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

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094744
• Other study ID #: NEI-88
• Secondary ID: 2U10EY011751
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2004
• Last updated: September 8, 2010
• Start date: May 2001
• Est. completion date: September 2003

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: September 2003
• Est. primary completion date: July 2003
• 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 (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 Design

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Eye patch
adhesive eye patch used 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)

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. — View Citation

Outcome

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