Recruiting
Phase 3

Sequential vs Simultaneous

Sponsor:

Jaeb Center for Health Research

Code:

NCT04378790

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 3 - 13

Healthy Volunteers: Not accepted

Interventions

Patching

Glasses

Study Details

Brief 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.

Conditions

Amblyopia

Study ID

NCT04378790

Start date

Dec 8, 2020

Status verified date

Feb, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 13

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 3 to <13 years at the time of randomization
2. 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:

  • 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
3. No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
4. 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:

1. Full correction of anisometropia
2. Full correction of astigmatism with the same axis found by the cycloplegic refraction
3. Full correction of any myopia
4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
5. 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).
6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
7. Parent understands the protocol and is willing to accept randomization.
8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.

Exclusion Criteria:

1. Myopia greater than -6.00 D spherical equivalent in either eye.
2. Previous intraocular or refractive surgery.
3. Planned strabismus surgery in the next 56 weeks.
4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
5. Previous spectacle or contact lens wear for more than 24 hours.
6. Parent and participant willing to forego option of contact lens wear for the duration of the study.
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 VA criteria are met).
8. 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.
9. Known allergy to adhesive patches.
10. Known allergy to silicone.

Study Design

Enrollment

544 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sequential treatment

full-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)

experimental: Simultaneous treatment

full-time spectacle correction and part-time patching for 2 hours per day/7 days per week

Interventions

Patching

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

Glasses

Eye Glasses are created and worn by patient to improve vision

Primary outcome measure

  • Mean Change in Amblyopic Eye logMAR distance Visual Acuity [ Time Frame: 56 weeks ]

Central Contacts and Locations

Central contacts

Raymond T Kraker, MSPH

813-975-8690rkraker@jaeb.org

Brooke P Fimbel

813-975-8690

Locations

UAB Pediatric Eye Care; Birmingham Health Care

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Kristine Hopkins, O.D.

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Katherine Weise, OD, MBA

205-934-6739kweise@uab.edu

Midwestern University Eye Institute

Recruiting

Glendale, Arizona, United States, 85308

Contacts

Alicia Feis, OD

623-806-7271afeis@midwestern.edu

Arizonia Pediatric Eye Specialists

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

James L Plotnik, MD

480-513-6920JPlotnik@phoenixchildrens.com

University of Arizona

Recruiting

Tucson, Arizona, United States, 85711

Contacts

Jonathan M Holmes, MD

(520) 321-3677jmholmes@arizona.edu

Univ. of California- Berkeley

Recruiting

Berkeley, California, United States, 94720

Contacts

Jennifer H Fisher, OD

510-642-2020jenhfisher@berkeley.edu

Marshall B. Ketchum University

Recruiting

Fullerton, California, United States, 92831

Contacts

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

714-449-7432angelachen@ketchum.edu

Principal Investigator:

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

Univ of California, Irvine- Gavin Herbert Eye Institute

Recruiting

Irvine, California, United States, 92697

Contacts

Donny Suh, MD, MBA

949-824-9089dowsuh@gmail.com

Loma Linda University Health Care, Dept. of Ophthalmology

Recruiting

Loma Linda, California, United States, 92354

Contacts

Timothy Winter, M.D.

909-558-2168twwinter@llu.edu

Children's Hospital of Los Angeles (CHLA)

Recruiting

Los Angeles, California, United States, 90027

Contacts

Melinda Chang, MD

mchang@chla.usc.edu

Stanford University

Recruiting

Palo Alto, California, United States, 94303

Contacts

Tawna L Roberts, OD

650-724-7115tawnar@stanford.edu

Western University College of Optometry

Recruiting

Pomona, California, United States, 91766

Contacts

Ida Chung, OD

909-469-8687ichung@westernu.edu

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Benjamin G Jastrzembski, MD

benjast@ucdavis.edu

University of California San Francisco Department of Ophthalmology

Recruiting

San Francisco, California, United States, 94143

Contacts

Alejandra de Alba Campomanes, MD

415-353-2560dealbaa@vision.ucsf.edu

Eye Physicians & Surgeons, PC

Recruiting

Milford, Connecticut, United States, 06460

Contacts

Jennifer A Galvin, MD

203-795-0766jennygalvin@gmail.com

Nova Southeastern University College of Optometry, The Eye Institute

Recruiting

Fort Lauderdale, Florida, United States, 33382

Contacts

Micheal Au, OD

954-262-1426michau@nova.edu

Nemours Children's Clinic

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

John Erickson, OD

904-697-3775john.erickson@nemours.org

University of South Florida (USF) Eye

Recruiting

Tampa, Florida, United States, 33620

Contacts

Syeda Basith

sysumara@gmail.com

St Luke's Hospital

Recruiting

Boise, Idaho, United States, 83702

Contacts

Kevin Gertsch, MD

gertschk@slhs.org

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Bahram Rahmani, MD

312-227-6189BRahmani@luriechildrens.org

Ticho Eye Associates

Recruiting

Chicago Ridge, Illinois, United States, 60415

Contacts

Benjamin Ticho

708-423-4070Bticho@mac.com

Midwestern U Chicago College of Optometry

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Samantha Rice, O.D

630-743-4500srice@midwestern.edu

Progressive Eye Care

Recruiting

Lisle, Illinois, United States, 60532

Contacts

Patricia Davis, M.D.

630-245-0989idocmd@comcast.net

Indiana School of Optometry

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Don W. Lyon, O.D.

317-856-1964dwlyon@Indiana.edu

Principal Investigator:

Don W. Lyon, O.D.

Indiana University School of Optometry

Recruiting

Indianapolis, Indiana, United States, 47405

Contacts

Kathryn M Haider, MD

317-944-8103khaider@iupui.edu

Principal Investigator:

Kathyrn M Haider, MD

Wolfe Eye Clinic

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Derek Bitner, MD

(800) 542-7957dbitner@wolfeclinic.com

Wilmer Eye Institute

Recruiting

Baltimore, Maryland, United States, 21287-9028

Contacts

Michael X Repka, MD

(410) 955-8314mrepka@jhmi.edu

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Stephen Christiansen, MD

617-414-2020spchris@bu.edu

Boston Children's Hospital Waltham

Recruiting

Boston, Massachusetts, United States, 02453

Contacts

Aparna Raghuram, O.D., Ph.D.

617-355-6401aparna.raghuram@childrens.harvard.edu

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Brooke Geddie, DO

616-267-2605brooke.geddie@helendevoschildrens.org

Pediatric Ophthalmology, P.C.

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Patrick Droste, MD

(616) 957-0866drdroste@comcast.net

Zenith Vision Development Center

Recruiting

Duluth, Minnesota, United States, 55811

Contacts

RaeAnn M Nordwall, OD

2182490685rnordwall@zenithvisiondevelopment.com

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Erick D Bothun

bothun.erick@mayo.edu

PineCone Vision Center

Recruiting

Sartell, Minnesota, United States, 56377

Contacts

Kevy M Simmons, OD

320-258-3915ksimmons@pineconevisioncenter.com

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Jennifer Qayum, MD

816-701-1337jvqayum@cmh.edu

St. Louis Children's Hospital Eye Center

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Margaret M Reynolds, MD

(314) 454-6026margaret.reynolds@wustl.edu

U of MO St. Louis College of Optometry

Recruiting

St Louis, Missouri, United States, 63121

Contacts

Erin Brooks

314-516-5808brooksem@umsl.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Samiksha Jain, MD

sjain@childrensomaha.org

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

Recruiting

Buffalo, New York, United States, 14209

Contacts

John H Lillvis, MD PhD

716-881-7900jhlillvi@buffalo.edu

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Zachary Elkin, MD

zachary.elkin@nyulangone.org

State University of New York, College of Optometry

Recruiting

New York, New York, United States, 10036

Contacts

Marilyn Vricella, OD

(212) 780-5182mvricella@sunyopt.edu

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Katherine O Whitfield, MD

919-966-5296katherine_whitfield@med.unc.edu

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Nathan L Cheung, OD

nathan.cheung@duke.edu

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Cassandra S Solis, O.D

330-543-5150csolis@akronchildrens.org

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Michael Gray, MD

513-636-4751Michael.Gray@cchmc.org

Ohio State University College of Optometry

Recruiting

Columbus, Ohio, United States, 43210-1280

Contacts

Marjean T Kulp, O.D.

(614) 688-3336mtkulp@optometry.ohio-state.edu

Principal Investigator:

Marjean T Kulp, O.D.

Dean A. McGee Eye Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Maria E Lim

maria-lim@dmei.org

River View Family Eyecare

Recruiting

Albany, Oregon, United States, 97321

Contacts

Aaron D Salzano, OD

541-967-3097aaron.salzano@gmail.com

Casey Eye Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Allison Summers, OD

503-494-7830summersa@ohsu.edu

Pediatric Ophthalmology of Erie

Recruiting

Erie, Pennsylvania, United States, 16501

Contacts

Nicholas A Sala, D.O.

(814) 454-6307nasala@kidseyeserie.com

Conestoga Eye

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

David Silbert, MD

717-541-9700davidsilbertmd@gmail.com

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Kammi B Gunton, MD

215-928-3914kbgunton@comcast.net

Salus University/Pennsylvania College of Optometry

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Erin Jenewein, OD

(215) 276-6000Ejenewein@salus.edu

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Ken Nischal, MD

412-692-5918nischalkk@upmc.edu

Prisma Health

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Katie Keck, MD

katie.keck@prismahealth.org

Amelia Bartholdi, RN

803-434-4328amelia.bartholdi2@prismahealth.org

Southern College of Optometry

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Marie Bodack, OD

(901) 722-3276mbodack@sco.edu

Vanderbilt University Medical Center - Vanderbilt Eye Institute

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Lori Ann Kehler, OD

615-936-2020lori.kehler@vanderbilt.edu

Pediatric Eye Specialists, LLP

Recruiting

Fort Worth, Texas, United States, 76014

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Irene T Tung, MD

832-822-3230

Texas Tech University Health Science Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Lingkun Kong

832-283-1577lxxkong@gmail.com

University of the Incarnate Word

Recruiting

San Antonio, Texas, United States, 78209

Contacts

Raelyn Ottenbreit, OD

ottenbre@uiwtx.edu

San Antonio Eye Center

Recruiting

San Antonio, Texas, United States, 78215

Contacts

manpreet Chhabra

210-226-6169manpreetch@gmail.com

University of Incarnate Word Rosenberg School of Optometry

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Aubrey D Breithaupt, OD

210-283-6881breithau@uiwtx.edu

Rocky Mountain Eye Care Associates

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

David Petersen, MD

801-264-4450DPetersen@RMEyecare.com

Principal Investigator:

David Petersen, MD

Virginia Pediatric Eye Center

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Eric Crouch, MD

757-461-0050ercrouch@gmail.com

Seattle Children's Hospital, University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

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

206-987-4950vmanh@uw.edu

Principal Investigator:

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

Spokane Eye Clinical Research

Recruiting

Spokane, Washington, United States, 99204

Contacts

Jeffrey Colburn

509-456-0107jcolburn@spokaneeye.com

Snowy Range Vision Center

Recruiting

Laramie, Wyoming, United States, 82070

Contacts

Amy Aldrich

307-742-2020aldrich@snowyrangevision.com

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • patching
  • glasses
  • spectacles
  • simultaneous
  • sequential

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-02-11.