Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Have a diagnosis of amblyopia

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

Locations
United States
California
UCSF Benioff Children's Physicians
RECRUITING
San Ramon
Sansum Clinic
RECRUITING
Santa Barbara
Florida
Okaloosa Ophthalmology
RECRUITING
Crestview
Family Focus Eye Care
RECRUITING
Gainsville
Eye Physicians of Central Florida
RECRUITING
Maitland
Georgia
Children's Eye Institute of Savannah
RECRUITING
Savannah
Hawaii
Honolulu Eye Clinic
RECRUITING
Honolulu
Illinois
Lurie Children's Hospital
RECRUITING
Chicago
Indiana
Riley Children's Hospital at IU Health
RECRUITING
Indianapolis
New Hampshire
Concord Eye Center
RECRUITING
Concord
Nevada
Nevada Eye Physicians
RECRUITING
Las Vegas
Pennsylvania
Children's Hospital Of Philadelphia
RECRUITING
Philadelphia
Texas
Pediatric Eye Specialist
RECRUITING
Fort Worth
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 500
Related Therapeutic Areas
Sponsors
Leads: Luminopia

This content was sourced from clinicaltrials.gov

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