NCT06729723

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: S-Alpha Therapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Myopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-19
• Primary completion: 2024-10-28
• Completion: 2024-12-31
• First posted: 2024-12-11
• Last updated: 2025-01-10

Locations

2 sites across 1 country: South Korea