Summary

Location
at San Ramon, California and other locations
Dates
study started
completion around

Description

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.

Keywords

Amblyopia

Eligibility

You can join if…

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

You CAN'T join if...

-Have participated in prior Luminopia clinical trials

Locations

  • UCSF Benioff Children's Physicians accepting new patients
    San Ramon California 94583 United States
  • Sansum Clinic accepting new patients
    Santa Barbara California 93110 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Luminopia
ID
NCT06429280
Study Type
Observational
Participants
Expecting 500 study participants
Last Updated