Study on the safety and rebound effect of SAT-001 for myopia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kangbuk Samsung Hospital
  Seoul, Choose One..., South Korea Recruiting
• Hallym University Dongtan Sacred heart Hospital
  Hwaseong-si, Gyeonggi-do, South Korea Recruiting
• Gachon University Gil Medical Center
  Incheon, South Korea Recruiting
• Seoul Asan Medical Center
  Seoul, Choose One..., South Korea Not yet recruiting
• Chung-Ang University Gwang Myeong Hospital
  Gwangmyeong, South Korea Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.