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AmblyopiaPhase 3ATS24NCT06524882

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

A Phase 3 study testing Vivid Vision, Luminopia and Optical Correction in people with Amblyopia, run by Jaeb Center for Health Research at 58 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Amblyopia
What is being tested?
Vivid Vision, Luminopia and Optical Correction
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
58 sitesUnited States
Study dates
22 Oct 2024to 1 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).
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  • 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.
  • No more than 2 weeks (cumulative) of prior dichoptic treatment
  • No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
  • 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).
  • 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.
  • 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.
  • Participant is willing to wear a headset.
  • Participant is willing to continue full-time spectacles/contact lens wear (if needed).
  • Interpupillary distance of 52mm to 72mm inclusive.
  • Investigator is willing to prescribe continued spectacles/contact lens correction (if needed) or either dichoptic device per protocol.
  • 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.
  • Parent understands the protocol and is willing to accept randomization.
  • Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff.
  • Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

58 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Raymond T Kraker, MSPH contact

813-975-8690

rkraker@jaeb.org

Brooke P Fimbel contact

813-975-8690

bfimbel@jaeb.org

58 sites in 1 country

United States58 sites, 58 recruiting

  • River View Family Eyecare

    Albany, Oregon, 97321

    Aaron D Salzano, OD, 541-967-3097, aaron.salzano@gmail.com

    Recruiting

  • University Eye Center at Ketchum Health

    Anaheim, California, 92807

    Susan Cotter, OD, MS, (714) 449-7488, scotter@ketchum.edu

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204-5809

    Allison A Jensen, MD, 443-849-6341, ajensen@gbmc.org

    Recruiting

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287-9028

    Michael X Repka, MD, (410) 955-8314, mrepka@jhmi.edu

    Recruiting

  • Univ. of California- Berkeley

    Berkeley, California, 94720

    Jennifer H Fisher, OD, 510-642-2020, jenhfisher@berkeley.edu

    Recruiting

  • Michigan College of Optometry at Ferris State Univ

    Big Rapids, Michigan, 49307

    Paula McDowell, 231-591-2182, PaulaMcDowell@ferris.edu

    Recruiting

  • UAB Pediatric Eye Care; Birmingham Health Care

    Birmingham, Alabama, 35294

    Kristine Hopkins, O.D.

    Recruiting

  • Indiana School of Optometry

    Bloomington, Indiana, 47405

    Katie W. Connolly, O.D., 812-856-0976, ksconnol@iu.edu

    Recruiting

  • New England College of Optometry

    Boston, Massachusetts, 02115

    Kristen L Kerber, OD, 6175875790, kerberk@neco.edu

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Stephen Christiansen, MD, 617-414-2020, spchris@bu.edu

    Recruiting

  • Boston Children's Hospital Waltham

    Boston, Massachusetts, 02453

    Aparna Raghuram, O.D., Ph.D., 617-355-6401, aparna.raghuram@childrens.harvard.edu

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Katherine O Whitfield, MD, 919-966-5296, katherine_whitfield@med.unc.edu

    Recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Sudhi Kurup, MD, 312-227-6189, SKurup@luriechildrens.org

    Hawke H Yoon, MD

    Recruiting

  • Illinois College of Optometry

    Chicago, Illinois, 60616

    Yi Pang, OD, PhD, 312-949-7287, ypang@ico.edu

    Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

    Michael Gray, MD, michael.gray@cchmc.org

    Recruiting

  • Cole Eye Institute

    Cleveland, Ohio, 44195

    Fatema F Ghasia, MD, 2164444363, ghasiaf@ccf.org

    Recruiting

  • Ohio State University College of Optometry

    Columbus, Ohio, 43210-1280

    Marjean T Kulp, O.D., (614) 688-3336, mtkulp@optometry.ohio-state.edu

    Marjean T Kulp, O.D.

    Recruiting

  • Midwestern University Eye Institute

    Downers Grove, Illinois, 60515

    Clinton R Prestwich, OD, 630-743-4801, cprest@midwestern.edu

    Recruiting

  • Zenith Vision Development Center

    Duluth, Minnesota, 55811

    RaeAnn M Nordwall, OD, 2182490685, rnordwall@zenithvisiondevelopment.com

    Recruiting

  • Duke University Eye Center

    Durham, North Carolina, 27710

    Nathan L Cheung, OD, nathan.cheung@duke.edu

    Recruiting

  • Pediatric Ophthalmology of Erie

    Erie, Pennsylvania, 16501

    Nicholas A Sala, D.O., (814) 454-6307, nasala@kidseyeserie.com

    Recruiting

  • Nova Southeastern University College of Optometry, The Eye Institute

    Fort Lauderdale, Florida, 33382

    Micheal Au, OD, 954-262-1426, michau@nova.edu

    Recruiting

  • Midwestern University Eye Institute

    Glendale, Arizona, 85308

    Alicia Feis, OD, 623-806-7271, afeis@midwestern.edu

    Christina A Esposito, OD

    Recruiting

  • University of North Dakota

    Grand Forks, North Dakota, 58202

    David H Biberdorf, davidbiberdorf@gmail.com

    Recruiting

  • Pediatric Ophthalmology, P.C.

    Grand Rapids, Michigan, 49546

    Patrick Droste, MD, (616) 957-0866, drdroste@comcast.net

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Adam J Cantor, MD, 8328223230, ajcantor@texaschildrens.org

    Amit R Bhatt, MD, 8328223230, arbhatt@texaschildrens.org

    Recruiting

  • University of Houston - College of Optometry

    Houston, Texas, 77204

    Maureen Plaumann, 713-743-2005, mdplaumann@uh.edu

    Recruiting

  • University of Houston College of Optometry

    Houston, Texas, 77204

    Ruth Manny, OD, PhD, 713-743-1944, rmanny@central.uh.edu

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Sara J Downes, sara-downes@uiowa.edu

    Recruiting

  • Univ of California, Irvine- Gavin Herbert Eye Institute

    Irvine, California, 92697

    Donny Suh, MD, MBA, 949-824-9089, dowsuh@gmail.com

    Recruiting

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

    Jennifer Qayum, MD, 816-701-1337, jvqayum@cmh.edu

    Recruiting

  • Conestoga Eye

    Lancaster, Pennsylvania, 17601

    David Silbert, MD, 717-541-9700, davidsilbertmd@gmail.com

    Recruiting

  • Progressive Eye Care

    Lisle, Illinois, 60532

    Patricia Davis, M.D., 630-245-0989, idocmd@comcast.net

    Recruiting

  • Arkansas Childrens

    Little Rock, Arkansas, 72202

    Adriana P Grigorian, M.D.

    Recruiting

  • McFarland Eye Care Center

    Little Rock, Arkansas, 72205

    Brita S Rook, MD, 5012254488, brook@mcfarlandeye.com

    Recruiting

  • Rainbow Babies and Children's Hospital Dept of Ophth

    Mayfield Heights, Ohio, 44124

    Adam J Peiffer, OD, 4406841743, adam.peiffer@uhhospitals.org

    Recruiting

  • Southern College of Optometry

    Memphis, Tennessee, 38104

    Marie Bodack, OD, (901) 722-3276, mbodack@sco.edu

    Recruiting

  • University of Minnesota-Minnesota Lions Children's Eye Clinic

    Minneapolis, Minnesota, 55454

    Raymond G Areaux, MD, 612-625-4120, areaux@umn.edu

    Recruiting

  • Storm Eye Institute

    Mt. Pleasant, South Carolina, 29464

    James Bowsher

    Recruiting

  • NYU Langone Health

    New York, New York, 10017

    Zachary Elkin, MD, zachary.elkin@nyulangone.org

    Recruiting

  • State University of New York, College of Optometry

    New York, New York, 10036

    Marilyn Vricella, OD, (212) 780-5182, mvricella@sunyopt.edu

    Recruiting

  • Virginia Pediatric Eye Center

    Norfolk, Virginia, 23502

    Eric Crouch, MD, 757-461-0050, ercrouch@gmail.com

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114

    Samiksha Fouzdar Jain, MD, (402)559-2977

    Recruiting

  • Stanford University

    Palo Alto, California, 94303

    Tawna L Roberts, OD, 650-724-7115, tawnar@stanford.edu

    Recruiting

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

    Kammi B Gunton, MD, 215-928-3914, kbgunton@comcast.net

    Recruiting

  • Salus University/Pennsylvania College of Optometry

    Philadelphia, Pennsylvania, 19141

    Erin Jenewein, OD, (215) 276-6000, Ejenewein@salus.edu

    Recruiting

  • Western University College of Optometry

    Pomona, California, 91766

    Ida Chung, OD, 909-469-8687, ichung@westernu.edu

    Recruiting

  • OHSU Casey Eye Institute

    Portland, Oregon, 97239

    Allison Summers, 503-494-7830, summersa@ohsu.edu

    Recruiting

  • University of Kansas Dept of Ophthalmology

    Prairie Village, Kansas, 66208

    Emily C Broxterman, MD, 913-588-6600, ebroxterman@kumc.edu

    Recruiting

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota, 55905

    Erick D Bothun, M.D., (507) 284-3760, Bothun.Erick@mayo.edu

    Recruiting

  • University of California, Davis

    Sacramento, California, 95817

    Benjamin G Jastrzembski, MD, benjast@ucdavis.edu

    Recruiting

  • San Antonio Eye Center

    San Antonio, Texas, 78215

    Lingkun Kong, MD, Ph.D, 2102266169 ext. 1005, lxxkong@gmail.com

    Recruiting

  • University of California San Francisco Department of Ophthalmology

    San Francisco, California, 94143

    Alejandra de Alba Campomanes, MD, 415-353-2560, dealbaa@vision.ucsf.edu

    Recruiting

  • PineCone Vision Center

    Sartell, Minnesota, 56377

    Kevy M Simmons, OD, 320-258-3915, ksimmons@pineconevisioncenter.com

    Recruiting

  • Phoenix Children's Medical Group - Ophthalmology

    Scottsdale, Arizona, 85255

    Jamila Hiasat, MD, 602-933-3937, jhiasat@phoenixchildrens.com

    Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

    Jeffrey Colburn, 509-456-0107, jcolburn@spokaneeye.com

    Recruiting

  • University of South Florida (USF) Eye

    Tampa, Florida, 33620

    Syeda Basith, sysumara@gmail.com

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85711

    Jonathan M Holmes, MD, (520) 321-3677, jmholmes@arizona.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Amblyopia
Being tested
Vivid Vision, Luminopia, Optical Correction
Keywords
Dichoptic, Luminopia, Vivid Vision, Game, movie, glasses
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivid VisionDevice

    dichoptic video games played through a virtual reality headset

  • LuminopiaDevice

    dichoptic movies/shows shown through a virtual reality headset

  • Optical CorrectionDevice

    Glasses prescribed at investigator discretion

Study groups in NCT06524882
Study groupRoleWhat they receive
Luminopia GroupExperimentaldichoptic 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
Receives: Device: Luminopia
Vivid Vision GroupExperimentaldichoptic 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
Receives: Device: Vivid Vision
Continued Optical Correction GroupActive comparatorcontinued full-time optical correction alone if needed
Receives: Device: Optical Correction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in amblyopic eye logMAR distance VA

    between randomization and 18 weeks

    Measured: 18 Weeks

Secondary outcomes (1)

  1. Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ).

    Questionnaire outcome

    Measured: 18 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start22 Oct 2024
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524882
Sponsor's protocol ID
ATS24
Other IDs
2UG1EY011751
Acronym
ATS24
Status last verified
Feb 2026
First submitted
23 Jul 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vivid Vision, Luminopia and Optical Correction in people with Amblyopia, run by Jaeb Center for Health Research at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raymond T Kraker, MSPH (813-975-8690, rkraker@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in amblyopic eye logMAR distance VA (time frame: 18 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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