Study on the safety and rebound effect of SAT-001 for myopia in children
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
This study is testing if a new software treatment for myopia can safely help children aged 5 to under 9 years old without causing problems once they stop using it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 8 Years |
| Sex | All |
| Sponsor | S-Alpha Therapeutics, Inc. Industry-sponsored |
| Locations | 5 sites (Seoul, Choose One... and 4 other locations) |
| Trial ID | NCT06742268 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the long-term safety and rebound effect of SAT-001, a Software as a Medical Device (SaMD) designed to inhibit myopia progression in children. It follows participants aged 5 to less than 9 years who completed a previous trial, assessing changes in their refractive error over a 6-month period. The study will include both treatment and control groups, with participants continuing to wear spectacles during the extension phase. The primary focus is on understanding the rebound effect that may occur after treatment cessation.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to less than 9 years who completed the previous SAT-001 trial and have legal guardians willing to provide informed consent.
Not a fit: Patients who had less than 70% compliance in the previous trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer and more effective treatment strategies for managing myopia in children.
How similar studies have performed: Previous studies on myopia treatments have shown varying results, but the specific focus on the rebound effect in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who have completed the previous clinical trial (SAT001-KP-002), and their legal guardians who agree to participate in this extension study and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding) Exclusion Criteria: * Participants in the study group of the previous clinical trial (SAT001-KP-002) with a compliance rate of less than 70% (overall compliance throughout the study period). * Other reasons for participation in the trial at the discretion of the investigator
Where this trial is running
Seoul, Choose One... and 4 other locations
- Kangbuk Samsung Hospital — Seoul, Choose One..., South Korea (Recruiting)
- Seoul Asan Medical Center — Seoul, Choose One..., South Korea (Not_yet_recruiting)
- Hallym University Dongtan Sacred heart Hospital — Hwaseong-si, Gyeonggi-do, South Korea (Recruiting)
- Chung-Ang University Gwang Myeong Hospital — Gwangmyeong, South Korea (Not_yet_recruiting)
- Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
Study contacts
- Principal investigator: Paik, MD — Gachon University Gil Medical Center
- Study coordinator: Jihye Lee, MSc
- Email: sophie@salphadtx.com
- Phone: (+82) 2-3487-3923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.