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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
Hallym University Dongtan Sacred heart Hospital
Hwaseong-si, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
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.
Time frame: 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)
Time frame: 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).
Time frame: 15 minute before device use, 15(mSAT-001 group) or 30(SAT-001 group) minutes after device use
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.