Actively Recruiting

All Genders
ID06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Led by Luminopia · Updated on 2025-09-12

500

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Amblyopia is a common cause of reduced vision in one eye among children and young adults, affecting between 1% to 5% of this population. It often results from untreated differences in vision between the eyes or eye misalignment, and can impact various visual functions including depth perception and reading ability. Researchers are using a patient registry to collect real-world data on Luminopia, an FDA-approved device that offers a new dual action treatment for amblyopia, to understand how it is used by eye care professionals and its effects in everyday practice. This study observes patients who have been treated with Luminopia, a medical device that uses therapeutic software to stimulate vision in the affected eye. The registry collects clinical information over time without altering the standard care these patients receive. By gathering data at multiple points including 3, 6, 12, and 24 months, researchers aim to track changes in visual acuity, stereoacuity, treatment adherence, and treatment duration. Participants provide clinical data through their regular follow-up visits while undergoing Luminopia treatment. Researchers monitor vision improvements and durability of results after stopping treatment using standard clinical assessments. The study also analyzes outcomes based on factors like prior treatments, type and severity of amblyopia, age, and adherence levels. This comprehensive observation will help answer important scientific questions about the long-term real-world use of Luminopia therapy.

CONDITIONS

Brief 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 24 months

Participants who undergo routine care with Luminopia treatment are observed to track changes in visual acuity and adherence over time.

Visits at approximately 3, 6, 12, and 24 months

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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