RECRUITING

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Quick Facts

Study Start:2023-09-01
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06429280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of amblyopia
  2. * Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

UCSF Benioff Children's Physicians
San Ramon, California, 94583
United States
Sansum Clinic
Santa Barbara, California, 93110
United States
Okaloosa Ophthalmology
Crestview, Florida, 32536
United States
Family Focus Eye Care
Gainesville, Florida, 32605
United States
Eye Physicians of Central Florida
Maitland, Florida, 32751
United States
Children's Eye Institute of Savannah
Savannah, Georgia, 31406
United States
Honolulu Eye Clinic
Honolulu, Hawaii, 96813
United States
Lurie Children's Hospital
Chicago, Illinois, 60611
United States
Riley Children's Hospital at IU Health
Indianapolis, Indiana, 46202
United States
Nevada Eye Physicians
Las Vegas, Nevada, 89149
United States
Concord Eye Center
Concord, New Hampshire, 03301
United States
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Pediatric Eye Specialist
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: Luminopia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Amblyopia