Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
NCT ID: NCT06380517
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
238 participants
INTERVENTIONAL
2024-07-01
2028-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Luminopia Group
watching 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.
Luminopia
dichoptic movies/shows shown through a virtual reality headset
Patching Group
patching 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.
Eye Patch
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye
Interventions
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Luminopia
dichoptic movies/shows shown through a virtual reality headset
Eye Patch
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye
Eligibility Criteria
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Inclusion Criteria
2. 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:
1. VA in the amblyopic eye 20/40 to 20/200 inclusive.
2. 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
3. Interocular difference ≥ 3 logMAR lines (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 (see #7 below).
* 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 spherical equivalent 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: 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 \<0.1 logMAR 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 the Luminopia headset.
8. Participant is willing to continue full-time spectacles/contact lens wear (if needed).
9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.
10. Interpupillary distance of 52mm to 72mm inclusive.
11. Investigator is willing to prescribe Luminopia or patching per protocol.
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.
14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated.
Individuals meeting any of the following criteria will be excluded from study participation.
1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
2. Prism lenses or need of a prism prescription at 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. Previous intraocular or refractive surgery.
6. Known skin reactions to patch or bandage adhesives.
7. 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).
8. Diplopia more than once per week over the last week prior to enrollment by parental report.
9. History of light-induced seizures.
10. 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.
11. Participation in a prior study involving patching for amblyopia
12. 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.
4 Years
7 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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Aparna Raghuram, OD, PhD
Role: STUDY_CHAIR
Boston Children's Hospital/ Harvard Medical School
Kammi Gunton, MD
Role: STUDY_CHAIR
Wills Eye Hospital
Robert Henderson, MS
Role: PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
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
Univ. of California- Berkeley
Berkeley, California, United States
Southern California College of Optometry
Fullerton, California, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, United States
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, 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
Rady Children's Hospital - San Diego Dept of Ophthalmology
San Diego, California, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
University of South Florida (USF) Eye
Tampa, Florida, United States
The Emory Eye Center
Atlanta, Georgia, 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
Specialized Pediatric Eye Care
Beverly, Massachusetts, 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
University of Michigan
Ann Arbor, Michigan, United States
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States
Children's Eye Care PC
West Bloomfield, Michigan, United States
Zenith Vision Development Center
Duluth, Minnesota, United States
University of Minnesota
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
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York, 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
Pediatric Ophthalmology Associates, Inc.
Columbus, 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
Eye Care Associates, Inc.
Poland, Ohio, United States
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
Pennsylvania College of Optometry, Salus at Drexel University
Philadelphia, Pennsylvania, United States
Prisma Health
Columbia, South Carolina, United States
Storm Eye Institute
Mt. Pleasant, South Carolina, United States
Southern College of Optometry
Memphis, Tennessee, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
University of the Incarnate Word
San Antonio, Texas, United States
Earl R. Crouch, III
Norfolk, Virginia, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, United States
Seattle Children's Hospital, University of Washington
Seattle, Washington, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Gundersen Health System
La Crosse, Wisconsin, 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
Jenna Titelbaum, OD
Role: primary
Samiksha Fouzdar Jain, MD
Role: primary
James Bowsher
Role: primary
Earl R. Crouch, III, M.D.
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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ATS23
Identifier Type: -
Identifier Source: org_study_id
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