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

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ClinicalTrials.gov Identifier: NCT00094692
Recruitment Status : Completed
First Posted : October 22, 2004
Last Update Posted : March 24, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Amblyopia Device: Eye patch Device: spectacles Drug: atropine Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Study Start Date : October 2002
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Visual acuity improvement

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094692


Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
United States, Pennsylvania
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Jaeb Center for Health Research
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
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00094692     History of Changes
Other Study ID Numbers: NEI-93
2U10EY011751 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2004    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: May 2007

Keywords provided by Jaeb Center for Health Research:
Amblyopia
Patching
Spectacles

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action