Study Results
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View full resultsBasic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2019-01-16
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapeutic Group
Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.
Luminopia One
Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
Control Group
Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.
Refractive Correction
Standard of care refractive correction (ex. spectacles)
Interventions
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Luminopia One
Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
Refractive Correction
Standard of care refractive correction (ex. spectacles)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
4 Years
7 Years
ALL
No
Sponsors
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Luminopia
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Xiao
Role: STUDY_DIRECTOR
Luminopia
Locations
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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
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU College of Optometry
Columbus, Ohio, United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States
Conestoga Eye
Lancaster, Pennsylvania, United States
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Tri-County Eye Physicians
Southampton, Pennsylvania, United States
Houston Eye Associates
Houston, Texas, United States
Texas Children's Hospital (BCM)
Houston, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Rocky Mountain Eye Care
Salt Lake City, Utah, United States
Virginia Pediatric Eye Center
Virginia Beach, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C-AM-2
Identifier Type: -
Identifier Source: org_study_id
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