Extension Study to Assess Long-Term Safety and Rebound Effect of SAT-001 Software for Slowing Myopia Progression in Children Aged 5 to 8

What this Trial Is About

This research focuses on children aged 5 to less than 9 years with myopia. It aims to study the rebound effect, where myopia progression may accelerate after stopping treatment, and to evaluate the long-term safety of SAT-001, a Software as a Medical Device designed to slow myopia progression in pediatric patients. This study serves as an extension to a previous trial that initially tested SAT-001s effects on myopia progression. Participants from the earlier trial, including both those who received SAT-001 plus single vision spectacles and those who only wore spectacles, will be followed for 6 months. During this extension phase, all participants continue wearing single vision spectacles but will no longer receive SAT-001 treatment. The study will monitor changes in eye measurements to assess any rebound in myopia and to observe safety outcomes after stopping SAT-001. Childrens eye health will be regularly evaluated through measurements of spherical equivalent refractive error and axial length at baseline, 12 weeks, and 24 weeks. Researchers will also observe any adverse effects related to stopping SAT-001. The total participation time in this extension study is 6 months following the completion of the initial trial, allowing for close monitoring of myopia progression and safety.

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