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RECRUITING
NCT06524882
PHASE3

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

Summary

Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.

Official title: A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Key Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2024-10-22

Completion Date

2027-11-01

Last Updated

2026-02-11

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Vivid Vision

dichoptic video games played through a virtual reality headset

DEVICE

Luminopia

dichoptic movies/shows shown through a virtual reality headset

DEVICE

Optical Correction

Glasses prescribed at investigator discretion

Locations (58)

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, United States

Midwestern University Eye Institute

Glendale, Arizona, United States

Phoenix Children's Medical Group - Ophthalmology

Scottsdale, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Arkansas Childrens

Little Rock, Arkansas, United States

McFarland Eye Care Center

Little Rock, Arkansas, United States

University Eye Center at Ketchum Health

Anaheim, California, United States

Univ. of California- Berkeley

Berkeley, California, United States

Univ of California, Irvine- Gavin Herbert Eye Institute

Irvine, California, United States

Stanford University

Palo Alto, California, United States

Western University College of Optometry

Pomona, California, United States

University of California, Davis

Sacramento, California, United States

University of California San Francisco Department of Ophthalmology

San Francisco, California, United States

Nova Southeastern University College of Optometry, The Eye Institute

Fort Lauderdale, Florida, United States

University of South Florida (USF) Eye

Tampa, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Illinois College of Optometry

Chicago, Illinois, United States

Midwestern University Eye Institute

Downers Grove, Illinois, United States

Progressive Eye Care

Lisle, Illinois, United States

Indiana School of Optometry

Bloomington, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Dept of Ophthalmology

Prairie Village, Kansas, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Wilmer Eye Institute

Baltimore, Maryland, United States

New England College of Optometry

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Boston Children's Hospital Waltham

Boston, Massachusetts, United States

Michigan College of Optometry at Ferris State Univ

Big Rapids, Michigan, United States

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan, United States

Zenith Vision Development Center

Duluth, Minnesota, United States

University of Minnesota-Minnesota Lions Children's Eye Clinic

Minneapolis, Minnesota, United States

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, United States

PineCone Vision Center

Sartell, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYU Langone Health

New York, New York, United States

State University of New York, College of Optometry

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University Eye Center

Durham, North Carolina, United States

University of North Dakota

Grand Forks, North Dakota, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Cole Eye Institute

Cleveland, Ohio, United States

Ohio State University College of Optometry

Columbus, Ohio, United States

Rainbow Babies and Children's Hospital Dept of Ophth

Mayfield Heights, Ohio, United States

River View Family Eyecare

Albany, Oregon, United States

OHSU Casey Eye Institute

Portland, Oregon, United States

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, United States

Conestoga Eye

Lancaster, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Salus University/Pennsylvania College of Optometry

Philadelphia, Pennsylvania, United States

Storm Eye Institute

Mt. Pleasant, South Carolina, United States

Southern College of Optometry

Memphis, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

University of Houston - College of Optometry

Houston, Texas, United States

University of Houston College of Optometry

Houston, Texas, United States

San Antonio Eye Center

San Antonio, Texas, United States

Virginia Pediatric Eye Center

Norfolk, Virginia, United States

Spokane Eye Clinical Research

Spokane, Washington, United States