Exploratory Study on the Effect of SAT-001 on Choroidal Thickness in Pediatric Myopia Patients

NCT06729723 | Completed

• 1 other identifier: SAT-001-KP-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial aims to exploratively compare and evaluate the structural changes in the eye (specifically changes in choroidal thickness) pre- and post-treatment of the investigational medical devices ('SAT-001' and 'modified SAT-001') in pediatric myopia patients, and the differences in their effects on the eye.

Conditions

Myopia

Keywords

Myopia; Choroidal thickness; SaMD

Outcome Measures

Primary Outcomes (3)

• Comparison of change in choroidal thickness from T0 to T1 (without device use) and from T1 to T2 (with device use) in Group 1

  Choroidal thickness will be measured using Optical Coherence Tomography (OCT) at five points: subfoveal, nasal, and temporal regions. The following comparisons will be made within Group 1: Change in Choroidal Thickness from Baseline (T0) to just before SAT-001 application (T1). Change in Choroidal Thickness from just before SAT-001 application (T1) to after SAT-001 application (T2). These changes will be evaluated and compared within Group 1.

  Baseline, 15 minute before device use, 15(mSAT-001 group) or 30(SAT-001 group) minutes after device use

• Comparison of change in choroidal thickness change from T0 to T1 (without device use) and from T1 to T2 (with device use) in Group 2

  Choroidal thickness will be measured using Optical Coherence Tomography (OCT) at five points: subfoveal, nasal, and temporal regions. The following comparisons will be made within Group 2: Change in Choroidal Thickness from Baseline (T0) to just before mSAT-001 application (T1). Change in Choroidal Thickness from just before mSAT-001 application (T1) to after mSAT-001 application (T2)

  Baseline, 15 minute before device use, 15(mSAT-001 group) or 30(SAT-001 group) minutes after device use

• Comparison of change in choroidal thickness from T1 to T2 between Group 1 and Group 2

  Choroidal thickness will be measured using Optical Coherence Tomography (OCT) at five points: subfoveal, nasal, and temporal regions. The following comparison will be made: Comparison of Choroidal Thickness Change from pre- (T1) to post-treatment of application (T2) between Group 1 (SAT-001) and Group 2 (mSAT-001).

  15 minute before device use, 15(mSAT-001 group) or 30(SAT-001 group) minutes after device use

Study Arms (2)

SAT-001 Treatment Group

EXPERIMENTAL

Using SAT-001 for 30 minutes

Device: SAT-001

Modified SAT-001 Treatment Group

ACTIVE COMPARATOR

using modified SAT-001, which excludes rest session from SAT-001, for 15 minutes

Device: modified SAT-001

Interventions

SAT-001 DEVICE

SAT-001 Treatment Group Participants in this group will use the SAT-001 device for 30 minutes. Before and after using the device, choroidal thickness will be measured using Optical Coherence Tomography (OCT) to assess changes in choroidal thickness.

SAT-001 Treatment Group

modified SAT-001 DEVICE

mSAT-001 Treatment Group Participants in this group will use the modified SAT-001 (mSAT-001) device for 15 minutes. Similar to the SAT-001 group, choroidal thickness will be measured using Optical Coherence Tomography (OCT) before and after device usage. This protocol will help evaluate the effect of the SAT-001 and modified device on choroidal thickness, with measurements taken before and after each usage.

Also known as: mSAT-001

Modified SAT-001 Treatment Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 12
• Meet the following refractive criteria by cycloplegic refraction
• Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in both eyes
• Astigmatism of 2.50 D or less in both eyes
• Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
• Gestational age of 38 weeks or more at birth, or birth weight of 2,500g or more
• Transparent ocular media
• Participants and their legal guardians who agree to participate in the clinical trial and are willing to provide signed informed consent after receiving and understanding the explanation of the trial description (participants under 6 years old may mark their agreement after receiving full information and understanding)

You may not qualify if:

• 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)
• Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
• History of multifocal lenses (e.g., progressive lenses), corneal refractive therapy lenses (Ortho-K, e.g., Dream lenses), rigid gas permeable (RGP) hard lenses, defocus incorporated multiple segments (DIMS) spectacle lenses (e.g., MyoSmart) within 30 days prior to Visit 2.
• History of using myopia control agents (e.g., atropine) within 30 days prior to Visit 2
• Currently participating in another clinical trial or who have participated in another clinical trial within 3 months prior to screening (Visit 1)
• Inappropriate at the discretion of the investigator due to potential ethical concerns or the possibility of affecting the clinical trial results

Sponsors & Collaborators

• S-Alpha Therapeutics, Inc.: lead

Study Sites (2)

Hallym University Dongtan Sacred heart Hospital

Hwaseong-si, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Soolienah Rhiu, MD

  Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

• So Young Han, MD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: August 19, 2024
• Primary Completion: October 28, 2024
• Study Completion: December 31, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)