Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
NCT ID: NCT06429280
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-09-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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N/A this is an observational study of Standard of Care
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
Eligibility Criteria
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Inclusion Criteria
* Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Exclusion Criteria
ALL
No
Sponsors
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Luminopia
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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R-AM-1
Identifier Type: -
Identifier Source: org_study_id
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