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

NCT ID: NCT00094679

Last Updated: 2010-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2002-09-30

Brief 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.

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.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2hrs daily patching

2 hours patching per day to cover the sound eye

Group Type: ACTIVE_COMPARATOR

Eye patch

Intervention Type: DEVICE

adhesive patch to cover the sound eye

6hrs daily patching

6 hours per day patching to cover the sound eye

Group Type: ACTIVE_COMPARATOR

Eye patch

Intervention Type: DEVICE

adhesive patch to cover the sound eye

Interventions

Eye patch

adhesive patch to cover the sound eye

Intervention Type: DEVICE

Other Intervention Names

Coverlet; Opticlude

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Jaeb Center for Health Research

Principal Investigators

Michael X Repka, M.D.

Role: STUDY_CHAIR

Wilmer Eye Institute

Locations

Wilmer Eye Institute

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12742836 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20451898 (View on PubMed)

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ATS2B

Identifier Type: -

Identifier Source: org_study_id