Children Myopia
Conditions
Brief summary
The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia
Detailed description
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
Interventions
DEVICESAT-001(Software as Medical Device)
Using SAT-001 application for 48 weeks and wearing glasses or not
Sponsors
S-Alpha Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patient age 5 to 12 years old at the Screening Visit 2. Diagnosed with myopia as following refractive error via cycloplegic refraction(CR) 1. Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye 2. Astigmatism of 1.50 D or less in each eye 3. Anisometropia of less than 1.00 D 3. The age of birth over 38 weeks 4. Over 2500g of birth weight 5. Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit 6. Intraocular pressure 21 mmHg or less in each eye at the Screening Visit
Exclusion criteria
1. Administration of anti-muscarine drugs within 1 month before screening visit 2. Current or previous use of multi-focal lenses 3. 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 4. History of atropine use for treatment of myopia within 1 month before screening visit 5. Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit 6. History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision) 7. History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery) 8. Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD) 9. Down's syndrome or cerebral palsy 10. Participation in another clinical trial within 6 months before screening visit 11. History of growth hormone treatment within 1 month before screening visit 12. Medically clear to have abnormal range of intellectual development 13. Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease 14. 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 15. History of injections with histamine release and cholinergic effect within 30 days before screening visit 16. Incongruent to participate in this study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cycloplegic Refraction Error | Baseline, 24 weeks, 48 weeks |
| Change in axial length | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
Countries
South Korea
Outcome results
None listed