What this Trial Is About

This research aims to collect data on the rebound effect and long-term safety of SAT-001, a software device under development to slow myopia progression in children aged 5 to less than 9 years. The study focuses on pediatric patients who completed a previous trial evaluating this device, as myopia progression can continue for over two years and may accelerate after stopping treatment. Understanding this rebound effect is important for developing effective treatment strategies for childhood myopia. This multi-center, open-label, controlled observational extension study follows 40 participants from both treatment and control groups of the prior trial. Participants will continue wearing single vision spectacles, the conventional treatment for myopia, during the 6-month extension period after completing the original study. The trial excludes those with less than 70% compliance in the previous study and does not provide other myopia treatments besides glasses. During the 6-month follow-up, researchers will measure changes in the refractive error of the eye and axial length at 12 and 24 weeks compared to baseline to assess the rebound effect and safety of SAT-001. Participants and their guardians will provide informed consent, and safety and long-term outcomes will be closely monitored throughout the study duration.

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