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

A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia

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.

Study Overview

• Status: Completed
• Conditions: Amblyopia
• Intervention / Treatment: Device: Eye patch

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.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287-9028
      • Wilmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual acuity improvement	17 weeks

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: National Eye Institute (NEI)

Publications and helpful links

General Publications

• Repka MX, Beck RW, Holmes JM, Birch EE, Chandler DL, Cotter SA, Hertle RW, Kraker RT, Moke PS, Quinn GE, Scheiman MM; Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol. 2003 May;121(5):603-11. doi: 10.1001/archopht.121.5.603.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): July 1, 2002
• Study Completion (Actual): September 1, 2002

Study Registration Dates

• First Submitted: October 21, 2004
• First Submitted That Met QC Criteria: October 21, 2004
• First Posted (Estimate): October 22, 2004

Study Record Updates

• Last Update Posted (Estimate): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 8, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: ATS2B; 2U10EY011751 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No