Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Recruiting now

Conditions studied: Amblyopia

In brief

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.

Key facts

Study ID

NCT06429280

Run by

Luminopia

People needed

500

Starts

2023-09-01

Expected to finish

2026-12-31

Last updated by the study team

2025-09-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UCSF Benioff Children's Physicians — San Ramon, California, United States (enrolling)
• Sansum Clinic — Santa Barbara, California, United States (enrolling)
• Okaloosa Ophthalmology — Crestview, Florida, United States (enrolling)
• Family Focus Eye Care — Gainsville, Florida, United States (enrolling)
• Eye Physicians of Central Florida — Maitland, Florida, United States (enrolling)
• Children's Eye Institute of Savannah — Savannah, Georgia, United States (enrolling)
• Honolulu Eye Clinic — Honolulu, Hawaii, United States (enrolling)
• Lurie Children's Hospital — Chicago, Illinois, United States (enrolling)
• Riley Children's Hospital at IU Health — Indianapolis, Indiana, United States (enrolling)
• Nevada Eye Physicians — Las Vegas, Nevada, United States (enrolling)
• Concord Eye Center — Concord, New Hampshire, United States (enrolling)
• Children's Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Pediatric Eye Specialist — Fort Worth, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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