Amblyopia Clinical Trial
Official title:
A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia
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 minimal patching
(2 hours) for moderate 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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