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AmblyopiaPhase 3ATS23NCT06380517

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

A Phase 3 study testing Luminopia and Eye Patch in people with Amblyopia, run by Jaeb Center for Health Research at 73 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

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… Read more about this study

Who is it for?
Ages 4 to 7 years
Conditions the study is for
Amblyopia
What is being tested?
Luminopia and Eye Patch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
73 sitesUnited States
Study dates
11 Jul 2024to 1 Aug 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 4 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

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:
  3. VA in the amblyopic eye 20/40 to 20/200 inclusive.
  4. 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
  1. Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
  2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
  3. 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).
  1. 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.
  1. 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.
  1. No more than 2 weeks (cumulative) of prior dichoptic treatment.
  2. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
  3. 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.
  1. 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.
  1. Participant is willing to wear the Luminopia headset.
  2. Participant is willing to continue full-time spectacles/contact lens wear (if needed).
  3. 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.
  4. Interpupillary distance of 52mm to 72mm inclusive.
  5. Investigator is willing to prescribe Luminopia or patching per protocol.
  6. Parent understands the protocol and is willing to accept randomization.
  7. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.
  8. 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.

Trial locations and contacts

73 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

bfimmel@jaeb.org

73 sites in 1 country

United States73 sites, 73 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48105

    Jacqueline D Nguyen, OD, 734-764-4163, jackien@med.umich.edu

    Recruiting

  • The Emory Eye Center

    Atlanta, Georgia, 30322

    Carolina Adams, MD, (404) 778-4725, carolina.adams@emory.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

  • Specialized Pediatric Eye Care

    Beverly, Massachusetts, 01915

    Danielle M Ledoux, MD, dledoux@specializedpediatriceyecare.com

    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

    Jenna Titelbaum, OD, 617-414-2020

    Recruiting

  • Boston Children's Hospital Waltham

    Boston, Massachusetts, 02453

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

    Recruiting

  • Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology

    Buffalo, New York, 14209

    John H Lillvis, MD PhD, 716-881-7900, jhlillvi@buffalo.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, 513-636-4751, Michael.Gray@cchmc.org

    Recruiting

  • Cole Eye Institute

    Cleveland, Ohio, 44195

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

    Recruiting

  • Prisma Health

    Columbia, South Carolina, 29203

    Katie Keck, MD, katie.keck@prismahealth.org

    Amelia Bartholdi, RN, 803-434-4328, amelia.bartholdi2@prismahealth.org

    Recruiting

  • Pediatric Ophthalmology Associates, Inc.

    Columbus, Ohio, 43205

    Catherine O Jordan, MD, (614) 224-6222, cateolsonjordan@gmail.com

    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

  • Southern California College of Optometry

    Fullerton, California, 92831-1699

    Susan A. Cotter, O.D., 714-449-7488, scotter@scco.edu

    Kristine Huang, O.D., 714-449-7435, khuang@scco.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

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Brooke Geddie, DO, 616-267-2605, brooke.geddie@helendevoschildrens.org

    Recruiting

  • Pediatric Ophthalmology, P.C.

    Grand Rapids, Michigan, 49546

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

    Recruiting

  • Texas Children's Hospital - Dept. Of Ophthalmology

    Houston, Texas, 77030

    Amit Bhatt, MD, (832) 822-3230, arbhatt@texaschildrens.org

    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

    Justin Marsh, MD, 816-701-1337, jdmarsh@cmh.edu

    Recruiting

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

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

    Recruiting

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

    David L Nash, M.D., 608-775-0238, DLnash1@gundersenhealth.org

    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

  • Children's Hospital of Los Angeles (CHLA)

    Los Angeles, California, 90027

    Melinda Chang, MD, mchang@chla.usc.edu

    Recruiting

  • Jules Stein Eye Institute at the University of California, Los Angeles

    Los Angeles, California, 90095

    Stacy L Pineles, MD, 310-825-2872, pineles@jsei.ucla.edu

    Recruiting

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79430

    Lingkun Kong, 832-283-1577, lxxkong@gmail.com

    Recruiting

  • Rainbow Babies and Children's Hospital Dept of Ophth

    Mayfield Heights, Ohio, 44124

    Maryo C Kohen, MD, 4406841743, maryo.kohen@uhhospitals.org

    Recruiting

  • Southern College of Optometry

    Memphis, Tennessee, 38104

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

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55454

    Raymond G Areaux, M.D, 612) 625-4120, areaux@umn.edu

    Sasha Strul, M.D, sstrul@umn.edu

    Recruiting

  • Storm Eye Institute

    Mt. Pleasant, South Carolina, 29464

    James Bowsher

    Recruiting

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232-8808

    Sean P. Donahue, M.D., Ph.D., sean.donahue@vanderbilt.edu

    Recruiting

  • Yale University

    New Haven, Connecticut, 06511

    Martha Howard, 203.785.2020 ext. 2, martha.howard@yale.edu

    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

  • Earl R. Crouch, III

    Norfolk, Virginia, 23502-3942

    Earl R. Crouch, III, M.D., (757) 461-0050

    Earl R. Crouch, III, M.D.

    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

  • Pennsylvania College of Optometry, Salus at Drexel University

    Philadelphia, Pennsylvania, 19141

    Erin Jenewein, OD, (215) 276-6034, ej468@drexel.edu

    Recruiting

  • Eye Care Associates, Inc.

    Poland, Ohio, 44514

    S. Ayse Erzurum, M.D., 330-746-7691, erzurum2020@gmail.com

    Recruiting

  • Western University College of Optometry

    Pomona, California, 91766

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

    Recruiting

  • Casey Eye Institute

    Portland, Oregon, 97239

    Allison Summers, OD, 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

  • University of the Incarnate Word

    San Antonio, Texas, 78209

    Raelyn Ottenbreit, OD, ottenbre@uiwtx.edu

    Recruiting

  • Rady Children's Hospital - San Diego Dept of Ophthalmology

    San Diego, California, 92123

    Lauren M Hennein, MD, 858-309-7702 ext. 223669, lhennein@health.ucsd.edu

    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

  • Seattle Children's Hospital, University of Washington

    Seattle, Washington, 98105

    Vivian Manh, O.D., M.S., 206-987-4950, vmanh@uw.edu

    Vivian Manh, O.D., M.S>

    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

  • Children's Eye Care PC

    West Bloomfield, Michigan, 48322

    Lisa Bohra, MD, 248-254-8140, lisabohra@hotmail.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Amblyopia
Being tested
Luminopia, Eye Patch
Keywords
Dichoptic, Luminopia, Patching, movie
Medical subject headings
Amblyopia

What participants receive

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

  • LuminopiaDevice

    dichoptic movies/shows shown through a virtual reality headset

  • Eye PatchOther

    Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye

Study groups in NCT06380517
Study groupRoleWhat they receive
Luminopia GroupExperimentalwatching 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.
Receives: Device: Luminopia
Patching GroupActive comparatorpatching 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.
Receives: Other: Eye Patch

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 26 weeks

    Measured: 26 Weeks

Timeline

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

  1. First posted24 Apr 2024
  2. Study start11 Jul 2024
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Aug 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
238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06380517
Sponsor's protocol ID
ATS23
Other IDs
2UG1EY011751
Acronym
ATS23
Status last verified
Feb 2026
First submitted
18 Apr 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
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 Luminopia and Eye Patch in people with Amblyopia, run by Jaeb Center for Health Research at 73 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?

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 73 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 between randomization and 26 weeks (time frame: 26 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 NCT06380517.

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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