Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial
Abstract Background Myopia is a prevailing refractive disorder and rapidly increases the risk of vision-threatening conditions. Earlier intervention is crucial to suppress myopia progression; however, the pharmacological and non-pharmacological therapies currently available have limitations. SAT-001...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-04-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-025-08717-w |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850202399473401856 |
|---|---|
| author | Hae Jung Paik Byung Joo Lee Dong Hui Lim So Young Han Eun Hye Jung Hyun Jin Shin Hyun Kyung Kim Ungsoo Samuel Kim Won Jae Kim Hee Young Choi Jihae Park Soolienah Rhiu Jihye Lee Moonjeong Kim Kyunghee Kim |
| author_facet | Hae Jung Paik Byung Joo Lee Dong Hui Lim So Young Han Eun Hye Jung Hyun Jin Shin Hyun Kyung Kim Ungsoo Samuel Kim Won Jae Kim Hee Young Choi Jihae Park Soolienah Rhiu Jihye Lee Moonjeong Kim Kyunghee Kim |
| author_sort | Hae Jung Paik |
| collection | DOAJ |
| description | Abstract Background Myopia is a prevailing refractive disorder and rapidly increases the risk of vision-threatening conditions. Earlier intervention is crucial to suppress myopia progression; however, the pharmacological and non-pharmacological therapies currently available have limitations. SAT-001 is a novel digital therapeutic software developed for myopia control and is designed to overcome the limitations of existing therapies. The present study aims to evaluate the efficacy and safety of the software as a medical device, SAT-001, for the inhibition of myopia progression and treatment in pediatric patients with myopia. Methods This clinical trial is a two-arm, prospective, randomized, open-label study with a duration of approximately 25 months, comprising a maximum of 52 weeks of participant participation. We will enroll 110 pediatric patients with myopia aged 5 to < 9 years, each with a spherical equivalent of − 0.75 D to − 5.75 D in each eye. Eligible participants will be randomly assigned in a 1:1 ratio to either the study group using SAT-001 with single-vision spectacles or the control group using single-vision spectacles alone. The change in the spherical equivalent refractive error (SER) at 48 weeks from baseline serves as the primary endpoint. The change in SER at 24 weeks and axial length at every 12 weeks from baseline will be the secondary endpoints. Each change will be assessed depending on the myopic severity. Treatment emergent adverse events will be evaluated for the safety analysis. Discussion This randomized controlled trial aims to confirm the efficacy and safety of SAT-001 in slowing pediatric myopia progression. The findings of this study could establish SAT-001 as an easily accessible, convenient, and non-invasive treatment option with minimal side effects, offering long-term myopia control from an early stage. Further research is needed to validate the effectiveness of SAT-001 for moderate to high myopia and concurrent conditions like astigmatism and to improve user engagement, diversify the program, and integrate with hospital-based treatments. Trial registration ClinicalTrials.gov: NCT06344572 ; date of registration: April 12, 2024 (retrospectively registered). |
| format | Article |
| id | doaj-art-7007dade5e0c4b2f9ce4382dd36302b9 |
| institution | OA Journals |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-7007dade5e0c4b2f9ce4382dd36302b92025-08-20T02:11:47ZengBMCTrials1745-62152025-04-0126111310.1186/s13063-025-08717-wDigital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trialHae Jung Paik0Byung Joo Lee1Dong Hui Lim2So Young Han3Eun Hye Jung4Hyun Jin Shin5Hyun Kyung Kim6Ungsoo Samuel Kim7Won Jae Kim8Hee Young Choi9Jihae Park10Soolienah Rhiu11Jihye Lee12Moonjeong Kim13Kyunghee Kim14Department of Ophthalmology, Gachon University Gil Medical CenterDepartment of Ophthalmology, Asan Medical CenterDepartment of Ophthalmology, Samsung Medical CenterDepartment of Ophthalmology, Kangbuk Samsung HospitalDepartment of Ophthalmology, Nowon Eulji Medical CenterDepartment of Ophthalmology, Konkuk University Medical CenterDepartment of Ophthalmology, HanGil Eye HospitalDepartment of Ophthalmology, Chung-Ang University Gwangmeyong HospitalDepartment of Ophthalmology, Yeungnam University Medical CenterDepartment of Ophthalmology, Pusan National University HospitalDepartment of Ophthalmology, Daegu Fatima HospitalDepartment of Ophthalmology, Hallym University Dongtan Sacred Heart HospitalS-Alpha Therapeutics, Inc.S-Alpha Therapeutics, Inc.S-Alpha Therapeutics, Inc.Abstract Background Myopia is a prevailing refractive disorder and rapidly increases the risk of vision-threatening conditions. Earlier intervention is crucial to suppress myopia progression; however, the pharmacological and non-pharmacological therapies currently available have limitations. SAT-001 is a novel digital therapeutic software developed for myopia control and is designed to overcome the limitations of existing therapies. The present study aims to evaluate the efficacy and safety of the software as a medical device, SAT-001, for the inhibition of myopia progression and treatment in pediatric patients with myopia. Methods This clinical trial is a two-arm, prospective, randomized, open-label study with a duration of approximately 25 months, comprising a maximum of 52 weeks of participant participation. We will enroll 110 pediatric patients with myopia aged 5 to < 9 years, each with a spherical equivalent of − 0.75 D to − 5.75 D in each eye. Eligible participants will be randomly assigned in a 1:1 ratio to either the study group using SAT-001 with single-vision spectacles or the control group using single-vision spectacles alone. The change in the spherical equivalent refractive error (SER) at 48 weeks from baseline serves as the primary endpoint. The change in SER at 24 weeks and axial length at every 12 weeks from baseline will be the secondary endpoints. Each change will be assessed depending on the myopic severity. Treatment emergent adverse events will be evaluated for the safety analysis. Discussion This randomized controlled trial aims to confirm the efficacy and safety of SAT-001 in slowing pediatric myopia progression. The findings of this study could establish SAT-001 as an easily accessible, convenient, and non-invasive treatment option with minimal side effects, offering long-term myopia control from an early stage. Further research is needed to validate the effectiveness of SAT-001 for moderate to high myopia and concurrent conditions like astigmatism and to improve user engagement, diversify the program, and integrate with hospital-based treatments. Trial registration ClinicalTrials.gov: NCT06344572 ; date of registration: April 12, 2024 (retrospectively registered).https://doi.org/10.1186/s13063-025-08717-wTrials guidance: pediatric myopiaDigital therapeuticsSAT-001Software as a medical device (SaMD)Randomized controlled trial (RCT) |
| spellingShingle | Hae Jung Paik Byung Joo Lee Dong Hui Lim So Young Han Eun Hye Jung Hyun Jin Shin Hyun Kyung Kim Ungsoo Samuel Kim Won Jae Kim Hee Young Choi Jihae Park Soolienah Rhiu Jihye Lee Moonjeong Kim Kyunghee Kim Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial Trials Trials guidance: pediatric myopia Digital therapeutics SAT-001 Software as a medical device (SaMD) Randomized controlled trial (RCT) |
| title | Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial |
| title_full | Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial |
| title_fullStr | Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial |
| title_full_unstemmed | Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial |
| title_short | Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial |
| title_sort | digital therapeutics approach for young children with myopia using sat 001 days study protocol for a randomized controlled trial |
| topic | Trials guidance: pediatric myopia Digital therapeutics SAT-001 Software as a medical device (SaMD) Randomized controlled trial (RCT) |
| url | https://doi.org/10.1186/s13063-025-08717-w |
| work_keys_str_mv | AT haejungpaik digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT byungjoolee digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT donghuilim digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT soyounghan digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT eunhyejung digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT hyunjinshin digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT hyunkyungkim digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT ungsoosamuelkim digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT wonjaekim digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT heeyoungchoi digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT jihaepark digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT soolienahrhiu digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT jihyelee digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT moonjeongkim digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial AT kyungheekim digitaltherapeuticsapproachforyoungchildrenwithmyopiausingsat001daysstudyprotocolforarandomizedcontrolledtrial |