MyopiaNCT06729723

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

A study testing SAT-001 and modified SAT-001 in people with Myopia, run by S-Alpha Therapeutics, Inc. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 4 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: SAT-001 and modified SAT-001
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesSouth Korea
Study dates: 19 Aug 2024to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children aged 4 to 12
Meet the following refractive criteria by cycloplegic refraction
Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in both eyes
Astigmatism of 2.50 D or less in both eyes
Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
Gestational age of 38 weeks or more at birth, or birth weight of 2,500g or more
Transparent ocular media
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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Hallym University Dongtan Sacred heart Hospital
Hwaseong-si
Kangbuk Samsung Medical Center
Seoul

Other trials in South Korea

About this study

Official title: 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

Read the 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
Being tested: SAT-001, modified SAT-001
Keywords: Myopia, Choroidal thickness, SaMD
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAT-001Device
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-001Device
Also called mSAT-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.

Study groups in NCT06729723
Study group	Role	What they receive
SAT-001 Treatment Group	Experimental	Using SAT-001 for 30 minutes Receives: Device: SAT-001
Modified SAT-001 Treatment Group	Active comparator	using modified SAT-001, which excludes rest session from SAT-001, for 15 minutes Receives: Device: modified SAT-001

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202431 Dec 2024

First posted11 Dec 2024
Study start19 Aug 2024
Primary completion28 Oct 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06729723
Sponsor's protocol ID: SAT-001-KP-004
Status last verified: Jan 2025
First submitted: 4 Dec 2024
Last updated: 10 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06729723
Acronym / sponsor ID: SAT-001-KP-004
Conditions: Myopia
Keywords: Myopia, Choroidal thickness, SaMD
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: S-Alpha Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Aug 2024 (actual)
Primary completion: 28 Oct 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 11 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SAT-001 Treatment Group	Experimental	Device: SAT-001Using SAT-001 for 30 minutes
Modified SAT-001 Treatment Group	Active comparator	Device: modified SAT-001using modified SAT-001, which excludes rest session from SAT-001, for 15 minutes

Who may qualify

Ages: 4 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Children aged 4 to 12
Meet the following refractive criteria by cycloplegic refraction
Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
Gestational age of 38 weeks or more at birth, or birth weight of 2,500g or more
Transparent ocular media

Key exclusion criteria (7 listed)

History of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
History of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery)
Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
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.
History of using myopia control agents (e.g., atropine) within 30 days prior to Visit 2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SAT-001SAT-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	SAT-001 Treatment Group
modified SAT-001Also: mSAT-001mSAT-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.	Device	Modified SAT-001 Treatment Group

Primary outcome

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.
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)
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Soolienah Rhiu, MD principal investigator

Dongtan Sacred Heart Hospital

So Young Han, MD principal investigator

Kangbuk Samsung Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SAT-001 and modified SAT-001 in people with Myopia, run by S-Alpha Therapeutics, Inc. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06729723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.