The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.
Myopia is a common refractive error affecting approximately 30 % of the global population, with even higher prevalence in Asian countries including Korea. This study is a confirmatory clinical trial designed to evaluate the efficacy and safety of SAT-001 for slowing the progression of myopia in children, based on the results of the exploratory clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Device: SAT-001(a Software as Medical Device) Using SAT-001 application for 48 weeks and wearing single vision spectacles
Wearing single vision spectacles
Gachon University Gil Hospital
Incheon, South Korea
RECRUITINGChange in Axial Length
Time frame: Baseline, 48weeks
Change in Axial Length
Time frame: Baseline, 12weeks, 24weeks, 36weeks
Change in cycloplegic Spherical Equivalent Refractive Error
Time frame: Baseline, 24weeks, 48weeks
Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia)
Time frame: Baseline, 24 weeks, 48 weeks
Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia)
Time frame: Baseline, 12weeks, 24weeks, 36weeks, 48weeks
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