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NCT06429280Recruiting

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Luminopia

Start Date

9/1/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Have a diagnosis of amblyopia * Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks Exclusion Criteria: -Have participated in prior Luminopia clinical trials

Interventions

DEVICE

N/A this is an observational study of Standard of Care

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Conditions

Amblyopia

Locations

UCSF Benioff Children's Physicians

San Ramon, California 94583

United States

Sansum Clinic

Santa Barbara, California 93110

United States

Okaloosa Ophthalmology

Crestview, Florida 32536

United States

Family Focus Eye Care

Gainsville, Florida 32605

United States

Eye Physicians of Central Florida

Maitland, Florida 32751

United States

Children's Eye Institute of Savannah

Savannah, Georgia 31406

United States

Honolulu Eye Clinic

Honolulu, Hawaii 96813

United States

Lurie Children's Hospital

Chicago, Illinois 60611

United States

Riley Children's Hospital at IU Health

Indianapolis, Indiana 46202

United States

Nevada Eye Physicians

Las Vegas, Nevada 89149

United States

Concord Eye Center

Concord, New Hampshire 03301

United States

Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Pediatric Eye Specialist

Fort Worth, Texas 76104

United States