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RECRUITING
NCT06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Sponsor: Luminopia

View on ClinicalTrials.gov

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

DEVICE

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