Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

September 5, 2025 updated by: Luminopia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Ramon, California, United States, 94583
        • Recruiting
        • UCSF Benioff Children's Physicians
        • Contact:
      • Santa Barbara, California, United States, 93110
        • Recruiting
        • Sansum Clinic
        • Contact:
    • Florida
      • Crestview, Florida, United States, 32536
        • Recruiting
        • Okaloosa Ophthalmology
        • Contact:
      • Gainsville, Florida, United States, 32605
        • Recruiting
        • Family Focus Eye Care
        • Contact:
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Eye Physicians of Central Florida
        • Principal Investigator:
          • Louis Blumenfeld
        • Contact:
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Children's Eye Institute of Savannah
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Honolulu Eye Clinic
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Hospital at IU Health
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89149
        • Recruiting
        • Nevada Eye Physicians
        • Contact:
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Recruiting
        • Concord Eye Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Pediatric Eye Specialist
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a diagnosis of Amblyopia

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Have participated in prior Luminopia clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Acuity from baseline to consecutive visits
Time Frame: 3, 6,12, 24 months
Change in Visual Acuity from baseline to consecutive visits
3, 6,12, 24 months
Duration of Visual Acuity treatment and number of follow-up visits
Time Frame: 3, 6,12, 24 months
Duration of Visual Acuity treatment and number of follow-up visits
3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
Time Frame: 3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
3, 6,12, 24 months
Adherence with Luminopia treatment
Time Frame: 3, 6,12, 24 months
Adherence with Luminopia treatment
3, 6,12, 24 months
Change in Stereoacuity from baseline to consecutive visits
Time Frame: 3, 6,12, 24 months
Change in Stereoacuity from baseline to consecutive visits
3, 6,12, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity analyses will also be conducted by Prior Treatment
Time Frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Prior Treatment
3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Amblyopia Type
Time Frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Amblyopia Type
3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Age
Time Frame: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Age
3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
Time Frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
Time Frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Adherence to Treatment
Time Frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Adherence to Treatment
3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Prescribed Dose
Time Frame: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Prescribed Dose
3, 6,12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luminopia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-AM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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