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Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children

Recruitingn/aAges 5 Years - 8 YearsAllS-Alpha Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Single vision spectacles
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Where

5 sites
Kangbuk Samsung Hospital
Seoul, South Korea
Seoul Asan Medical Center
Seoul, South Korea
Hallym University Dongtan Sacred heart Hospital
Hwaseong-si, South Korea
Chung-Ang University Gwang Myeong Hospital
Gwangmyeong, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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