A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia

Purpose | Background | Description | Patient Eligibility | Recruitment Status | Current Status | Results | Publications | Clinical Centers | Resource Centers | NEI Representative

Purpose

• To determine whether the visual acuity improvement obtained with part-time (6 hours) patching is equivalent to the visual acuity improvement obtained with minimal patching (2 hours) for moderate amblyopia
• To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching
• To identify factors that may be associated with successful treatment of amblyopia with patching

Background

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally held that the response to treatment is best when it is instituted at an early age, particularly by age two or three, and is poor when attempted after eight years of age.


For moderate amblyopia, patching is the most commonly prescribed treatment although other modalities such as atropine penalization are also prescribed. There is no specific patching regimen that is widely accepted for treatment of moderate amblyopia and limited or no data available to favor the use of one specific regimen; both minimal occlusion (e.g., 2 hours per day) and six or more hours per day of patching are prescribed in clinical practice.

Description

The study is a randomized trial comparing daily patching regimes for children with moderate amblyopia. It will consist of about 160 children. Patients in the moderate (20/40-20/80) group will patch part-time (6 hours) or minimal time (2 hours) of each day for the 4-month study period. There are at least two follow up visits during the 4-month period. Visual acuity is the major study outcome. It is assessed at the 4-month exam.

Patient Eligibility

Patients must be less than 7 years of age with original cause of amblyopia due strabismus or anisometropia. Visual Acuity in the amblyopic eye must be between 20/40 and 20/80, visual acuity in the sound eye of 20/40 or better and there must be at least 3 lines of acuity difference between the two eyes. Patients must have had no patching treatment (other than spectacles) within six months prior to enrollment and no other amblyopia treatment of any type used within one month prior to enrollment.

Patient Recruitment Status

Completed. Recruitment began in May 2001 and closed in May 2002 after 189 patients were enrolled.

Current Status of Study

Completed.

Results

For moderate amblyopia, prescribing two hours of daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by prescribing six hours of daily patching in children 3 to less than 7 years of age.

Publications

The Pediatric Eye Disease Investigator Group: A randomized trial of patching regimens for treatment of moderate amblyopia in children. . Arch Ophthalmol 121: 603-611, 2003.

Clinical Centers

Alabama
Wendy L. Marsh-Tootle, O.D.
Robert P. Rutstein, O.D.
University of Alabama at Birmingham
School of Optometry
1716 University Boulevard
Birmingham, AL 35294

Alaska
Robert W. Arnold, M.D.
Ophthalmic Associates
542 Second Avenue
Anchorage, AK 99501-2242

Alberta
William F. Astle, M.D.
Anna L. Ellis, M.D.
Alberta Children's Hospital
1820 Richmond Road, SW
Calgary, AB T2T 5C7 Canada

California
Carmen Barnhardt, O.D.
Susan A. Cotter, O.D.
Raymond H. Chu, O.D.
John H. Lee, O.D.
Susan M. Shin, O.D.
Southern California College of Optometry
2575 Yorba Linda Boulevard
Fullerton, CA 92831

James B. Ruben, M.D.
The Permanente Medical Group
1650 Response Road
Sacramento, CA 95815

Connecticut
Darron A. Bacal, M.D.
Eye Physicians & Surgeons, PC
202 Cherry Street
Milford, CT 06460

Andrew J. Levada, M.D.
Ophthalmic Surgical Associates
1201 West Main Street, Suite 100
Waterbury, CT 06708

Andrew J. Levada, M.D.
The Eye Care Group, PC
1201 West Main Street, Suite 100
Waterbury, CT 06708

Florida
Susanna M. Tamkins, O.D.
NOVA Southeastern University
3200 S. University Drive
Ft. Lauderdale, FL 33328

Georgia
Scott R. Lambert, M.D.
The Emory Eye Center
Department of Ophthalmology
1365-B Clifton Road, N.E.
Atlanta, GA 30322

Illinois
Deborah R. Fishman, M.D.
Pediatric Eye Associates
3612 Lake Ave Unit 3
Wilmette, IL 60091-1000

Indiana
Daniel E. Neely, M.D.
David A. Plager, M.D.
Naval Sondhi, M.D.
Derek T. Sprunger, M.D.
Indiana University Medical Center
702 Rotary Circle
Indianapolis, IN 46202

Kansas
David A. Johnson, M.D.
The Grene Vision Group
655 North Woodlawn
Wichita, KS 67208

Maryland
Stephen R. Glaser, M.D.
15235 Shady Grove Road, Suite 101
Rockville, MD 20850

Michael X. Repka, M.D.
Wilmer Ophthalmological Institute
233 Wilmer Institute
600 N. Wolfe Street
Baltimore, MD 21287-9028

Mexico
Miguel Paciuc, M.D.
Paseo de las Palmas 735-1102
Lomas de Chapultepec, MX 11000 Mexico

Michigan
Patrick J. Droste, M.D.
Robert J. Peters, M.D.
Pediatric Ophthalmology, P.C
1000 East Paris SE #250
Grand Rapids, MI 49546

Minnesota
Susan Schloff, M.D.
Associated Eye Care
280 N. Smith Ave
St. Paul, MN 55102

Jonathan M. Holmes, M.D.
Mayo Clinic
200 First Street, SW
Rochester, MN 55905

Stephen P. Christiansen, M.D.
C. Gail Summers, M.D.
University of Minnesota
Department of Ophthalmology
Box 493
420 Delaware Street, SE
Minneapolis, MN 55455

Missouri
Oscar A. Cruz, M.D.
Bradley V. Davitt, M.D.
Cardinal Glennon Children's Hospital
1465 South Grand Boulevard
St. Louis, MO 63104

North Carolina
David K. Wallace, M.D.
University of North Carolina
Department of Ophthalmology
617 Burnett-Womack, CB #7040
Chapel Hill, NC 27599-7040

Ohio
Constance E. West, M.D.
Children's Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229

Richard W. Hertle, M.D.
Pediatric Ophthalmology Associates, Inc.
555 South 18th Street
Suite 4C
Columbus, NC 43025

Marjean T. Kulp, O.D.
The Ohio State University College of Optometry
P. O. Box 182342
Columbus, OH 43218

Pennsylvania
Brian J. Forbes, Ph.D.,M.D.
Monte D. Mills, M.D.
Children's Hospital of Philadelphia
Wood Center, 1st Floor
Philadelphia, PA 19104

David I. Silbert, M.D.
Family Eye Group
2110 Harrisburg Pike, Suite 215
Lancaster, PA 17604

Nicholas A. Sala, D.O.
Pediatric Ophthalmology of Erie
2201 W. 38th Street
Erie, PA 16506

Mitchell M. Scheiman, O.D.
Pennsylvania College Of Optometry
1200 West Godfrey Avenue
Philadelphia, PA 19141

Rhode Island
Glenn E. Bulan, M.D.
D. Robbins Tien, M.D.
Pediatric Ophthalmology and Strabismus Associates
2 Dudley Street, Suite 505
Providence, RI 02905

John P. Donahue, M.D.,Ph.D.
Rhode Island Eye Institute
150 East Manning Street
Providence, RI 02906

Texas
David R. Stager, Jr., M.D.
Pediatric Ophthalmology, P.A.
8201 Preston Road, Suite 140A
Dallas, TX 75225-6203

David K. Coats, M.D.
Evelyn A. Paysse, M.D.
Texas Children's Hospital
6621 Fannin, CCC-640.00
Houston, TX 77030

David R. Weakley, Jr., M.D.
University of Texas Southwestern Medical Center
5323 Harry Hines Boulevard
Dallas, TX 75235-9057

Virginia
Earl R. Crouch, Jr., M.D.
Eastern Virginia Medical School
Department of Ophthalmology
880 Kempsville Road, Suite 2500
Norfolk, VA 23502-3931

Wisconsin
Jane D. Kivlin, M.D.
Mark S. Ruttum, M.D.
Medical College of Wisconsin
925 N. 87th Street
Milwaukee, WI 53226-4812

Resource Centers

Co-Chairman's Office
Jonathan M. Holmes, M.D.
Mayo Clinic
Department of Ophthalmology W7
200 First Street Southwest
Rochester, MN 55905
Telephone: (507) 284-3760
Fax: (507) 284-8566
E-mail: holmes.jonathan@mayo.edu

Michael X. Repka, M.D.
Wilmer Eye Institute
233 Wilmer Institute
600 N. Wolfe Street
Baltimore, MD 21287-9028
Telephone: (410) 955-0809
Fax: (410) 955-8314
E-mail: mrepka@jhmi.edu

Data Coordination Center
Roy W. Beck, Ph.D.
Pamela S. Moke, M.S.P.H.
Raymond T. Kraker, M.S.P.H.
Heidi A. Gillespie
Alisha N. Lawson
Nicole M. Boyle
Julie A. Gillett
Shelly T. Mares
Brian B. Dale
Jaeb Center for Health Research
3010 E 138th Avenue
Suite 9
Tampa, FL 33613
Telephone: (813) 975-8690
Fax: (813) 975-8761
E-mail: pedig@jaeb.org
http://public.pedig.jaeb.org/

Data and Safety Monitoring Committee

William Barlow, Ph.D.
Group Health Cooperative
Seattle, WA

Edward G. Buckley, M.D.
Duke University Medical Center
Durham, NC

Barry Davis, M.D., Ph.D.
University of Texas
Houston, TX

Velma Dobson, Ph.D.
University of Arizona
Tucson, AZ

John L. Keltner, M.D
University of California
Sacramento, CA

Hana Osman, Ph.D.
Louis de la Parte Florida Mental Health Institute
Tampa, FL

Earl A. Palmer, M.D.
Casey Eye Institute
Portland, OR

Dale L. Phelps, M.D.
University of Rochester
Rochester, NY

NEI Representative

Donald F. Everett, M.A.
National Eye Institute
6120 Executive Boulevard, MSC 7164
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
Telephone: (301) 496-5983
Fax: (301) 402-0528

Steering Committee

Roy W. Beck, M.D., Ph.D
Jaeb Center for Health Research
Tampa, FL

Eileen Birch, Ph.D.
Retina Foundation of the Southwest
Dallas, TX

Susan A. Cotter, O.D.
Southern California College of Oprometry
Fullerton, CA

Donald F. Everett, M.A.
National Eye Institute
Bethesda, MD

Richard W. Hertle, M.D.
Pediatric Ophthalmology Associate, Inc
Colombus, OH

Jonathan M. Holmes, M.D.
Mayo Clinic
Rochester, MN

Pamela S. Moke, M.S.P.H.
Jaeb Center for Health Research
Tampa, FL

Michael X. Repka, M.D.
Johns Hopkins University
Baltimore, MD

Mitchll M. Scheiman, O.D.
Pennsylvania College of Optometry
Philadelphia, PA

Last Updated: 3/15/2004