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AmblyopiaPhase 3ATS22NCT04378790

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

A Phase 3 study testing Patching and Glasses in people with Amblyopia, run by Jaeb Center for Health Research at 68 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

A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age. Read more about this study

Who is it for?
Ages 3 to 13 years
Conditions the study is for
Amblyopia
What is being tested?
Patching and Glasses
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 participants
Where
68 sitesUnited States
Study dates
8 Dec 2020to 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 3 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 3 to <13 years at the time of randomization
  • Amblyopia associated with anisometropia, strabismus, or both
  • o 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 or without optical correction)
  • 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:
Show all 29Show fewer
  • 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 amblyopia: Both of the following criteria must be met:
  • Criteria for strabismus are 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
  • No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
  • Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:
  • Full correction of anisometropia
  • Full correction of astigmatism with the same axis found by the cycloplegic refraction
  • Full correction of any myopia
  • Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
  • At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows:
  • VA in the amblyopic eye 20/40 to 20/200 inclusive.
  • Age-normal VA in the fellow eye:40,41
  • 3 years: 0.4 logMAR (20/50) or better
  • 4 years: 0.3 logMAR (20/40) or better
  • 5-6 years: 0.2 logMAR (20/32) or better
  • 7-12 years: 0.12 logMAR (78 letters) or better
  • Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).
  • Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
  • 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 or other study staff.
  • Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.

Who cannot join

  • Myopia greater than -6.00 D spherical equivalent in either eye.
  • Previous intraocular or refractive surgery.
  • Planned strabismus surgery in the next 56 weeks.
  • Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
  • Previous spectacle or contact lens wear for more than 24 hours.
  • Parent and participant willing to forego option of contact lens wear for the duration of the study.
Show all 10Show fewer
  • 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 VA criteria are met).
  • 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 or attention deficit hyperactivity disorder (ADHD) are not excluded.
  • Known allergy to adhesive patches.
  • Known allergy to silicone.

Trial locations and contacts

68 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

68 sites in 1 country

United States68 sites, 68 recruiting

  • Akron Children's Hospital

    Akron, Ohio, 44308

    Cassandra S Solis, O.D, 330-543-5150, csolis@akronchildrens.org

    Recruiting

  • River View Family Eyecare

    Albany, Oregon, 97321

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

    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

  • UAB Pediatric Eye Care; Birmingham Health Care

    Birmingham, Alabama, 35294

    Kristine Hopkins, O.D.

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Katherine Weise, OD, MBA, 205-934-6739, kweise@uab.edu

    Recruiting

  • Indiana School of Optometry

    Bloomington, Indiana, 47405

    Don W. Lyon, O.D., 317-856-1964, dwlyon@Indiana.edu

    Don W. Lyon, O.D.

    Recruiting

  • St Luke's Hospital

    Boise, Idaho, 83702

    Kevin Gertsch, MD, gertschk@slhs.org

    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

  • 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

    Bahram Rahmani, MD, 312-227-6189, BRahmani@luriechildrens.org

    Recruiting

  • Ticho Eye Associates

    Chicago Ridge, Illinois, 60415

    Benjamin Ticho, 708-423-4070, Bticho@mac.com

    Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

    Michael Gray, MD, 513-636-4751, Michael.Gray@cchmc.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

  • 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 U Chicago College of Optometry

    Downers Grove, Illinois, 60515

    Samantha Rice, O.D, 630-743-4500, srice@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

  • Pediatric Eye Specialists, LLP

    Fort Worth, Texas, 76014

    Michael G Hunt, MD

    Recruiting

  • Marshall B. Ketchum University

    Fullerton, California, 92831

    Angela Chen, O.D., M.S., 714-449-7432, angelachen@ketchum.edu

    Angela Chen, O.D., M.S.

    Recruiting

  • Midwestern University Eye Institute

    Glendale, Arizona, 85308

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

    Christina A Esposito, OD

    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

  • Baylor College of Medicine

    Houston, Texas, 77030

    Irene T Tung, MD, 832-822-3230

    Recruiting

  • Indiana University School of Optometry

    Indianapolis, Indiana, 47405

    Kathryn M Haider, MD, 317-944-8103, khaider@iupui.edu

    Kathyrn M Haider, MD

    Recruiting

  • Univ of California, Irvine- Gavin Herbert Eye Institute

    Irvine, California, 92697

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

    Recruiting

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

    John Erickson, OD, 904-697-3775, john.erickson@nemours.org

    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

  • Snowy Range Vision Center

    Laramie, Wyoming, 82070

    Amy Aldrich, 307-742-2020, aldrich@snowyrangevision.com

    Recruiting

  • Progressive Eye Care

    Lisle, Illinois, 60532

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

    Recruiting

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California, 92354

    Timothy Winter, M.D., 909-558-2168, twwinter@llu.edu

    Recruiting

  • Children's Hospital of Los Angeles (CHLA)

    Los Angeles, California, 90027

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

    Recruiting

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79430

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

    Recruiting

  • Southern College of Optometry

    Memphis, Tennessee, 38104

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

    Recruiting

  • Eye Physicians & Surgeons, PC

    Milford, Connecticut, 06460

    Jennifer A Galvin, MD, 203-795-0766, jennygalvin@gmail.com

    Recruiting

  • Vanderbilt University Medical Center - Vanderbilt Eye Institute

    Nashville, Tennessee, 37232

    Lori Ann Kehler, OD, 615-936-2020, lori.kehler@vanderbilt.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

  • Virginia Pediatric Eye Center

    Norfolk, Virginia, 23502

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

    Recruiting

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

    Maria E Lim, maria-lim@dmei.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114

    Samiksha Jain, MD, sjain@childrensomaha.org

    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

  • Arizonia Pediatric Eye Specialists

    Phoenix, Arizona, 85006

    James L Plotnik, MD, 480-513-6920, JPlotnik@phoenixchildrens.com

    Recruiting

  • UPMC Children's Eye Center of Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Ken Nischal, MD, 412-692-5918, nischalkk@upmc.edu

    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

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Erick D Bothun, bothun.erick@mayo.edu

    Recruiting

  • University of California, Davis

    Sacramento, California, 95817

    Benjamin G Jastrzembski, MD, benjast@ucdavis.edu

    Recruiting

  • Rocky Mountain Eye Care Associates

    Salt Lake City, Utah, 84107

    David Petersen, MD, 801-264-4450, DPetersen@RMEyecare.com

    David Petersen, MD

    Recruiting

  • University of the Incarnate Word

    San Antonio, Texas, 78209

    Raelyn Ottenbreit, OD, ottenbre@uiwtx.edu

    Recruiting

  • San Antonio Eye Center

    San Antonio, Texas, 78215

    manpreet Chhabra, 210-226-6169 ext. 1005, manpreetch@gmail.com

    Recruiting

  • University of Incarnate Word Rosenberg School of Optometry

    San Antonio, Texas, 78229

    Aubrey D Breithaupt, OD, 210-283-6881, breithau@uiwtx.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

  • 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

  • St. Louis Children's Hospital Eye Center

    St Louis, Missouri, 63110

    Margaret M Reynolds, MD, (314) 454-6026, margaret.reynolds@wustl.edu

    Recruiting

  • U of MO St. Louis College of Optometry

    St Louis, Missouri, 63121

    Erin Brooks, 314-516-5808, brooksem@umsl.edu

    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

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

    Derek Bitner, MD, (800) 542-7957, dbitner@wolfeclinic.com

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to <13 Years Old

A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age.

Read the detailed description

At an enrollment visit, distance VA will be measured in trial frames with or without cycloplegia based on a cycloplegic refraction performed within 30 days. If still apparently eligible, children will be prescribed spectacles and will then return for a spectacle baseline visit, where they will wear their new spectacles for the first time for at least 10 minutes (but no more than 24 hours) and will be tested in those new spectacles to confirm final eligibility prior to randomization.

Participants not found to be eligible in their new spectacles will end study participation. Participants eligible for the study will be randomly allocated to one of two treatment groups: Sequential (spectacles alone) and then patching if needed (monitored by ODM), or Simultaneous (spectacles and patching monitored by ODM).

After randomization, follow-up visits will occur at 8-week intervals through 56 weeks. At each visit on or after the 8-week visit, participants will be classified as either: stable/worsening or improving; those stable/worsening are then classified as having either resolved or residual amblyopia, provided that the current and most recent previous visit were completed at least 6-weeks apart (target 8 weeks) and provided the required test and retest VA testing was completed. Participants who are stable/worsening and have residual amblyopia in the sequential group will start patching (monitored by ODM) and continue to be followed every 8 weeks. Participants in the simultaneous group, or in the sequential group after having advanced to patching, who are stable/worsening but have residual amblyopia will be released to treatment at investigator discretion.

All participants continue 8-weekly visits until 56 weeks when Study participation ends.

Conditions
Amblyopia
Being tested
Patching, Glasses
Keywords
patching, glasses, spectacles, simultaneous, sequential
Medical subject headings
Amblyopia

What participants receive

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

  • PatchingOther

    Also called Eye Patch

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

  • GlassesOther

    Also called Spectacles

    Eye Glasses are created and worn by patient to improve vision

Study groups in NCT04378790
Study groupRoleWhat they receive
Sequential treatmentActive comparatorfull-time spectacle correction first, with subsequent patching for 2 hours per day/7 days per week only if needed (no improvement (stable/worsening) and residual)
Receives: Other: Patching; Other: Glasses
Simultaneous treatmentExperimentalfull-time spectacle correction and part-time patching for 2 hours per day/7 days per week
Receives: Other: Patching; Other: Glasses

What is being measured

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

  1. Mean Change in Amblyopic Eye logMAR distance Visual Acuity

    1. Amblyopic eye VA (calculated as mean of test and retest) at the last visit that was the basis for a "stable resolved" or "stable residual" determination (in the sequential group, stable residual amblyopia criteria can be reached only after patching has been instituted); or
    2. 56-week visit amblyopic-eye VA (calculated as mean of test and retest) in those completing a 56-week visit without ever meeting criteria for "stable resolved" or "stable residual" amblyopia (if retest missing at 56 weeks, the single test value will be used).

    Measured: 56 weeks

Secondary outcomes (7)

  1. Pediatric Eye Questionnaire (PedEyeQ)

    Rasch scores for each questionnaire item will be obtained from published look-up tables available at www.pedig.net, and used to calculate a score for each participant and a separate treatment group mean for the three PedEyeQ domains of the Child, Proxy and Parent PedEyeQ at randomization and at each visit. Scores will also be converted to a 0-100 scale to aid in interpretation. Multiplicity adjusted two sided P-values and confidence intervals will be produced.

    Child PedEyeQ: Functional Vision, Bothered by Eyes and Vision, Social, Frustration / Worry Proxy PedEyeQ: Functional Vision, Bothered by Eyes and Vision, Social, Frustration / Worry, Eyecare Parent PedEyeQ: Impact on Parent and Family, Worry about Child's Eye Condition, Worry about Self-perception and Interactions, Worry about Functional Vision

    Measured: 56 weeks

  2. Proportion Achieving Stable Resolved Outcome with Spectacles Alone

    The proportion of participants in the Sequential Spectacles group who achieve "stable resolved" outcome status with spectacles alone will be calculated, along with a multiplicity adjusted two sided P-value and confidence interval.

    Measured: 56 Weeks

  3. Proportion of participants who achieve Binary distance visual acuity outcomes

    The proportion of participants who achieve the following binary outcomes will be tabulated by treatment group to aid in the interpretation of the primary outcome:

    • The proportion of participants with outcome amblyopic-eye distance VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) from baseline.
    • The proportion of participants with stable resolved VA.

    Poisson regression with the log link will be used to estimate the relative risk of each outcome for the sequential versus simultaneous and a multiplicity adjusted two sided P-value and confidence interval. The Poisson models will include an adjustment for baseline amblyopic eye VA.

    In the event the number of outcomes is too small for reliable estimation with Poisson regression,43 a treatment group difference and 95% confidence interval will be estimated using the Farrington-Manning Score test or other exact method with no adjustment for baseline VA.

    Measured: 56 weeks

  4. Time to Stable Resolved Amblyopia

    For those participants who are classified as "stable resolved," the time from baseline to the time meeting that classification will be compared between treatment groups, using a Kaplan-Meier analysis with the logrank test. Multiplicity adjusted two sided P-values and confidence intervals will be produced.

    Measured: 56 weeks

  5. Difference in Mean Change of Distance Visual Acuity after 8 Weeks on Randomized Treatment

    An analysis of covariance (ANCOVA) will be performed to compute the difference in mean change in amblyopic-eye distance logMAR VA after 8 weeks between the sequential and simultaneous treatment groups, adjusted for baseline amblyopic eye distance VA, and a multiplicity adjusted two sided P-value and confidence interval will be constructed on the treatment group difference for each time point.

    Measured: 56 Weeks

  6. Change in binocularity levels

    Binocularity will be assessed on an ordered scale combining the results of the Randot Preschool Test, Randot butterfly, and Worth 4-Dot (W4D) at near. Results of each individual test also will be tabulated at baseline and at the final study visit according to treatment group.

    The possible levels of binocularity will be 40, 60, 100, 200, 400, 800 seconds of arc (Randot Preschool test), 2000 seconds of arc (Randot butterfly), binocular perception by W4D (4 or 5 lights), or no binocular perception by W4D (2 or 3 lights). This yields an ordered binocularity scale with 9 ordered levels. The change in binocularity levels for each test will be tabulated and compared between treatment groups using the exact Wilcoxon rank-sum test. The proportion of participants in each treatment group unable to perform testing will be tabulated but these participants will not be included in the analysis of change.

    Measured: 56 Weeks

  7. Difference in mean change in amblyopic-eye log contrast sensitivity

    Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units). An analysis of covariance (ANCOVA) will be performed to compute the difference in mean change in amblyopic-eye log contrast sensitivity units between the sequential and simultaneous treatment groups, adjusted for baseline amblyopic eye contrast sensitivity, and a multiplicity adjusted two sided P-value and confidence interval will be produced.

    Measured: 56 weeks

Timeline

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

  1. First posted7 May 2020
  2. Study start8 Dec 2020
  3. Primary completion1 May 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
544 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378790
Sponsor's protocol ID
ATS22
Other IDs
2UG1EY011751
Acronym
ATS22
Status last verified
Feb 2026
First submitted
5 May 2020
Last updated
11 Feb 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 Patching and Glasses in people with Amblyopia, run by Jaeb Center for Health Research at 68 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 29 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 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?

Mean Change in Amblyopic Eye logMAR distance Visual Acuity (time frame: 56 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 NCT04378790.

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 11 Feb 2026.

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