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

Amblyopia Clinical Trial

— ATS2B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094679
• Other study ID #: ATS2B
• Secondary ID: 2U10EY011751
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2004
• Last updated: September 8, 2010
• Start date: May 2001
• Est. completion date: September 2002

Study information

• Verified date: September 2010
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: September 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Eye patch
adhesive patch to cover the sound eye

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity improvement		17 weeks	No