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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAT-001 | Experimental |
| |
| Control Group | No Intervention | Wearing glasses or not |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAT-001(Software as Medical Device) | Device | Using SAT-001 application for 48 weeks and wearing glasses or not |
|
| Measure | Description | 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 |
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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)
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HanGil Eye Hospital | Incheon | South Korea | ||||
| Kangbuk Samsung Medical Center |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Seoul |
| South Korea |
| Konkuk University Medical Center | Seoul | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul Asan Medical Center | Seoul | South Korea |