Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old - Full Text View

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00315198

Purpose

Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.

Condition	Intervention	Phase
Amblyopia	Device: Eye Patch Procedure: Near activities Procedure: Distance activities	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

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

Primary Outcome Measures:

Visual acuity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Enrollment:	425
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Near activities: Active Comparator 2 hours of daily patching combined with near visual activities while patching	Device: Eye Patch 2 hours daily patching Procedure: Near activities near visual activities while patching
Distance activities: Active Comparator 2 hours of daily patching combined with distance visual activities while patching	Device: Eye Patch 2 hours daily patching Procedure: Distance activities distance visual activities while patching

Detailed Description:

The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.

In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.

This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.

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 regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.

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 due to 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:

Prior amblyopia treatment other than spectacles in the past month.
More than one month of amblyopia treatment in the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315198

Locations

United States, Indiana
Indiana University School of Optometry
Bloomington, Indiana, United States, 47405
United States, Minnesota
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Study Chair:	Don Lyon, O.D.	Indiana University School of Optometry
Study Chair:	Jonathan M. Holmes, M.D.	Mayo Clinic Department of Ophthalmology

More Information

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

PEDIG public website This link exits the ClinicalTrials.gov site

Responsible Party:	Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director )
Study ID Numbers:	NEI-114, 5-U10 EY 11751
Study First Received:	April 14, 2006
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00315198
Health Authority:	United States: Federal Government

Keywords provided by National Eye Institute (NEI):

amblyopia
patching
visual activities

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Vision Disorders
Amblyopia

Eye Diseases
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009