Actively Recruiting
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Led by S-Alpha Therapeutics, Inc. · Updated on 2025-08-13
110
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to less than 9 years
- Spherical equivalent refractive error between -0.75 and less than -6.00 diopters in each eye
- Astigmatism of 1.50 diopters or less in each eye
- Anisometropia of 2.00 diopters or less
- Best corrected visual acuity of 0.2 logMAR or better in each eye at screening
- Able to use the SAT-001 device following instructions
- Child and legal guardian agree to participate and provide signed informed consent
You will not qualify if you...
- Use of atropine eye drops within 3 days prior to baseline
- Use of low dose atropine for myopia control within 1 month prior to baseline
- Use of multifocal lenses, orthokeratology, or rigid gas permeable lenses within 1 month prior to baseline
- Ocular abnormalities in cornea, lens, retina, iris, or ciliary body, or malignant tumors in orbital area
- History of eye diseases such as manifest or intermittent strabismus, amblyopia, and nystagmus (except strabismus with binocular vision)
- History of ocular surgery including eyelid, strabismus, intraocular, or refractive correction surgery (except simple double eyelid surgery)
- Diagnosis of Down's syndrome or cerebral palsy
- Participation in other clinical trials within 6 months prior to screening
- Clinically significant systemic diseases such as congenital heart disease, respiratory, endocrine, or neurological diseases
- Systemic diseases affecting vision or visual field
- Use of growth hormone treatment within 1 month prior to baseline
- Other reasons deemed by investigator as inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gachon University Gil Hospital
Incheon, South Korea
Actively Recruiting
Research Team
Y
YS Park
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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