Amblyopia Clinical Trial
Official title:
A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.
The value of "near visual activities" while patching for amblyopia is controversial. Some
pediatric eye care providers currently recommend that the child perform near visual tasks
while wearing a patch over the sound eye, while other pediatric eye care providers do not
prescribe any specific visual tasks to be performed while the patch is worn.
In previous randomized studies of patching doses for amblyopia conducted by the Pediatric
Eye Disease Investigator Group, near visual activities were incorporated into the prescribed
treatment regimes. Although different doses of patching, combined with near visual
activities, were successful in improving visual acuity in most children, it is unclear
whether concurrent near visual activities enhanced the effect of patching.
This study is designed as an efficacy study, making effort to maximize adherence to
treatment group assignments.
The study has been designed as a simple trial that, other than the type of amblyopia therapy
being determined through the randomization process, approximates standard clinical practice.
The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily
patching combined with near visual activities while patching and 2)2 hours of daily patching
combined with distance visual activities while patching.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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