Prospective, Interventional, Single-center Study to Evaluate the Influence of MiYOSMART iQ Spectacle Lenses With DIMS and Triple Enhanced Design Technology on Refraction Dynamics, Biometric Parameters, Peripheral Refraction and Contrast Sensitivity in Children With Myopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Axial Length
研究概览
简要总结
This prospective, single-center study aims to evaluate the efficacy and safety of MiYOSMART iQ spectacle lenses with DIMS (Defocus Incorporated Multiple Segments) and Triple Enhanced Design (TED) technology in slowing myopia progression in children aged 8-11 years.
35 children with myopia (spherical equivalent -0.5 to -6.0 D) will be prescribed MiYOSMART iQ lenses and followed for 6 months. The study will compare changes in spherical equivalent refraction and axial length against a historical control group (n=35) using ANCOVA. Secondary outcomes include measurements of peripheral refraction and contrast sensitivity at the first prescription.
The study hypothesis is that wearing MiYOSMART iQ lenses for 6 months significantly slows myopia progression compared to single-vision spectacle correction.
详细描述
Introduction and Scientific Rationale Progressive myopia in children is a global public health problem associated with an increased risk of ocular pathology in adulthood. Existing myopia control methods demonstrate efficacy, but there is a need for additional non-pharmacological, non-invasive approaches with a high safety profile and patient acceptability.
MiYOSMART iQ spectacle lenses with DIMS and Triple Enhanced Design (TED) technology represent a modern method of optical myopia control, based on the concept of peripheral myopic defocus.
The efficacy of MiYOSMART lenses has been proven in a number of studies, primarily in Asian populations. However, some physiological aspects of their effect, especially in Caucasian populations and in real-world clinical practice, require further study:
Insufficient data on the precise pattern of induced peripheral defocus when using open-field instruments.
Lack of studies on the effect of defocus segments on contrast sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-11 years (inclusive)
- •Myopia: spherical equivalent -0.5 to -6.0 D under cycloplegia
- •No previous myopia control treatment
- •Orthophoria, presence of binocular vision
排除标准
- •Corrected visual acuity < 0.8 (decimal)
- •Anisometropia > 2.0 D
- •Strabismus history or presence
- •Previous refractive or intraocular surgery
研究组 & 干预措施
MiYOSMART iQ intervention group
DIMS with Triple Enhanced Design technology
干预措施: MiYOSMART iQ spectacle lenses (Device)
Historical control group
Retrospective data from patients with single-vision spectacle correction
结局指标
主要结局
Change in Axial Length
时间窗: Baseline to 6 months
Change in axial length, measured in millimeters (mm)
Change in Spherical Equivalent Refraction
时间窗: Baseline to 6 months
Change in cycloplegic spherical equivalent refraction, measured in diopters (D)
次要结局
- Peripheral Refraction(At first prescription (Visit 2, within 3±1 weeks after baseline))
- Contrast Sensitivity(At first prescription (Visit 2, within 3±1 weeks after baseline))
- Safety - Incidence of Adverse Events(Throughout the study period, up to 6 months)