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

NCT ID: NCT00094744

Last Updated: 2010-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2003-09-30

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 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.

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.

Conditions

Amblyopia

Study Design

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

Study Groups

6hrs daily patching

6 hours per day of patching in the sound eye

Group Type: ACTIVE_COMPARATOR

Eye patch

Intervention Type: DEVICE

adhesive eye patch used to cover the sound eye

Full-time daily patching

Patching of the sound eye all but one waking hour

Group Type: ACTIVE_COMPARATOR

Eye patch

Intervention Type: DEVICE

adhesive eye patch used to cover the sound eye

Interventions

Eye patch

adhesive eye patch used 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 (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.

• 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

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.

Reference Type: BACKGROUND

PMID: 14597512 (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

NEI-88

Identifier Type: -

Identifier Source: org_study_id