An Observational Study on Recurrence of Amblyopia After Discontinuation of Treatment

Purpose | Background | Description | Patient Eligibility | Recruitment Status | Current Status | Results | Publications | 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.

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

Last Updated: 3/15/2004