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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00094744 |
The goals of this study are:
Condition | Intervention | Phase |
---|---|---|
Amblyopia Strabismus Anisometropia |
Device: Eye patch |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial Comparing Part-Time Versus Full-Time Patching for Severe Amblyopia |
Estimated Enrollment: | 175 |
Study Start Date: | May 2001 |
Estimated Study Completion Date: | April 2003 |
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.
Ages Eligible for Study: | 3 Years to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NEI-88 |
Study First Received: | October 22, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00094744 History of Changes |
Health Authority: | United States: Federal Government |
Sensation Disorders Vision Disorders Eye Diseases Strabismus Central Nervous System Diseases Brain Diseases Signs and Symptoms |
Ocular Motility Disorders Amblyopia Neurologic Manifestations Anisometropia Refractive Errors Motor Neuro-ophthalmic Disorders |
Sensation Disorders Vision Disorders Eye Diseases Strabismus Nervous System Diseases Central Nervous System Diseases Brain Diseases |
Signs and Symptoms Ocular Motility Disorders Amblyopia Neurologic Manifestations Cranial Nerve Diseases Anisometropia Refractive Errors |