Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Start Date
7/1/2024
Completion Date
1/1/2028
Summary
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.
Detailed Description
Participants eligible for the study will be randomly allocated (1:1) to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13, and 26-weeks post-randomization. At the 26-week primary outcome visit, participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more, will be offered Luminopia dichoptic therapy and if they accept, followed forward with visits at 39- and 52-weeks post-randomization. The study will end for all other participants.
Eligibility Criteria
Age Range: 4 years to 7 years
Interventions
Luminopia
Eye Patch
Conditions
Locations
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama 35294
United States
Midwestern University Eye Institute
Glendale, Arizona 85308
United States
Phoenix Children's Medical Group - Ophthalmology
Scottsdale, Arizona 85255
United States
University of Arizona
Tucson, Arizona 85711
United States
Arkansas Childrens
Little Rock, Arkansas 72202
United States
McFarland Eye Care Center
Little Rock, Arkansas 72205
United States
Univ. of California- Berkeley
Berkeley, California 94720
United States
Southern California College of Optometry
Fullerton, California 92831-1699
United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California 92697
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
Western University College of Optometry
Pomona, California 91766
United States
University of California, Davis
Sacramento, California 95817
United States
Rady Children's Hospital - San Diego Dept of Ophthalmology
San Diego, California 92123
United States
University of California San Francisco Department of Ophthalmology
San Francisco, California 94143
United States
Yale University
New Haven, Connecticut 06511
United States
University of South Florida (USF) Eye
Tampa, Florida 33620
United States
The Emory Eye Center
Atlanta, Georgia 30322
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
Midwestern University Eye Institute
Downers Grove, Illinois 60515
United States
Progressive Eye Care
Lisle, Illinois 60532
United States
Indiana School of Optometry
Bloomington, Indiana 47405
United States
University of Iowa
Iowa City, Iowa 52242
United States
University of Kansas Dept of Ophthalmology
Prairie Village, Kansas 66208
United States
Greater Baltimore Medical Center
Baltimore, Maryland 21204-5809
United States
Wilmer Eye Institute
Baltimore, Maryland 21287-9028
United States
Specialized Pediatric Eye Care
Beverly, Massachusetts 01915
United States
New England College of Optometry
Boston, Massachusetts 02115
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Boston Children's Hospital Waltham
Boston, Massachusetts 02453
United States
University of Michigan
Ann Arbor, Michigan 48105
United States
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan 49307
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan 49546
United States
Children's Eye Care PC
West Bloomfield, Michigan 48322
United States
Zenith Vision Development Center
Duluth, Minnesota 55811
United States
University of Minnesota
Minneapolis, Minnesota 55454
United States
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota 55905
United States
PineCone Vision Center
Sartell, Minnesota 56377
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
United States
University of Nebraska Medical Center
Omaha, Nebraska 68114
United States
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York 14209
United States
NYU Langone Health
New York, New York 10017
United States
State University of New York, College of Optometry
New York, New York 10036
United States
University of North Carolina
Chapel Hill, North Carolina 27599
United States
Duke University Eye Center
Durham, North Carolina 27710
United States
University of North Dakota
Grand Forks, North Dakota 58202
United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
United States
Cole Eye Institute
Cleveland, Ohio 44195
United States
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio 43205
United States
Ohio State University College of Optometry
Columbus, Ohio 43210-1280
United States
Rainbow Babies and Children's Hospital Dept of Ophth
Mayfield Heights, Ohio 44124
United States
Eye Care Associates, Inc.
Poland, Ohio 44514
United States
Casey Eye Institute
Portland, Oregon 97239
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
Pennsylvania College of Optometry, Salus at Drexel University
Philadelphia, Pennsylvania 19141
United States
Prisma Health
Columbia, South Carolina 29203
United States
Storm Eye Institute
Mt. Pleasant, South Carolina 29464
United States
Southern College of Optometry
Memphis, Tennessee 38104
United States
Vanderbilt Children's Hospital
Nashville, Tennessee 37232-8808
United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas 77030
United States
Texas Tech University Health Science Center
Lubbock, Texas 79430
United States
University of the Incarnate Word
San Antonio, Texas 78209
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
Spokane Eye Clinical Research
Spokane, Washington 99204
United States
Gundersen Health System
La Crosse, Wisconsin 54601
United States