An Observational Study on Recurrence of Amblyopia After Discontinuation of Treatment

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

Purpose

• To identify factors associated with recurrence to be considered in designing a subsequent trial
• To collect data to estimate the recurrence rate of amblyopia after treatment is discontinued

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.

After amblyopia has been successfully treated, there is no accepted standard of care for how it should be managed. Can treatment be stopped or is a period of maintenance therapy needed? At present, there are little quality data available on the recurrence rate of amblyopia and whether there are any factors that can predict which patients are likely to have a recurrence and which are not. Therefore, a prospective study warranted to provide an estimate of the amblyopia recurrence rate and associated factors.

Description

The observational study will determine the recurrence rate and factors associated with recurrence when treatment is discontinued in patients whose amblyopia has been successfully treated. It will consist of about 200 children. The study will last for 12 months and each child will have at least four follow up visits. Visual acuity is assessed at the 12-month exam.

Patient Eligibility

Patients must be less than 8 years of age with original cause of amblyopia (at start of current cycle of treatment) due to strabismus or anisometropia (a refractive error difference of more than one diopter between the two eye.) At time of enrollment child must have had continuous treatment for amblyopia in the last 3 months consisting of at least 2 hours per day of patching (14 hours per week) or at least one drop of atropine per week. At start of current treatment cycle, acuity in the amblyopic eye must be 20/40 or worse with at least 3 lines of acuity difference between the two eyes.

Patient Recruitment Status

Completed. Recruitment began in May 2001 and closed in November 2002 after 176 patients were enrolled

Current Status of Study

Completed.

Results

None. Manuscript to be submitted to Journal of AAPOS in March 2004

Publications

None.

Clinical Centers

Alabama
Frederick J. Elsas, M.D.
Alabama Ophthalmology Associates, P.C.
1000 South 19th Street
Birmingham, AL 35205

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.
Birmingham 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

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

Indiana
Naval Sondhi, M.D.
Derek T. Sprunger, M.D.
Indiana Medical Center
Department of Ophthalmology
Methodist Medical Plaza
201 Pennsylvania Parkway
Indianapolis, IN 46280

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

Iowa
Ronald V. Keech, M.D.
University of Iowa
200 Hawkins Drive
Iowa City, IA 52242-1091

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

Maryland
Stephen R. Glaser, M.D.
101 Lakeforest Boulevard, Suite 380
Gaithersburg, MD 20877

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.
Brian G. Mohney, M.D.
Melissa L. Rice, O.D.
Mayo Clinic
200 First Street, SW
Rochester, MN 55905

Stephen P. Christiansen, M.D.
Allison A. Jensen, 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

New Jersey
Michael F. Gallaway, O.D.
2401 Route 130 S
Cinnaminson, NJ 08077-3020

New York
Stanley W. Hatch, M.D.
Eye Care for the Adirondacks
Associates in Ophthalmology, PC
450 Margaret Street
Plattsburgh, NY 12901-1793

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, OH 43025

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

Oregon
David T. Wheeler, M.D.
Casey Eye Institute
3375 SW Terwilliger Boulevard
Portland, OR 97201-4197

Pennsylvania
Jane Covington Edmond, M.D.
Ellie L. Francis, O.D.
Brian J. Forbes, Ph.D.,M.D.
Monte D. Mills, M.D.
Graham E. Quinn, M.D.
Children's Hospital of Philadelphia
Wood Center, 1st Floor
Philadelphia, PA 19104

David I. Silbert, M.D.
Eye Specialists of Lancaster
140 North Pointe Boulevard
Lancaster, PA 17601

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

Mitchell M. Scheiman, O.D.
Brandy J. Scombordi-Raghu, 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
Priscilla M. Berry, M.D.
David R. Stager, Sr., M.D.
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: (401) 955-0809
Fax: (410) 955-8314
E-mail: mrepka@jhmi.edu

Data Coordinating 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://ats.jaeb.org

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

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

Other

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

Steering Committee

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

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

Donald F. Everett
National Eye Institute
Bethesda, MD

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

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

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

Michael X. Repka
Johns Hopkins University
Baltimore, MD

Mitchell M. Scheinman, O.D.
Pennsylvania College of Optometry
Philadelphia, PA

Last Updated: 3/15/2004