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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00094679 |
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 Minimal-Time Patching for Moderate Amblyopia |
Estimated Enrollment: | 189 |
Study Start Date: | May 2001 |
Estimated Study Completion Date: | May 2002 |
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 moderate amblyopia, patching is the most commonly prescribed treatment although other modalities such as atropine penalization are also prescribed. There is no specific patching regimen that is widely accepted for treatment of moderate amblyopia and limited or no data available to favor the use of one specific regimen; both minimal occlusion (e.g., 2 hours per day) and six or more hours per day of patching are prescribed in clinical practice.
The study is a randomized trial comparing daily patching regimes for children with moderate amblyopia. It will consist of about 160 children. Patients in the moderate (20/40-20/80) group will patch part-time (6 hours) or minimal time (2 hours) 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-90 |
Study First Received: | October 21, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00094679 |
Health Authority: | United States: Federal Government |
Sensation Disorders Motor neuro-ophthalmic disorders Vision Disorders Eye Diseases Strabismus Central Nervous System Diseases Brain Diseases |
Ocular motility disorders Signs and Symptoms Ocular Motility Disorders Amblyopia Neurologic Manifestations Anisometropia Refractive Errors |
Nervous System Diseases Cranial Nerve Diseases |