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Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Sponsor: Luminopia
Summary
Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity. For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-09-01
Completion Date
2026-12-31
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
N/A this is an observational study of Standard of Care
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
Locations (13)
UCSF Benioff Children's Physicians
San Ramon, California, United States
Sansum Clinic
Santa Barbara, California, United States
Okaloosa Ophthalmology
Crestview, Florida, United States
Family Focus Eye Care
Gainsville, Florida, United States
Eye Physicians of Central Florida
Maitland, Florida, United States
Children's Eye Institute of Savannah
Savannah, Georgia, United States
Honolulu Eye Clinic
Honolulu, Hawaii, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Riley Children's Hospital at IU Health
Indianapolis, Indiana, United States
Nevada Eye Physicians
Las Vegas, Nevada, United States
Concord Eye Center
Concord, New Hampshire, United States
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Pediatric Eye Specialist
Fort Worth, Texas, United States