Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
ATS23
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
2 other identifiers
interventional
238
1 country
73
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2024
Typical duration for phase_3
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
February 11, 2026
February 1, 2026
3 years
April 18, 2024
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
26 Weeks
Study Arms (2)
Luminopia Group
EXPERIMENTALwatching dichoptic movies/shows wearing the Luminopia headset prescribed 1 hour per day (treatment time can be split into shorter sessions totaling 1 hour each day) 6 days a week with optical correction, if needed.
Patching Group
ACTIVE COMPARATORpatching of the fellow eye 2 hours per day (treatment time can be split into shorter sessions totaling 2 hours each day) 7 days per week with optical correction, if needed.
Interventions
Eligibility Criteria
You may qualify if:
- Age 4 to 7 years.
- Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
- VA in the amblyopic eye 20/40 to 20/200 inclusive.
- Age-normal VA in the fellow eye:44,45
- 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better
- Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
- Criteria for strabismic amblyopia: At least one of the following must be met:
- Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below).
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
- Criteria for anisometropia: At least one of the following criteria must be met:
- ≥1.00 D difference between eyes in spherical equivalent (SE).
- ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
- Criteria for combined-mechanism: Both of the following criteria must be met:
- A criterion for strabismus is met (see above).
- +42 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
- Pediatric Eye Disease Investigator Groupcollaborator
Study Sites (73)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aparna Raghuram, OD, PhD
Boston Children's Hospital/ Harvard Medical School
- STUDY CHAIR
Kammi Gunton, MD
Wills Eye Hospital
- PRINCIPAL INVESTIGATOR
Robert Henderson, MS
Jaeb Center for Health Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2024
First Posted
April 24, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available after publication.
- Access Criteria
- Users accessing the data must enter an email address.
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.