Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds - Full Text View

Sponsor:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00315328

Purpose

The purpose of this study is:

To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
To determine the maximum improvement in vision of the amblyopic eye with each treatment.
To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Condition	Intervention	Phase
Amblyopia	Drug: Atropine Device: Patching Procedure: Near activities	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Resource links provided by NLM:

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

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

Primary Outcome Measures:

Visual acuity for both amblyopic and sound eyes [ Time Frame: 17 weeks for amblyopic eye, and 17 weeks or 19 weeks for sound eye ] [ Designated as safety issue: No ]

Enrollment:	193
Study Start Date:	August 2005
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Patching: Active Comparator Patching 2 hours per day plus near activities for one hour while patching	Device: Patching Patching 2 hours per day Procedure: Near activities near visual activities for at least one hour per day
Atropine: Active Comparator Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day	Drug: Atropine Atropine 1% each weekend day in the sound eye Procedure: Near activities near visual activities for at least one hour per day

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Eligibility

Ages Eligible for Study:	7 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 7 to <13 years
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye 19 to 71 letters on E-ETDRS (20/40 to 20/400 inclusive)
Visual acuity in the sound eye 79 letters or better on E-ETDRS (20/25 or better)
Interocular difference >=15 letters (3 lines)
Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

Enrolled into the main study
Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
Birth weight >1500 grams
No history of CNS disease (e.g. IVH, PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria:

Amblyopia treatment (other than spectacles) in the last 6 months
Myopia (more than -0.25D spherical equivalent) in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315328

Locations

United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Study Chair:	Richard W. Hertle, M.D.	Children's Hospital of Pittsburgh
Study Chair:	Mitchell M. Scheiman, O.D.	Pennsylvania College of Optometry

More Information

Additional Information:

NEI Clinical Studies Database This link exits the ClinicalTrials.gov site

PEDIG public website This link exits the ClinicalTrials.gov site

Publications:

Scheiman MM, Hertle RW, Kraker RT, Beck RW, Birch EE, Felius J, Holmes JM, Kundart J, Morrison DG, Repka MX, Tamkins SM; Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol. 2008 Dec;126(12):1634-42.

Responsible Party:	Jaeb Center for Health Research ( Boy W. Beck, M.D., Ph.D., Executive Director )
Study ID Numbers:	NEI-119, 5-U10 EY 11751
Study First Received:	April 14, 2006
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00315328 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):

Amblyopia
Atropine
Patching

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 February 08, 2010