An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old

March 23, 2010 updated by: Jaeb Center for Health Research

An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds

The goals of this study are:

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 effectiveness by health maintenance organizations, large employers, and insurers.

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.

Study Type

Interventional

Enrollment

507

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287-9028
        • Wilmer Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Pennsylvania College of Optometry
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual acuity improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

National Eye Institute (NEI)

Investigators

  • Study Chair: Richard W. Hertle, M.D., University of Pittsburgh
  • Study Chair: Mitchell M. Scheiman, O.D., Pennsylvania College of Optometry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 21, 2004

First Submitted That Met QC Criteria

October 21, 2004

First Posted (Estimate)

October 22, 2004

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 23, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-93
  • 2U10EY011751 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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