Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

NCT ID: NCT06429280

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amblyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luminopia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Benioff Children's Physicians

San Ramon, California, United States

Site Status RECRUITING

Sansum Clinic

Santa Barbara, California, United States

Site Status RECRUITING

Okaloosa Ophthalmology

Crestview, Florida, United States

Site Status RECRUITING

Family Focus Eye Care

Gainsville, Florida, United States

Site Status RECRUITING

Eye Physicians of Central Florida

Maitland, Florida, United States

Site Status RECRUITING

Children's Eye Institute of Savannah

Savannah, Georgia, United States

Site Status RECRUITING

Honolulu Eye Clinic

Honolulu, Hawaii, United States

Site Status RECRUITING

Lurie Children's Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Riley Children's Hospital at IU Health

Indianapolis, Indiana, United States

Site Status RECRUITING

Nevada Eye Physicians

Las Vegas, Nevada, United States

Site Status RECRUITING

Concord Eye Center

Concord, New Hampshire, United States

Site Status RECRUITING

Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Pediatric Eye Specialist

Fort Worth, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Endri Angjeli

Role: primary

9788067080

Other Identifiers

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R-AM-1

Identifier Type: -

Identifier Source: org_study_id

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