Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia

Myopic pediatric prevalence rate come to increase rapidly globally. This is a clinical trial to explore the safety and effectiveness of SAT-001(as a Software as Medical Device) developed for the treatment of myopia through suppressing the progress myopia

Inclusion criteria

• Pediatric patient age 5 to 12 years old at the Screening Visit
• Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)

• Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye
• Astigmatism of 1.50 D or less in each eye
• Anisometropia of less than 1.00 D
• The age of birth over 38 weeks
• Over 2500g of birth weight
• Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
• Intraocular pressure 21 mmHg or less in each eye at the Screening Visit

Exclusion criteria

• Administration of anti-muscarine drugs within 1 month before screening visit
• Current or previous use of multi-focal lenses
• Planning to use or having used Orthokeratology lenses (Ortho-K lenses), Rigid Gas Permeable (RGP) lenses, and other contact lenses to reduce the progression of myopia
• History of atropine use for treatment of myopia within 1 month before screening visit
• Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit
• History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision)
• History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery)
• Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD)
• Down's syndrome or cerebral palsy
• Participation in another clinical trial within 6 months before screening visit
• History of growth hormone treatment within 1 month before screening visit
• Medically clear to have abnormal range of intellectual development
• Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease
• Currently taking or having taken antihistamines (tablets, nasal spray, eye drops, etc.) or psychiatric drugs (antidepressants, anti-anxiety medications, etc.) within 30 days before screening visit
• History of injections with histamine release and cholinergic effect within 30 days before screening visit
• Incongruent to participate in this study at the discretion of the investigator