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Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia (ATS2B)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by:
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00094679
First received: October 21, 2004
Last updated: September 8, 2010
Last verified: September 2010
History of Changes
  Purpose

The goals of this study are:

  • To determine whether the visual acuity improvement obtained with part-time (6 hours) patching is equivalent to the visual acuity improvement obtained with minimal patching (2 hours) for moderate amblyopia.
  • To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching.
  • To identify factors that may be associated with successful treatment of amblyopia with patching.

Condition Intervention Phase
Amblyopia
 Device: Eye patch
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia

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

Primary Outcome Measures:
  • Visual acuity improvement [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: May 2001
Study Completion Date: September 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2hrs daily patching
2 hours patching per day to cover the sound eye
 Device: Eye patch
adhesive patch to cover the sound eye
Other Names:
  • Coverlet
  • Opticlude
Active Comparator: 6hrs daily patching
6 hours per day patching to cover the sound eye
 Device: Eye patch
adhesive patch to cover the sound eye
Other Names:
  • Coverlet
  • Opticlude

Detailed Description:

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally held that the response to treatment is best when it is instituted at an early age, particularly by age two or three, and is poor when attempted after eight years of age.

For moderate amblyopia, patching is the most commonly prescribed treatment although other modalities such as atropine penalization are also prescribed. There is no specific patching regimen that is widely accepted for treatment of moderate amblyopia and limited or no data available to favor the use of one specific regimen; both minimal occlusion (e.g., 2 hours per day) and six or more hours per day of patching are prescribed in clinical practice.

The study is a randomized trial comparing daily patching regimes for children with moderate amblyopia. It will consist of about 160 children. Patients in the moderate (20/40-20/80) group will patch part-time (6 hours) or minimal time (2 hours) of each day for the 4-month study period. There are at least two follow up visits during the 4-month period. Visual acuity is the major study outcome. It is assessed at the 4-month exam.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be less than 7 years of age with the original cause of amblyopia as strabismus or anisometropia.
  • Visual Acuity in the amblyopic eye must be between 20/40 and 20/80.
  • Visual acuity in the sound eye of 20/40 or better.
  • There must be at least 3 lines of acuity difference between the two eyes.

Exclusion Criteria:

  • Patching treatment (other than spectacles) within six months prior to enrollment and other amblyopia treatment of any type used within one month prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094679

Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Sponsors and Collaborators
Jaeb Center for Health Research
National Eye Institute (NEI)
Investigators
Study Chair: Michael X Repka, M.D. Wilmer Eye Institute
  More Information

Publications:

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

Responsible Party: Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00094679     History of Changes
Other Study ID Numbers: ATS2B, 2U10EY011751
Study First Received: October 21, 2004
Last Updated: September 8, 2010
Health Authority: United States: Federal Government

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 May 23, 2013