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

January 8, 2025 updated by: S-Alpha Therapeutics, Inc.

A Multicenter, Randomized, Open-label, Parallel-group, Exploratory Clinical Trial to Evaluate the Effect of the Software as a Medical Device (SaMD) SAT-001 on the Changes in Choroidal Thickness in Pediatric Myopia Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myopia is a rapidly growing global concern, particularly in pediatric populations, with high rates of progression and the potential for serious long-term consequences. The risk of developing high myopia, which can lead to complications such as retinal detachment, cataracts, glaucoma, and optic nerve abnormalities, underscores the importance of effective management strategies for pediatric myopia. While treatments to slow myopia progression have been explored, including pharmacological and non-pharmacological approaches, further investigation is needed into their long-term safety and efficacy.

This multicenter, randomized, open-label, parallel-group, exploratory clinical trial aims to evaluate the impact of SAT-001, a Software as a Medical Device (SaMD), on choroidal thickness in pediatric patients. The study will compare changes in choroidal thickness between two groups: one receiving SAT-001 and the other receiving mSAT-001, a modified version of SAT-001 that excludes the rest period during device use. Participants will be assessed before and after a single application of the device.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Hwaseong-si, Korea, Republic of
        • Hallym University Dongtan Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children aged 4 to 12

  2. Meet the following refractive criteria by cycloplegic refraction

    1. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in both eyes
    2. Astigmatism of 2.50 D or less in both eyes
  3. Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
  4. Gestational age of 38 weeks or more at birth, or birth weight of 2,500g or more
  5. Transparent ocular media
  6. 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)

Exclusion Criteria:

  1. History of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
  2. History of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery)
  3. Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
  4. 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.
  5. History of using myopia control agents (e.g., atropine) within 30 days prior to Visit 2
  6. Currently participating in another clinical trial or who have participated in another clinical trial within 3 months prior to screening (Visit 1)
  7. Inappropriate at the discretion of the investigator due to potential ethical concerns or the possibility of affecting the clinical trial results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAT-001 Treatment Group
Using SAT-001 for 30 minutes
Device: SAT-001
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.
Active Comparator: Modified SAT-001 Treatment Group
using modified SAT-001, which excludes rest session from SAT-001, for 15 minutes
Device: modified SAT-001

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.

Other Names:
  • mSAT-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of change in choroidal thickness from T0 to T1 (without device use) and from T1 to T2 (with device use) in Group 1
Time Frame: Baseline, 15 minute before device use, 15(mSAT-001 group) or 30(SAT-001 group) minutes after device use

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S-Alpha Therapeutics, Inc.

Investigators

  • Principal Investigator: Soolienah Rhiu, MD, Dongtan Sacred Heart Hospital
  • Principal Investigator: So Young Han, MD, Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2024

Primary Completion (Actual)

October 28, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAT-001-KP-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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