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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00094744
First received: October 22, 2004
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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.

Condition Intervention Phase
Amblyopia
Device: Eye patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Visual acuity improvement at 17wks. [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: May 2001
Study Completion Date: September 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094744

Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: Michael X Repka, M.D. Wilmer Eye Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00094744     History of Changes
Other Study ID Numbers: NEI-88, 2U10EY011751
Study First Received: October 22, 2004
Last Updated: September 8, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014