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Recruiting NCT06344572

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

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAT-001, Single vision spectacles.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 5 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Open-label, Controlled Pivotal Study to Evaluate the Efficacy and Safety of Software SAT-001 in Slowing Myopia Progression and Treatment in Pediatric Patients With Myopia

Overview

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.

Detailed description

Myopia is a common refractive error affecting approximately 30 % of the global population, with even higher prevalence in Asian countries including Korea. This study is a confirmatory clinical trial designed to evaluate the efficacy and safety of SAT-001 for slowing the progression of myopia in children, based on the results of the exploratory clinical trial.

Interventions

  • Device SAT-001
    Device: SAT-001(a Software as Medical Device) Using SAT-001 application for 48 weeks and wearing single vision spectacles
  • Other Single vision spectacles
    Wearing single vision spectacles

Primary outcome measures

  • Change in Axial Length [Time frame: Baseline, 48weeks]
Secondary outcome measures (4)
  • Change in Axial Length [Time frame: Baseline, 12weeks, 24weeks, 36weeks]
  • Change in cycloplegic Spherical Equivalent Refractive Error [Time frame: Baseline, 24weeks, 48weeks]
  • Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia) [Time frame: Baseline, 24 weeks, 48 weeks]
  • Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia) [Time frame: Baseline, 12weeks, 24weeks, 36weeks, 48weeks]

Eligibility criteria

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 each eye
  • 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 Screening Visit
  • Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
  • Subjects and their legal guardians who agree to participate in the clinical trial and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

Exclusion criteria

  • History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatment of 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., or presence 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, intraocular surgery, 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 other clinical trial medications or investigational device
  • Clinically significant systemic diseases such as congenital heart disease, respiratory disease, endocrine disease, and neurological disease that the investigator 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Gachon University Gil Hospital — Incheon

Publications

  • Paik HJ, Lee BJ, Lim DH, Han SY, Jung EH, Shin HJ, Kim HK, Kim US, Kim WJ, Choi HY, Park J, Rhiu S, Lee J, Kim M, Kim K. Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial. Trials. 2025 Apr 8;26(1):128. doi: 10.1186/s13063-025-08717-w. PMID 40200346

Identifiers

NCT: NCT06344572 · SAT001-KP-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗