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RECRUITING

NCT04378790

PHASE3

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 13 Years

Study Type

INTERVENTIONAL

Enrollment

544

Start Date

2020-12-08

Completion Date

2028-05-01

Last Updated

2026-02-11

Healthy Volunteers

Conditions

Amblyopia

Interventions

OTHER

Patching

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

OTHER

Glasses

Eye Glasses are created and worn by patient to improve vision

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.

Locations (68)

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Midwestern University Eye Institute

Glendale, Arizona, United States

Arizonia Pediatric Eye Specialists

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Univ. of California- Berkeley

Berkeley, California, United States

Marshall B. Ketchum University

Fullerton, California, United States

Univ of California, Irvine- Gavin Herbert Eye Institute

Irvine, California, United States

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, United States

Children's Hospital of Los Angeles (CHLA)

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Western University College of Optometry

Pomona, California, United States

University of California, Davis

Sacramento, California, United States

University of California San Francisco Department of Ophthalmology

San Francisco, California, United States

Eye Physicians & Surgeons, PC

Milford, Connecticut, United States

Nova Southeastern University College of Optometry, The Eye Institute

Fort Lauderdale, Florida, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

University of South Florida (USF) Eye

Tampa, Florida, United States

St Luke's Hospital

Boise, Idaho, United States

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

Chicago, Illinois, United States

Ticho Eye Associates

Chicago Ridge, Illinois, United States

Midwestern U Chicago College of Optometry

Downers Grove, Illinois, United States

Progressive Eye Care

Lisle, Illinois, United States

Indiana School of Optometry

Bloomington, Indiana, United States

Indiana University School of Optometry

Indianapolis, Indiana, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Wilmer Eye Institute

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Boston Children's Hospital Waltham

Boston, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan, United States

Zenith Vision Development Center

Duluth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

PineCone Vision Center

Sartell, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

St. Louis Children's Hospital Eye Center

St Louis, Missouri, United States

U of MO St. Louis College of Optometry

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

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

Buffalo, New York, United States

NYU Langone Health

New York, New York, United States

State University of New York, College of Optometry

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University Eye Center

Durham, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Ohio State University College of Optometry

Columbus, Ohio, United States

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, United States

River View Family Eyecare

Albany, Oregon, United States

Casey Eye Institute

Portland, Oregon, United States

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, United States

Conestoga Eye

Lancaster, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Salus University/Pennsylvania College of Optometry

Philadelphia, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

Prisma Health

Columbia, South Carolina, United States

Southern College of Optometry

Memphis, Tennessee, United States

Vanderbilt University Medical Center - Vanderbilt Eye Institute

Nashville, Tennessee, United States

Pediatric Eye Specialists, LLP

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Texas Tech University Health Science Center

Lubbock, Texas, United States

University of the Incarnate Word

San Antonio, Texas, United States

San Antonio Eye Center

San Antonio, Texas, United States

University of Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, United States

Rocky Mountain Eye Care Associates

Salt Lake City, Utah, United States

Virginia Pediatric Eye Center

Norfolk, Virginia, United States

Seattle Children's Hospital, University of Washington

Seattle, Washington, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

Snowy Range Vision Center

Laramie, Wyoming, United States

Clinical Research Directory

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)