Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
brief summary
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.
detailed description
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.
official title
A Multicenter, Randomized, Open-label, Controlled Pivotal Study to Evaluate the Efficacy and Safety of Software SAT-001 in Slowing Myopia Progression and Treatment in Pediatric Patients With Myopia