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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00000170 |
Extended Follow up of Study Patients
Condition | Intervention | Phase |
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Amblyopia |
Drug: Atropine Device: Eye Patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia |
Enrollment: | 419 |
Study Start Date: | April 1999 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Patching: Active Comparator |
Device: Eye Patch
Patching
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Atropine: Active Comparator
Atropine
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Drug: Atropine
Atropine
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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.
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director ) |
Study ID Numbers: | NEI-73, 5-U10 EY 11751 |
Study First Received: | September 23, 1999 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00000170 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Amblyopia patching atropine |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia Eye Diseases |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Atropine |
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Nervous System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Cholinergic Agents |
Pharmacologic Actions Muscarinic Antagonists Adjuvants, Anesthesia Mydriatics Autonomic Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |