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Recruiting NCT06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

— Observational Amblyopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N/A this is an observational study of Standard of Care.
Who it may be relevant to
Registry conditions: Amblyopia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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 measures

  • 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]
Secondary outcome measures (7)
  • Visual Acuity analyses will also be conducted by Prior Treatment [Time frame: 3, 6,12, 24 months]
  • Visual Acuity analyses will also be conducted by Amblyopia Type [Time frame: 3, 6,12, 24 months]
  • Visual Acuity Analyses will also be conducted by Age [Time frame: 3, 6,12, 24 months]
  • Visual Acuity analyses will also be conducted by Baseline Angle of Deviation [Time frame: 3, 6,12, 24 months]
  • Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity) [Time frame: 3, 6,12, 24 months]
  • Visual Acuity analyses will also be conducted by Adherence to Treatment [Time frame: 3, 6,12, 24 months]
  • Visual Acuity Analyses will also be conducted by Prescribed Dose [Time frame: 3, 6,12, 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 13 centers
  • UCSF Benioff Children's Physicians — San Ramon
  • Sansum Clinic — Santa Barbara
  • Okaloosa Ophthalmology — Crestview
  • Family Focus Eye Care — Gainsville
  • Eye Physicians of Central Florida — Maitland
  • Children's Eye Institute of Savannah — Savannah
  • Honolulu Eye Clinic — Honolulu
  • Lurie Children's Hospital — Chicago
  • … and 5 more centers

Identifiers

NCT: NCT06429280 · R-AM-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗