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Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000170
First Posted: September 24, 1999
Last Update Posted: March 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
  Purpose
  • To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy
  • To develop more precise estimates of the success rates of amblyopia treatment
  • To identify factors that may be associated with successful treatment of amblyopia
  • To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available

Extended Follow up of Study Patients

  • Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
  • Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

Condition Intervention Phase
Amblyopia Drug: Atropine Device: Eye Patch Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Visual acuity in the amblyopic eye [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Visual acuity in the amblyopic eye [ Time Frame: 24 months ]
  • Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years [ Time Frame: age 10 years and age 15 years ]
  • Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care [ Time Frame: age 10 years and age 15 years ]

Enrollment: 419
Study Start Date: April 1999
Study Completion Date: August 2013
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patching Device: Eye Patch
Patching
Active Comparator: Atropine
Atropine
Drug: Atropine
Atropine

Detailed Description:

Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often persists in adulthood. It is reported to be the leading cause of vision loss in one eye in the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating that both improved means of detection and treatment are needed.

Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled. Despite the common occurrence of amblyopia, there is little quality data on treatment of this condition. Thus, there is much to be learned about the course of treated amblyopia, to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment.

Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the sound eye. Occlusion therapy is subject to problems of compliance, due to the child's dislike of wearing a patch for visual, skin irritation, and social/psychological reasons. There is evidence that compliance may be one of, if not, the most important determinant of success of amblyopia therapy.

An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the pupils and blurs the image seen by the sound eye, has been known for almost a century. This method has been widely used for the management of occlusion treatment failures and for maintenance therapy. However, it has seen little use as a primary treatment for amblyopia. Clinical experience has found that it has a high acceptability to patients and parents, and hence high compliance. In addition to its acceptability, pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes, which may have safety and other functional implications. There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes (binocularity).

Available data suggest that the success rate with drug therapy is as good as, if not better than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If this is true, for many children with amblyopia, drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents. Despite data to support the use of drug therapy as a primary therapy for amblyopia, it has gained only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed.

Regardless of whether the trial determines that one therapeutic approach is better than the other, the data that are collected will provide valuable information about the course of amblyopia treatment that is not presently available. The study also is expected to provide data that will help to determine whether factors such as age, refractive status, cause of amblyopia, or fixation pattern should be considered in determining which procedure is best for a given patient.

Extended Follow-up of Study Patients

The extended follow up study consists of annual visits prior to age 10, followed by a visit at age 10 years and a visit at age 15 years. There is no amblyopia treatment that is required during the extended follow up period.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
  • Visual acuity in the amblyopic eye must be between 20/40 and 20/100
  • Visual acuity in the sound eye or 20/40 or better
  • At least 3 lines of acuity difference between the two eyes

Exclusion Criteria:

  • More than two months of amblyopia therapy in the past two years
  • Myopia (more than -0.50 D)
  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): NCT00000170


Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Sponsors and Collaborators
Jaeb Center for Health Research
National Eye Institute (NEI)
Investigators
Study Chair: Michael X. Repka, M.D. Wilmer Eye Institute
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00000170     History of Changes
Other Study ID Numbers: NEI-73
2U10EY011751 ( U.S. NIH Grant/Contract )
5U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 1999
First Posted: September 24, 1999
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by Jaeb Center for Health Research:
Amblyopia
patching
atropine

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