Phase
Condition
Myopia
Treatment
SAT-001
Single vision spectacles
Clinical Study ID
Ages 5-8 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 eacheye
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 ScreeningVisit
Able to successfully accomplish SAT-001, the investigational device (able to followthe written and verbal instruction)
Subjects and their legal guardians who agree to participate in the clinical trialand are willing to provide the signed informed consent after receiving andcomprehending the explanation of the description of this clinical trial (subjectunder 6 can make a mark for agreement after full information and understanding)
Exclusion
Exclusion Criteria:
History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatmentof myopia control with low dose atropine within 1 month prior to Baseline)
Current or prior use of multifocal lenses (e.g. progressive addition lenses),orthokeratology (Ortho-K, e.g. Dream lens), or Rigid gas permeable (RGP) within 1month prior to Baseline(Visit 2)
Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., orpresence of malignant tumors in the orbital area
History of eye diseases such as manifest strabismus, intermittent strabismus,amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
History of ocular surgery such as eyelid surgery, strabismus surgery, intraocularsurgery, or refractive correction surgery (excluding simple double eyelid surgery)
Down's syndrome or cerebral palsy
Within 6 months prior to the Screening visit (Visit 1), has experience of otherclinical trial medications or investigational device
Clinically significant systemic diseases such as congenital heart disease,respiratory disease, endocrine disease, and neurological disease that theinvestigator may consider inappropriate for participation in the clinical trials
Systemic diseases that could impact both vision and visual field
History of growth hormone treatment within 1 month prior to Baseline (Visit 2)
Other reasons for participation in the trial at the discretion of the investigator
Study Design
Study Description
Connect with a study center
Gachon University Gil Hospital
Incheon,
Korea, Republic ofActive - Recruiting
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