Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old (ATS6)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00315198

First Posted: April 18, 2006

Last Update Posted: March 24, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Eye Institute (NEI)

Information provided by:

Jaeb Center for Health Research

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

Resource links provided by NLM:

MedlinePlus related topics: Amblyopia

U.S. FDA Resources

Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:

Visual acuity [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: 17 weeks ]


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

Arms	Assigned Interventions
Active Comparator: Near activities 2 hours of daily patching combined with near visual activities while patching	Device: Eye Patch 2 hours daily patching Other Name: Coverlet, 3M Opticlude, Ortopad® Procedure: Near activities near visual activities while patching
Active Comparator: Distance activities 2 hours of daily patching combined with distance visual activities while patching	Device: Eye Patch 2 hours daily patching Other Name: Coverlet, 3M Opticlude, Ortopad® 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

Information from the National Library of Medicine

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Ages Eligible for Study:	3 Years to 6 Years (Child)
Sexes Eligible for Study:	All
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

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): 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

Jaeb Center for Health Research

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

Additional Information:

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

Publications:

Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology. 2008 Nov;115(11):2071-8. doi: 10.1016/j.ophtha.2008.06.031. Epub 2008 Sep 11.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.

Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.


Responsible Party:	Roy W. Beck, M.D., Ph.D., Executive Director, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:	NCT00315198 History of Changes
Other Study ID Numbers:	NEI-114 2U10EY011751 ( U.S. NIH Grant/Contract ) 5U10EY011751 ( U.S. NIH Grant/Contract )
First Submitted:	April 14, 2006
First Posted:	April 18, 2006
Last Update Posted:	March 24, 2010
Last Verified:	May 2009

Keywords provided by Jaeb Center for Health Research:


amblyopia patching visual activities

Additional relevant MeSH terms:


Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders	Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms

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