Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age (ATS24)

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

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

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

Study Contact Backup

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

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
      • Anaheim, California, United States, 92807
        • Recruiting
        • University Eye Center at Ketchum Health
        • Contact:
      • Berkeley, California, United States, 94720
        • Recruiting
        • Univ. of California- Berkeley
        • Contact:
      • Irvine, California, United States, 92697
        • Recruiting
        • Univ of California, Irvine- Gavin Herbert Eye Institute
        • 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 Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco Department of Ophthalmology
        • Contact:
    • Florida
      • Fort Lauderdale, Florida, United States, 33382
        • Recruiting
        • Nova Southeastern University College of Optometry, The Eye Institute
        • Contact:
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida (USF) Eye
        • 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
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Stephen Christiansen, MD
          • Phone Number: 617-414-2020
          • Email: spchris@bu.edu
      • Boston, Massachusetts, United States, 02453
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • New England College of Optometry
        • Contact:
    • Michigan
      • Big Rapids, Michigan, United States, 49307
        • Recruiting
        • Michigan College of Optometry at Ferris State Univ
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Pediatric Ophthalmology, P.C.
        • Contact:
    • Minnesota
      • Duluth, Minnesota, United States, 55811
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota-Minnesota Lions Children's Eye Clinic
        • Contact:
          • Raymond G Areaux, MD
          • 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
      • 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
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cole Eye Institute
        • 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:
    • Oregon
      • Albany, Oregon, United States, 97321
        • Recruiting
        • River View Family Eyecare
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU 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
        • Salus University/Pennsylvania College of Optometry
        • Contact:
    • South Carolina
      • 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:
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77204
        • Recruiting
        • University of Houston College of Optometry
        • Contact:
      • Houston, Texas, United States, 77204
        • Recruiting
        • University of Houston - College of Optometry
        • Contact:
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • San Antonio Eye Center
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Pediatric Eye Center
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Spokane Eye Clinical Research
        • Contact:

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

Inclusion Criteria:

  1. Age 8 to <13 years.

  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:

  1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
  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.

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
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
Device: Luminopia
dichoptic movies/shows shown through a virtual reality headset
Experimental: 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
Device: Vivid Vision
dichoptic video games played through a virtual reality headset
Active Comparator: Continued Optical Correction Group
continued full-time optical correction alone if needed
Device: Optical Correction
Glasses prescribed at investigator discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in amblyopic eye logMAR distance VA
Time Frame: 18 Weeks
between randomization and 18 weeks
18 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ).
Time Frame: 18 Weeks
Questionnaire outcome
18 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

  • Study Chair: Marjean T Kulp, OD, Ohio State University
  • Study Chair: Benajmin G Jastrzembski, MD, University of California, Davis

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)

October 22, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 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

  • ATS24
  • 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

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.

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