Recruiting

Luminopia

Sponsor:

Luminopia

Code:

NCT06429280

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06429280

Start date

Sep 1, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

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

Primary outcome measure

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

Central Contacts and Locations

Locations

UCSF Benioff Children's Physicians

Recruiting

San Ramon, California, United States, 94583

Contacts

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93110

Contacts

Okaloosa Ophthalmology

Recruiting

Crestview, Florida, United States, 32536

Contacts

Family Focus Eye Care

Recruiting

Gainsville, Florida, United States, 32605

Contacts

Eye Physicians of Central Florida

Recruiting

Maitland, Florida, United States, 32751

Contacts

Principal Investigator:

Louis Blumenfeld

Children's Eye Institute of Savannah

Recruiting

Savannah, Georgia, United States, 31406

Contacts

Honolulu Eye Clinic

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Riley Children's Hospital at IU Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Nevada Eye Physicians

Recruiting

Las Vegas, Nevada, United States, 89149

Contacts

Concord Eye Center

Recruiting

Concord, New Hampshire, United States, 03301

Contacts

Children's Hospital Of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Pediatric Eye Specialist

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

More Information

Sponsor

Luminopia

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Luminopia on 2025-09-12.