NCT06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Luminopia · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	N/A this is an observational study of Standard of Care	Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-24
• Last updated: 2025-09-12

Locations

13 sites across 1 country: United States