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

NCT ID: NCT06729723

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2024-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAT-001 Treatment Group

Using SAT-001 for 30 minutes

Group Type: EXPERIMENTAL

SAT-001

Intervention Type: 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.

Modified SAT-001 Treatment Group

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

Group Type: ACTIVE_COMPARATOR

modified SAT-001

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

mSAT-001

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

S-Alpha Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soolienah Rhiu, MD

Role: PRINCIPAL_INVESTIGATOR

Dongtan Sacred Heart Hospital

So Young Han, MD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Hallym University Dongtan Sacred heart Hospital

Hwaseong-si, , South Korea

Kangbuk Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SAT-001-KP-004

Identifier Type: -

Identifier Source: org_study_id