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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

April 14, 2006
March 23, 2010
February 2005
December 2007   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Visual acuity
Complete list of historical versions of study NCT00315198 on ClinicalTrials.gov Archive Site
Visual acuity [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Amblyopia
  • Device: Eye Patch
    2 hours daily patching
    Other Name: Coverlet, 3M Opticlude, Ortopad®
  • Procedure: Near activities
    near visual activities while patching
  • Procedure: Distance activities
    distance visual activities while patching
  • Active Comparator: Near activities
    2 hours of daily patching combined with near visual activities while patching
    Interventions:
    • Device: Eye Patch
    • Procedure: Near activities
  • Active Comparator: Distance activities
    2 hours of daily patching combined with distance visual activities while patching
    Interventions:
    • Device: Eye Patch
    • Procedure: Distance activities

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
3 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315198
NEI-114, 2U10EY011751, 5-U10 EY 11751
Yes
Roy W. Beck, M.D., Ph.D., Executive Director, Jaeb Center for Health Research
Jaeb Center for Health Research
National Eye Institute (NEI)
Study Chair: Don Lyon, O.D. Indiana University School of Optometry
Study Chair: Jonathan M. Holmes, M.D. Mayo Clinic Department of Ophthalmology
Jaeb Center for Health Research
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP