Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

NCT06429280 | Recruiting

• 1 other identifier: R-AM-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (5)

• Change in Visual Acuity from baseline to consecutive visits

  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

  Duration of Visual Acuity treatment and number of follow-up visits

  3, 6,12, 24 months

• Durability of Visual Acuity results post-treatment cessation

  Durability of Visual Acuity results post-treatment cessation

  3, 6,12, 24 months

• Adherence with Luminopia treatment

  Adherence with Luminopia treatment

  3, 6,12, 24 months

• Change in Stereoacuity from baseline to consecutive visits

  Change in Stereoacuity from baseline to consecutive visits

  3, 6,12, 24 months

Secondary Outcomes (7)

• 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

  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

  3, 6,12, 24 months

• Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)

  3, 6,12, 24 months

Interventions

N/A this is an observational study of Standard of Care DEVICE

Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of Amblyopia

You may qualify if:

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

You may not qualify if:

• Have participated in prior Luminopia clinical trials

Sponsors & Collaborators

• Luminopia: lead

Study Sites (13)

UCSF Benioff Children's Physicians

San Ramon, California, 94583, United States

RECRUITING

Sansum Clinic

Santa Barbara, California, 93110, United States

RECRUITING

Okaloosa Ophthalmology

Crestview, Florida, 32536, United States

RECRUITING

Family Focus Eye Care

Gainsville, Florida, 32605, United States

RECRUITING

Eye Physicians of Central Florida

Maitland, Florida, 32751, United States

RECRUITING

Children's Eye Institute of Savannah

Savannah, Georgia, 31406, United States

RECRUITING

Honolulu Eye Clinic

Honolulu, Hawaii, 96813, United States

RECRUITING

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Riley Children's Hospital at IU Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Nevada Eye Physicians

Las Vegas, Nevada, 89149, United States

RECRUITING

Concord Eye Center

Concord, New Hampshire, 03301, United States

RECRUITING

Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pediatric Eye Specialist

Fort Worth, Texas, 76104, United States

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: May 24, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)