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

NCT06729723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-10

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • S-Alpha Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Soolienah Rhiu, MD · Dongtan Sacred Heart Hospital

  • So Young Han, MD · Kangbuk Samsung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2024-10-28
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729723 on ClinicalTrials.gov