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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in Axial Length [Срок оценки: Baseline, 48weeks]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Gachon University Gil Hospital — Incheon

Публикации

• 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

Идентификаторы

NCT: NCT06344572 · SAT001-KP-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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