Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
NCT ID: NCT06524882
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
252 participants
INTERVENTIONAL
2024-10-22
2027-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Luminopia Group
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 current optical correction if needed
Luminopia
dichoptic movies/shows shown through a virtual reality headset
Vivid Vision Group
dichoptic 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
Vivid Vision
dichoptic video games played through a virtual reality headset
Continued Optical Correction Group
continued full-time optical correction alone if needed
Optical Correction
Glasses prescribed at investigator discretion
Interventions
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Vivid Vision
dichoptic video games played through a virtual reality headset
Luminopia
dichoptic movies/shows shown through a virtual reality headset
Optical Correction
Glasses prescribed at investigator discretion
Eligibility Criteria
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Inclusion Criteria
2. 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:
1. VA in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters with E-ETDRS).
2. VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS).
3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
1. 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).
2. 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.
3. 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.
4. No more than 2 weeks (cumulative) of prior dichoptic treatment
5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:
* Hypermetropia of 2.50 D or more by SE
* Myopia of amblyopic eye of 0.50D or more SE
* Astigmatism of 1.00D or more
* Anisometropia of more than 0.50D SE
NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
1. Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
* SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes).
* SE must not be under corrected by more than 1.50D SE.
* Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
* Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D.
* Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
2. Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:
* For at least 18 weeks OR until VA stability is documented (defined as \<1-line change by the same testing method measured on 2 consecutive exams at least 9 weeks apart).
* For determining VA stability (non-improvement):
* The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
* The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks.
* NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.
7. Participant is willing to wear a headset.
8. Participant is willing to continue full-time spectacles/contact lens wear (if needed).
9. Interpupillary distance of 52mm to 72mm inclusive.
10. Investigator is willing to prescribe continued spectacles/contact lens correction (if needed) or either dichoptic device per protocol.
11. Participant is willing to accept assignment to either continued spectacles/ contact lens wear alone, dichoptic movies/shows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks.
12. Parent understands the protocol and is willing to accept randomization.
13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff.
14. Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.
Exclusion Criteria
2. Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.
3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
4. Myopia greater than -6.00D spherical equivalent in either eye.
5. 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).
6. Diplopia more than once per week over the last week prior to enrollment by parental report.
7. History of light-induced seizures.
8. Known simulator sickness.
9. 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.
10. 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.
8 Years
12 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Pediatric Eye Disease Investigator Group
NETWORK
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Marjean T Kulp, OD
Role: STUDY_CHAIR
Ohio State University
Benajmin G Jastrzembski, MD
Role: STUDY_CHAIR
University of California, Davis
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Adriana P Grigorian, M.D.
Role: primary
Samiksha Fouzdar Jain, MD
Role: primary
James Bowsher
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ATS24
Identifier Type: -
Identifier Source: org_study_id
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