RecruitingNCT06742268

Extension Study on 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

Sponsor

S-Alpha Therapeutics, Inc.

Enrollment

40 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

Myopia

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.

Eligibility

Min Age: 5 YearsMax Age: 8 Years

Inclusion Criteria1

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 Criteria2

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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