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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00315302 |
The purpose of the study is:
Condition | Intervention | Phase |
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Amblyopia |
Drug: Atropine Device: Plano Lens |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old |
Enrollment: | 240 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | January 2008 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Atropine: Active Comparator
Atropine 1% once each weekend day in the sound eye
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Drug: Atropine
Atropine 1% once each weekend day
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Atropine plus plano: Active Comparator
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye
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Drug: Atropine
Atropine 1% once each weekend day
Device: Plano Lens
Plano lens for the sound eye
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Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.
Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.
In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.
The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.
Ages Eligible for Study: | 3 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Southern California College of Optometry | |
Fullerton, California, United States, 92831 | |
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75235 |
Study Chair: | David Weakley, M.D. | UT Southwestern Medical Center |
Study Chair: | Susan A. Cotter, O.D. | Southern California College of Optometry |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director ) |
Study ID Numbers: | NEI-115, 5-U10 EY 11751 |
Study First Received: | April 14, 2006 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00315302 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Amblyopia Atropine Plano lens |
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 |