Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Description

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.

Conditions

Amblyopia

Study Overview

Study Details

Study overview

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.

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Condition
Amblyopia
Intervention / Treatment

-

Contacts and Locations

San Ramon

UCSF Benioff Children's Physicians, San Ramon, California, United States, 94583

Santa Barbara

Sansum Clinic, Santa Barbara, California, United States, 93110

Crestview

Okaloosa Ophthalmology, Crestview, Florida, United States, 32536

Gainesville

Family Focus Eye Care, Gainesville, Florida, United States, 32605

Maitland

Eye Physicians of Central Florida, Maitland, Florida, United States, 32751

Savannah

Children's Eye Institute of Savannah, Savannah, Georgia, United States, 31406

Honolulu

Honolulu Eye Clinic, Honolulu, Hawaii, United States, 96813

Chicago

Lurie Children's Hospital, Chicago, Illinois, United States, 60611

Indianapolis

Riley Children's Hospital at IU Health, Indianapolis, Indiana, United States, 46202

Las Vegas

Nevada Eye Physicians, Las Vegas, Nevada, United States, 89149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Luminopia,

Study Record Dates

2026-12-01