Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia

A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe 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 full-time patching (all or all but one waking hour) for severe 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 severe amblyopia, it is generally accepted that occlusion with patching is the standard of care. Other modalities of treatment, such as atropine penalization and optical penalization, are widely considered insufficient as initial treatments for severe amblyopia. However, controversy exists with regard to how many hours per day of patching should be prescribed. Advocates of full-time patching purport that such a regimen is needed to restore visual acuity more rapidly and more effectively. Advocates of part-time patching believe it to be better tolerated by the child and family, therefore producing less stress on the parent-child relationship and producing better results through better compliance. Part-time patching may also promote the development of binocularity in patients who have "straight-eyes", reduce the chance of a straight-eyed patient developing manifest strabismus or losing stereopsis, and reduce the incidence of reverse- or occlusion-amblyopia.

The study is a randomized trial comparing daily patching regimes for children with severe amblyopia. It will consist of about 160 children. Patients in the severe (20/100 to 20/400) group will patch part-time (6 hours) or full-time (all or all but one waking hour) 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): 175
• 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 (a refractive error difference of more than one diopter between the two eyes.)
• Visual acuity in the amblyopic eye must be between 20/100 and 20/400.
• 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
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 6hrs daily patching; 6 hours per day of patching in the sound eye	Device: Eye patch; adhesive eye patch used to cover the sound eye; Other Names: Coverlet; Opticlude
ACTIVE_COMPARATOR: Full-time daily patching; Patching of the sound eye all but one waking hour	Device: Eye patch; adhesive eye patch used to cover the sound eye; Other Names: Coverlet; Opticlude

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual acuity improvement at 17wks.	17 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Holmes JM, Kraker RT, Beck RW, Birch EE, Cotter SA, Everett DF, Hertle RW, Quinn GE, Repka MX, Scheiman MM, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology. 2003 Nov;110(11):2075-87. doi: 10.1016/j.ophtha.2003.08.001.
• 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, 2003
• Study Completion (ACTUAL): September 1, 2003

Study Registration Dates

• First Submitted: October 22, 2004
• First Submitted That Met QC Criteria: October 22, 2004
• First Posted (ESTIMATE): October 25, 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: NEI-88; 2U10EY011751 (U.S. NIH Grant/Contract)