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Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old (ATS8)
This study has been completed.
First Received: April 14, 2006   Last Updated: May 8, 2009   History of Changes
Sponsor: National Eye Institute (NEI)
Information provided by: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00315302
  Purpose

The purpose of the study is:

  • To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
  • To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Condition Intervention Phase
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

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • Visual acuity for both amblyopic and sound eyes [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Atropine: Active Comparator
Atropine 1% once each weekend day in the sound eye
Drug: Atropine
Atropine 1% once each weekend day
Atropine plus plano: Active Comparator
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye
Drug: Atropine
Atropine 1% once each weekend day
Device: Plano Lens
Plano lens for the sound eye

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
  • Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
  • Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

  • Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
  • No myopia in amblyopic eye
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315302

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: David Weakley, M.D. UT Southwestern Medical Center
Study Chair: Susan A. Cotter, O.D. Southern California College of Optometry
  More Information

Additional Information:
Publications:
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: May 8, 2009
ClinicalTrials.gov Identifier: NCT00315302     History of Changes
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):
Amblyopia
Atropine
Plano lens

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

ClinicalTrials.gov processed this record on November 20, 2009