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

Last updated: March 23, 2010
Sponsor: Jaeb Center for Health Research
Overall Status: Completed

Phase

3

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

N/A

Clinical Study ID

NCT00315198
NEI-114
2U10EY011751
5U10EY011751
  • Ages 3-6
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, visualacuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMARlines.

  • Spectacles, if needed, must be worn for at least 16 weeks or until visual acuitydocumented to be stable.

Exclusion

Exclusion Criteria:

  • Prior amblyopia treatment other than spectacles in the past month.

  • More than one month of amblyopia treatment in the past 6 months.

Study Design

Total Participants: 425
Study Start date:
February 01, 2005
Estimated Completion Date:
December 31, 2007

Study 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.

Connect with a study center

  • Indiana University School of Optometry

    Bloomington, Indiana 47405
    United States

    Site Not Available

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota 55905
    United States

    Site Not Available

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