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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00315198
First received: April 14, 2006
Last updated: March 23, 2010
Last verified: May 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


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

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jaeb Center for Health Research
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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, 5-U10 EY 11751
Study First Received: April 14, 2006
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 21, 2014