Actively Recruiting

All Genders
NCT06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Led by Luminopia · Updated on 2025-09-12

500

Participants Needed

13

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a diagnosis of amblyopia
  • Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Not Eligible

You will not qualify if you...

  • Have participated in prior Luminopia clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

UCSF Benioff Children's Physicians

San Ramon, California, United States, 94583

Actively Recruiting

2

Sansum Clinic

Santa Barbara, California, United States, 93110

Actively Recruiting

3

Okaloosa Ophthalmology

Crestview, Florida, United States, 32536

Actively Recruiting

4

Family Focus Eye Care

Gainsville, Florida, United States, 32605

Actively Recruiting

5

Eye Physicians of Central Florida

Maitland, Florida, United States, 32751

Actively Recruiting

6

Children's Eye Institute of Savannah

Savannah, Georgia, United States, 31406

Actively Recruiting

7

Honolulu Eye Clinic

Honolulu, Hawaii, United States, 96813

Actively Recruiting

8

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

9

Riley Children's Hospital at IU Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

10

Nevada Eye Physicians

Las Vegas, Nevada, United States, 89149

Actively Recruiting

11

Concord Eye Center

Concord, New Hampshire, United States, 03301

Actively Recruiting

12

Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

13

Pediatric Eye Specialist

Fort Worth, Texas, United States, 76104

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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