Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)

February 9, 2026 updated by: Jaeb Center for Health Research

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

238

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raymond T Kraker, MSPH
  • Phone Number: 813-975-8690
  • Email: rkraker@jaeb.org

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • UAB Pediatric Eye Care; Birmingham Health Care
        • Principal Investigator:
          • Kristine Hopkins, O.D.
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Recruiting
        • Midwestern University Eye Institute
        • Contact:
        • Sub-Investigator:
          • Christina A Esposito, OD
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Phoenix Children's Medical Group - Ophthalmology
        • Contact:
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • University of Arizona
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Childrens
        • Contact:
          • Adriana P Grigorian, M.D.
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • McFarland Eye Care Center
        • Contact:
    • California
      • Berkeley, California, United States, 94720
        • Recruiting
        • Univ. of California- Berkeley
        • Contact:
      • Fullerton, California, United States, 92831-1699
        • Recruiting
        • Southern California College of Optometry
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Silvia Han, OD
      • Irvine, California, United States, 92697
        • Recruiting
        • Univ of California, Irvine- Gavin Herbert Eye Institute
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Jules Stein Eye Institute at the University of California, Los Angeles
        • Contact:
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles (CHLA)
        • Contact:
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Stanford University
        • Contact:
      • Pomona, California, United States, 91766
        • Recruiting
        • Western University College of Optometry
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital - San Diego Dept of Ophthalmology
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco Department of Ophthalmology
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida (USF) Eye
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • The Emory Eye Center
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Hawke H Yoon, MD
        • Sub-Investigator:
          • Safa Rahmani, MD
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Illinois College of Optometry
        • Contact:
          • Yi Pang, OD, PhD
          • Phone Number: 312-949-7287
          • Email: ypang@ico.edu
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Midwestern University Eye Institute
        • Contact:
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Progressive Eye Care
        • Contact:
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Recruiting
        • Indiana School of Optometry
        • Contact:
          • Katie W. Connolly, O.D.
          • Phone Number: 812-856-0976
          • Email: ksconnol@iu.edu
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Recruiting
        • University of Kansas Dept of Ophthalmology
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21204-5809
        • Recruiting
        • Greater Baltimore Medical Center
        • Contact:
      • Baltimore, Maryland, United States, 21287-9028
        • Recruiting
        • Wilmer Eye Institute
        • Contact:
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Jenna Titelbaum, OD
          • Phone Number: 617-414-2020
      • Boston, Massachusetts, United States, 02453
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • New England College of Optometry
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • University of Michigan
        • Contact:
      • Big Rapids, Michigan, United States, 49307
        • Recruiting
        • Michigan College of Optometry at Ferris State Univ
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Pediatric Ophthalmology, P.C.
        • Contact:
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Children's Eye Care PC
        • Contact:
    • Minnesota
      • Duluth, Minnesota, United States, 55811
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:
        • Contact:
          • Raymond G Areaux, M.D
          • Phone Number: 612) 625-4120
          • Email: areaux@umn.edu
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Department of Ophthalmology
        • Contact:
      • Sartell, Minnesota, United States, 56377
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Samiksha Fouzdar Jain, MD
          • Phone Number: (402)559-2977
    • New York
      • Buffalo, New York, United States, 14209
        • Recruiting
        • Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
        • Contact:
      • New York, New York, United States, 10017
      • New York, New York, United States, 10036
        • Recruiting
        • State University of New York, College of Optometry
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Durham, North Carolina, United States, 27710
    • North Dakota
      • Grand Forks, North Dakota, United States, 58202
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cole Eye Institute
        • Contact:
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Pediatric Ophthalmology Associates, Inc.
        • Contact:
      • Columbus, Ohio, United States, 43210-1280
        • Recruiting
        • Ohio State University College of Optometry
        • Principal Investigator:
          • Marjean T Kulp, O.D.
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Rainbow Babies and Children's Hospital Dept of Ophth
        • Contact:
      • Poland, Ohio, United States, 44514
        • Recruiting
        • Eye Care Associates, Inc.
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Casey Eye Institute
        • Contact:
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16501
        • Recruiting
        • Pediatric Ophthalmology of Erie
        • Contact:
      • Lancaster, Pennsylvania, United States, 17601
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Wills Eye Hospital
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Pennsylvania College of Optometry, Salus at Drexel University
        • Contact:
    • South Carolina
      • Columbia, South Carolina, United States, 29203
      • Mt. Pleasant, South Carolina, United States, 29464
        • Recruiting
        • Storm Eye Institute
        • Contact:
          • James Bowsher
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • Southern College of Optometry
        • Contact:
      • Nashville, Tennessee, United States, 37232-8808
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital - Dept. Of Ophthalmology
        • Contact:
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech University Health Science Center
        • Contact:
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • University of the Incarnate Word
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Pediatric Eye Center
        • Contact:
      • Norfolk, Virginia, United States, 23502-3942
        • Recruiting
        • Earl R. Crouch, III
        • Principal Investigator:
          • Earl R. Crouch, III, M.D.
        • Contact:
          • Earl R. Crouch, III, M.D.
          • Phone Number: (757) 461-0050
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital, University of Washington
        • Contact:
          • Vivian Manh, O.D., M.S.
          • Phone Number: 206-987-4950
          • Email: vmanh@uw.edu
        • Principal Investigator:
          • Vivian Manh, O.D., M.S>
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Spokane Eye Clinical Research
        • Contact:
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.

  1. Age 4 to 7 years.

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Luminopia
dichoptic movies/shows shown through a virtual reality headset
Active Comparator: 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.
Other: Eye Patch
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
Time Frame: 26 Weeks
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

National Eye Institute (NEI)
Pediatric Eye Disease Investigator Group

Investigators

  • Principal Investigator: Robert Henderson, MS, Jaeb Center for Health Research
  • Study Chair: Aparna Raghuram, OD, PhD, Boston Children's Hospital/ Harvard Medical School
  • Study Chair: Kammi Gunton, MD, Wills Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATS23
  • 2UG1EY011751 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available after publication.

IPD Sharing Access Criteria

Users accessing the data must enter an email address.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe