A Multicenter, Randomized, Open-label, Controlled Pivotal Study to Evaluate the Efficacy and Safety of Software SAT-001 in Slowing Myopia Progression and Treatment in Pediatric Patients With Myopia
The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.
• Children aged 5 to less than 9
• Meet the following refractive criteria by cycloplegic refraction
‣ Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
⁃ Astigmatism of 1.50 D or less in each eye
⁃ Anisometropia of 2.00 D or less
• Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
• Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
• Subjects and their legal guardians who agree to participate in the clinical trial 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)