An Evaluation Of Treatment Of Amblyopia In Children 7 To <18 years old

Purpose

To determine the response rate of treatment of amblyopia in 7 to <18 year olds
To determine the frequency of recurrence of amblyopia in 7 to <18 year olds after discontinuation of amblyopia treatment

Background

Most eye care practitioners believe that there is an age beyond which attempting to treat amblyopia is futile. It is generally held that the response to treatment is best when it is instituted at an early age and is poor when attempted after eight years of age. There has not been a prospective clinical trial conducted with appropriate rigor that has evaluated the effect of treatment of amblyopia in children aged 7 years or older. Although available data on the efficacy of amblyopia treatment of older children are limited, there is reason to believe from clinical observations and published case series that treatment could have benefit. In a pilot study of patients 10 to <18 years old with amblyopia, we found that 37 percent of 52 patients showed improvement in the amblyopic eye acuity of 2 or more lines after treatment with part-time patching. however, without a concurrent randomized control group, the results are not conclusive. although the literature and our pilot study provide support that amblyopia can be improved with treatment, neither the response rate to treatment nor the recidivism rate after cessation of treatment can be well defined. despite the evidence that amblyopia therapy can be effective in older children, many clinicians do not attempt treatment under the assumption that it will be unsuccessful. therefore, a clinical trial is needed to provide the requisite data to establish clinical practice guidelines for the treatment of amblyopia in older children. in addition to its importance for patient management, the trial's results will meet the demand for cost efffectiveness by health maintenance organizations, large employers, and insurers.

Description

The study is a randomized trial comparing patients treated with spectacles only (Control Group) to patients undergoing active treatment (patching, near activities while patching, and atropine for children under the age of 13) in addition to spectacles (Active Treatment Group). It will enroll a minimum of 90 patients in each of the age groups of 7 to <9, 9 to <11, 11 to <13, and 13 to <18 years old. patients have follow up visits every 6 weeks (up to a maximum of 24 weeks) until they are classified as either responders or nonresponders based on amblyopic eye visual acuity.

At the end of the randomized trial:

Patients who did not respond to treatment end follow up
Patients who responded to treatment continue in their respective treatment groups until visual acuity stops improving.

Once there is no further improvement in visual acuity:

Patients in the Control Group end follow up
Patients in the Active Treatment Group discontinue active treatment and have follow up visits at 13 weeks, 26 weeks, and 52 weeks timed from treatment discontinuation.

Patient Eligibility

Patients must be aged 7 to <18 years and have amblyopia associated with strabismus, anisometropia, or both. visual acuity in the amblyopic eye must be 20/40 to 20/400 inclusive and visual acuity in the sound eye must be 20/25 or better. patients must not have received amblyopia treatment (other than spectacles) in the past month or more than one month of amblyopia treatment in the last 6 months.

Patient Recruitment Status

Completed. Recruitment began in October 2002 and closed January 2004 after 507 patients were randomized.

Current Status of Study

Ongoing. Follow up of patients will continue through August 2005.

Results

None

Publications

None.

Clinical Centers

California
Carmen N. Barnhardt, O.D.
Raymond H. Chu, O.D.
Susan A. Cotter, O.D.
Susan M. Shin, O.D.
Southern California College of Optometry
2575 Yorba Linda Blvd
Fullerton, CA 92831-1699

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

Andrew J. Levada, M.D.
The Eye Care Group, PC
1201 W Main St STE 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
Don W. Lyon, O.D.
Indiana University
School of Optometry
Indianapolis Eye Care Center
501 Indian Ave Ste 100
Indianapolis, IN 46202

Iowa
Donny W. Suh, M.D.
Wolfe Clinic
6000 University Ave
West Des Moines, IA 50266-8203

Kansas
David A. Johnson, M.D., Ph.D.
Eye Clinic of Wichita
655 North Woodlawn
Wichita, KS 67208

Michigan
Patrick J. Droste, M.D.
Robert J. Peters, O.D.
Pediatric Ophthalmology, P.C.
5050 Cascade Road SE
Grand Rapids, MI 49546

Minnesota
Jonathan M. Holmes, M.D.
Brian G. Mohney, M.D.
Melissa L. Rice, O.D.
Mayo Clinic
200 1st St SW
Rochester, MN 55905-0002

Ohio
Don L. Bremer, M.D.
Richard W. Hertle, M.D.
Pediatric Ophthalmology Associates, Inc.
555 S 18th St STE 4C
Columbus, OH 43025

Pennsylvania
Don D. Blackburn, O.D.
David I. Silbert, M.D.
Eric L. Singman, M.D., Ph.D.
Family Eye Group
2110 Harrisburg Pike, Suite 215
Lancaster, PA 17604

Nicholas A. Sala, D.O.
Pediatric Ophthalmology of Erie
2201 W 38th St
Erie, PA 16506-4501

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

Rhode Island
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 Rd STE 140A
Dallas, TX 75225-6203

Virginia
Earl R. Crouch, Jr., M.D.
Eastern Virginia Medical School
880 Kempsville Road, Suite 2500
Norfolk, VA 23502-3942

Resource Centers

Co-Chairman
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 N. Wolfe Street
Baltimore, MD 21287-9028
Telephone: (410) 955-8314
Fax: (410) 955-0809
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

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 Optometry
Fullerton, CA

Donald F. Everett, M.A.
Bethesda, MD

Richard W. Hertle, M.D.
Pediatric Ophthalmology Associates, 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

Graham E Quinn, M.D.
Children's Hospital of Philadelphia
Philadelphia, PA

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

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

Last Updated: 3/15/2004

This page was last modified in October 2008

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