Paik Hae Jung, Lee Byung Joo, Lim Dong Hui, Han So Young, Jung Eun Hye, Shin Hyun Jin, Kim Hyun Kyung, Kim Ungsoo Samuel, Kim Won Jae, Choi Hee Young, Park Jihae, Rhiu Soolienah, Lee Jihye, Kim Moonjeong, Kim Kyunghee
Department of Ophthalmology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Department of Ophthalmology, Asan Medical Center, Seoul, Republic of Korea.
Trials. 2025 Apr 8;26(1):128. doi: 10.1186/s13063-025-08717-w.
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.
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.
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.
ClinicalTrials.gov: NCT06344572 ; date of registration: April 12, 2024 (retrospectively registered).
近视是一种常见的屈光不正疾病，会迅速增加视力威胁性疾病的风险。早期干预对于抑制近视进展至关重要；然而，目前可用的药物和非药物疗法都有局限性。SAT - 001是一款专为控制近视而开发的新型数字治疗软件，旨在克服现有疗法的局限性。本研究旨在评估作为医疗器械的SAT - 001软件对抑制近视进展以及治疗小儿近视患者的疗效和安全性。
本临床试验为双臂、前瞻性、随机、开放标签研究，为期约25个月，参与者最长参与52周。我们将招募110名5至9岁的小儿近视患者，每只眼睛的等效球镜度数为-0.75 D至-5.75 D。符合条件的参与者将按1:1的比例随机分配到使用SAT - 001和单光眼镜的研究组或仅使用单光眼镜的对照组。从基线起48周时等效球镜屈光不正（SER）的变化作为主要终点。从基线起24周时SER的变化以及每12周时眼轴长度的变化将作为次要终点。每次变化将根据近视严重程度进行评估。将评估治疗期间出现的不良事件以进行安全性分析。
这项随机对照试验旨在确认SAT - 001在减缓小儿近视进展方面的疗效和安全性。本研究结果可将SAT - 001确立为一种易于获取、方便且无创的治疗选择，副作用极小，能从早期提供长期的近视控制。需要进一步研究来验证SAT - 001对中度至高度近视以及散光等并发情况的有效性，并提高用户参与度、使程序多样化以及与医院治疗相结合。
ClinicalTrials.gov：NCT06344572；注册日期：2024年4月12日（追溯注册）
Zotero 插件
