An interventional study of SAT-001 and Single vision spectacles in Myopia, sponsored by S-Alpha Therapeutics, Inc.. Recruiting at 1 site in South Korea. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by S-Alpha Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 110 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →S-Alpha Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Meet the following refractive criteria by cycloplegic refraction
Exclusion Criteria:
SAT-001(Software as Medical Device)+single vision spectacles
Device: SAT-001
Wearing single vision spectacles
Other: Single vision spectacles
Device: SAT-001(a Software as Medical Device) Using SAT-001 application for 48 weeks and wearing single vision spectacles
Wearing single vision spectacles
Change 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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S-Alpha Therapeutics, Inc.