of Amblyopic Eye 8 weeks Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.
Trial Locations
- Locations (21)
UCLA Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
Family Focus Eye Care
🇺🇸Gainesville, Florida, United States
Eye Physicians of Central Florida
🇺🇸Maitland, Florida, United States
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
IU School of Optometry
🇺🇸Bloomington, Indiana, United States
Kids Eye Care of Maryland
🇺🇸Frederick, Maryland, United States
Specialized Pediatric Eye Care
🇺🇸Beverly, Massachusetts, United States
Children's Eye Care of Michigan
🇺🇸Dearborn, Michigan, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
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