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Trial Comparing Daily Atropine Versus Weekend Atropine

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ClinicalTrials.gov Identifier: NCT00094614
Recruitment Status : Completed
First Posted : October 22, 2004
Last Update Posted : March 25, 2010
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by:
Jaeb Center for Health Research

Brief Summary:

The goals of this study are:

  • To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine.
  • To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.

Condition or disease Intervention/treatment Phase
Amblyopia Drug: Atropine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine
Study Start Date : June 2002
Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia




Primary Outcome Measures :
  1. Visual acuity


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < 7 years
  • Able to measure surrounded single optotype visual acuity using the ATS single-surround HOTV protocol (this will in effect exclude all patients <2 years old and many <3 years old)
  • Amblyopia associated with strabismus, anisometropia, or both
  • If anisometropia is present (as per protocol definition), refractive error corrected with spectacles for a minimum of 4 weeks
  • Visual acuity in the amblyopic eye < 20/40 and >20/80
  • Visual acuity in the sound eye > 20/40 and inter-eye acuity difference >3 logMAR lines

Exclusion Criteria:

  • Amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
  • Myopia more than a spherical equivalent of -6.00 D in the amblyopic eye
  • Myopia more than a spherical equivalent of -0.50 D in the sound eye

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): NCT00094614


Locations
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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
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Study Chair: Michael X Repka, MD Wilmer Eye Institute
Study Chair: Jonathan M Holmes, MD Mayo Clinic Department of Ophthalmology

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00094614     History of Changes
Other Study ID Numbers: NEI-94
2U10EY011751 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2004    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: April 2006
Additional relevant MeSH terms:
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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