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NCT04378790PHASE3Recruiting

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Jaeb Center for Health Research

Start Date

12/8/2020

Completion Date

5/1/2028

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.

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.

Eligibility Criteria

Age Range: 3 years to 13 years

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.

Interventions

OTHER

Patching

OTHER

Glasses

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Conditions

Amblyopia

Locations

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama 35294

United States

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Midwestern University Eye Institute

Glendale, Arizona 85308

United States

Arizonia Pediatric Eye Specialists

Phoenix, Arizona 85006

United States

University of Arizona

Tucson, Arizona 85711

United States

Univ. of California- Berkeley

Berkeley, California 94720

United States

Marshall B. Ketchum University

Fullerton, California 92831

United States

Univ of California, Irvine- Gavin Herbert Eye Institute

Irvine, California 92697

United States

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California 92354

United States

Children's Hospital of Los Angeles (CHLA)

Los Angeles, California 90027

United States

Stanford University

Palo Alto, California 94303

United States

Western University College of Optometry

Pomona, California 91766

United States

University of California, Davis

Sacramento, California 95817

United States

University of California San Francisco Department of Ophthalmology

San Francisco, California 94143

United States

Eye Physicians & Surgeons, PC

Milford, Connecticut 06460

United States

Nova Southeastern University College of Optometry, The Eye Institute

Fort Lauderdale, Florida 33382

United States

Nemours Children's Clinic

Jacksonville, Florida 32207

United States

University of South Florida (USF) Eye

Tampa, Florida 33620

United States

St Luke's Hospital

Boise, Idaho 83702

United States

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

Chicago, Illinois 60611

United States

Ticho Eye Associates

Chicago Ridge, Illinois 60415

United States

Midwestern U Chicago College of Optometry

Downers Grove, Illinois 60515

United States

Progressive Eye Care

Lisle, Illinois 60532

United States

Indiana School of Optometry

Bloomington, Indiana 47405

United States

Indiana University School of Optometry

Indianapolis, Indiana 47405

United States

Wolfe Eye Clinic

West Des Moines, Iowa 50266

United States

Wilmer Eye Institute

Baltimore, Maryland 21287-9028

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Boston Children's Hospital Waltham

Boston, Massachusetts 02453

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan 49546

United States

Zenith Vision Development Center

Duluth, Minnesota 55811

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

PineCone Vision Center

Sartell, Minnesota 56377

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri 64108

United States

St. Louis Children's Hospital Eye Center

St Louis, Missouri 63110

United States

U of MO St. Louis College of Optometry

St Louis, Missouri 63121

United States

University of Nebraska Medical Center

Omaha, Nebraska 68114

United States

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

Buffalo, New York 14209

United States

NYU Langone Health

New York, New York 10017

United States

State University of New York, College of Optometry

New York, New York 10036

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Duke University Eye Center

Durham, North Carolina 27710

United States

Akron Children's Hospital

Akron, Ohio 44308

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Ohio State University College of Optometry

Columbus, Ohio 43210-1280

United States

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma 73104

United States

River View Family Eyecare

Albany, Oregon 97321

United States

Casey Eye Institute

Portland, Oregon 97239

United States

Pediatric Ophthalmology of Erie

Erie, Pennsylvania 16501

United States

Conestoga Eye

Lancaster, Pennsylvania 17601

United States

Wills Eye Hospital

Philadelphia, Pennsylvania 19107

United States

Salus University/Pennsylvania College of Optometry

Philadelphia, Pennsylvania 19141

United States

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

Pittsburgh, Pennsylvania 15224

United States

Prisma Health

Columbia, South Carolina 29203

United States

Southern College of Optometry

Memphis, Tennessee 38104

United States

Vanderbilt University Medical Center - Vanderbilt Eye Institute

Nashville, Tennessee 37232

United States

Pediatric Eye Specialists, LLP

Fort Worth, Texas 76014

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Texas Tech University Health Science Center

Lubbock, Texas 79430

United States

University of the Incarnate Word

San Antonio, Texas 78209

United States

San Antonio Eye Center

San Antonio, Texas 78215

United States

University of Incarnate Word Rosenberg School of Optometry

San Antonio, Texas 78229

United States

Rocky Mountain Eye Care Associates

Salt Lake City, Utah 84107

United States

Virginia Pediatric Eye Center

Norfolk, Virginia 23502

United States

Seattle Children's Hospital, University of Washington

Seattle, Washington 98105

United States

Spokane Eye Clinical Research

Spokane, Washington 99204

United States

Snowy Range Vision Center

Laramie, Wyoming 82070

United States