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Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children
Sponsor: S-Alpha Therapeutics, Inc.
Summary
The objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients.
Official title: A Multi-center, Open-label, Controlled Extension Study to Evaluate the Rebound Effect and Long-term Safety of Software SAT-001 for the Inhibition of Myopia Progression and Treatment in Pediatric Patients With Myopia
Key Details
Gender
All
Age Range
5 Years - 8 Years
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2024-12-16
Completion Date
2026-07-30
Last Updated
2025-01-09
Healthy Volunteers
No
Conditions
Interventions
Single vision spectacles
Other interventions for myopia treatment, except for glasses, will not be provided.
Locations (5)
Kangbuk Samsung Hospital
Seoul, Choose One..., South Korea
Seoul Asan Medical Center
Seoul, Choose One..., South Korea
Hallym University Dongtan Sacred heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
Chung-Ang University Gwang Myeong Hospital
Gwangmyeong, South Korea
Gachon University Gil Medical Center
Incheon, South Korea