The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia
Myopic pediatric prevalence rate come to increase rapidly globally. This is a clinical trial to explore the safety and effectiveness of SAT-001(as a Software as Medical Device) developed for the treatment of myopia through suppressing the progress myopia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Using SAT-001 application for 48 weeks and wearing glasses or not
HanGil Eye Hospital
Incheon, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, South Korea
Change in cycloplegic Refraction Error
Time frame: Baseline, 24 weeks, 48 weeks
Change in axial length
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
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Samsung Medical Center
Seoul, South Korea
Seoul Asan Medical Center
Seoul, South Korea