Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
ATS24
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
2 other identifiers
interventional
252
1 country
58
Brief 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.
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 Oct 2024
Typical duration for phase_3
58 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
July 23, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedStudy Start
First participant enrolled
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
February 11, 2026
February 1, 2026
2.7 years
July 23, 2024
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in amblyopic eye logMAR distance VA
between randomization and 18 weeks
18 Weeks
Secondary Outcomes (1)
Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ).
18 Weeks
Study Arms (3)
Luminopia Group
EXPERIMENTALdichoptic 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 current optical correction if needed
Vivid Vision Group
EXPERIMENTALdichoptic games using the Vivid Vision headset, prescribed approximately 25 minutes per day (treatment time to complete the day's sessions can be split into shorter sessions totaling about 25 minutes each day) 6 days per week with current optical correction if needed
Continued Optical Correction Group
ACTIVE COMPARATORcontinued full-time optical correction alone if needed
Interventions
Glasses prescribed at investigator discretion
Eligibility Criteria
You may qualify if:
- Age 8 to \<13 years.
- VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
- VA in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters with E-ETDRS).
- VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS).
- Interocular difference ≥ 3 logMAR lines (≥ 15 letters) 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.
- 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).
- ≥1.00 D difference between eyes in SE OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
- +29 more criteria
You may not qualify if:
- Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
- Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.
- Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
- Myopia greater than -6.00D spherical equivalent in either eye.
- Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
- Diplopia more than once per week over the last week prior to enrollment by parental report.
- History of light-induced seizures.
- Known simulator sickness.
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
- Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.
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 (58)
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
University Eye Center at Ketchum Health
Anaheim, California, 92807, United States
Univ. of California- Berkeley
Berkeley, California, 94720, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697, 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
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, 33382, United States
University of South Florida (USF) Eye
Tampa, Florida, 33620, 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
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
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, 49307, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, 49546, United States
Zenith Vision Development Center
Duluth, Minnesota, 55811, United States
University of Minnesota-Minnesota Lions Children's Eye Clinic
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
University of Nebraska Medical Center
Omaha, Nebraska, 68114, 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
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
River View Family Eyecare
Albany, Oregon, 97321, United States
OHSU 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
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141, United States
Storm Eye Institute
Mt. Pleasant, South Carolina, 29464, United States
Southern College of Optometry
Memphis, Tennessee, 38104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Houston - College of Optometry
Houston, Texas, 77204, United States
University of Houston College of Optometry
Houston, Texas, 77204, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marjean T Kulp, OD
Ohio State University
- STUDY CHAIR
Benajmin G Jastrzembski, MD
University of California, Davis
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
July 23, 2024
First Posted
July 29, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
November 1, 2027
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.