RECRUITING

Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

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

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Official Title

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Quick Facts

Study Start:2024-07-11
Study Completion:2027-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06380517

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:4 Years to 7 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  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 Contact

Raymond T Kraker, MSPH
CONTACT
813-975-8690
rkraker@jaeb.org
Brooke P Fimbel
CONTACT
813-975-8690
bfimmel@jaeb.org

Principal Investigator

Aparna Raghuram, OD, PhD
STUDY_CHAIR
Boston Children's Hospital/ Harvard Medical School
Kammi Gunton, MD
STUDY_CHAIR
Wills Eye Hospital
Robert Henderson, MS
PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85711
United States
Arkansas Childrens
Little Rock, Arkansas, 72202
United States
Univ. of California- Berkeley
Berkeley, California, 94720
United States
Southern California College of Optometry
Fullerton, California, 92831-1699
United States
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, 90027
United States
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, California, 90095
United States
Stanford University
Palo Alto, California, 94303
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Illinois College of Optometry
Chicago, Illinois, 60616
United States
Progressive Eye Care
Lisle, Illinois, 60532
United States
Indiana School of Optometry
Bloomington, Indiana, 47405
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453
United States
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, 49307
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501
United States
Conestoga Eye
Lancaster, Pennsylvania, 17601
United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
United States
Prisma Health Ophthalmology
Columbia, South Carolina, 29203
United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232-8808
United States
Earl R. Crouch, III
Norfolk, Virginia, 23502-3942
United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
United States
Seattle Children's Hospital, University of Washington
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

  • Aparna Raghuram, OD, PhD, STUDY_CHAIR, Boston Children's Hospital/ Harvard Medical School
  • Kammi Gunton, MD, STUDY_CHAIR, Wills Eye Hospital
  • Robert Henderson, MS, PRINCIPAL_INVESTIGATOR, Jaeb Center for Health Research

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 Date2024-07-11
Study Completion Date2027-05-01

Study Record Updates

Study Start Date2024-07-11
Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

  • Dichoptic
  • Luminopia
  • Patching
  • movie

Additional Relevant MeSH Terms

  • Amblyopia