Fig. 2

Scheme of the study. Figure 2 illustrates the outline of this clinical trial. The timeline is divided into several key phases: Screening visit (M-1 ~): participants will be screened for eligibility based on inclusion and exclusion criteria. ICF will be obtained from participants and their parents. Baseline assessments (D 0): eligible participants will be randomly allocated to either study group or control group. Initial measurements including medical history, physical examinations, and ophthalmic examinations will be conducted. Intervention period (weeks 0–48): participants will receive the assigned intervention. The study group will use SAT-001 and single vision spectacles, while the control group will use single vision spectacles only. Visit 3 will be conducted via phone call, with all other visits taking place at the institution. Each visit is depicted with a corresponding time frame, highlighting the sequence of events and the overall duration of the trial