RecruitingNCT06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment


Sponsor

Luminopia

Enrollment

500 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria2

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

Exclusion Criteria1

  • Have participated in prior Luminopia clinical trials

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Interventions

DEVICEN/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

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NCT06429280


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