Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Last updated: May 20, 2024
Sponsor: Luminopia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

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

Clinical Study ID

NCT06429280
R-AM-1
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Have a diagnosis of amblyopia

  • Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks

Exclusion

Exclusion Criteria:

-Have participated in prior Luminopia clinical trials

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: N/A this is an observational study of Standard of Care
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • UCSF Benioff Children's Physicians

    San Ramon, California 94583
    United States

    Active - Recruiting

  • Sansum Clinic

    Santa Barbara, California 93110
    United States

    Active - Recruiting

  • Okaloosa Ophthalmology

    Crestview, Florida 32536
    United States

    Active - Recruiting

  • Family Focus Eye Care

    Gainesville, Florida 32605
    United States

    Active - Recruiting

  • Eye Physicians of Central Florida

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Children's Eye Institute of Savannah

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • Honolulu Eye Clinic

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Lurie Children's Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Riley Children's Hospital at IU Health

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Nevada Eye Physicians

    Las Vegas, Nevada 89149
    United States

    Active - Recruiting

  • Concord Eye Center

    Concord, New Hampshire 03301
    United States

    Active - Recruiting

  • Children's Hospital Of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Pediatric Eye Specialist

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

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