NCT06234189已完成不适用
The Immediate Effect of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) on the Choroid Thickness Using Swept Source-Optical Coherence Tomography (SS-OCT) on Children.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Choroidal thickness
研究概览
简要总结
The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses versus Orthokeratology lenses (OKL) for slowing myopia progression in children aged 6-12 years. A non-inferiority randomized clinical trial. The NISDO study" (ClinicalTrials.gov Identifier NCT05134935).
- •Myopia at the time of inclusion in the NISDO study (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- •Anisometropia at the time of inclusion in the NISDO study ≤ 1.50 D cycloplegic spherical equivalent refractive error.
- •Best corrected visual acuity (inclusive) at the time of inclusion in the NISDO study: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters).
排除标准
- •Manifest or intermittent squint.
- •Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca.
- •Previous eye surgery.
- •Chronic eye disease demanding daily use of eye drops.
- •Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses).
- •Previous myopia control treatment.
结局指标
主要结局
Choroidal thickness
时间窗: During 60 minutes
Thickness is measured in um
次要结局
未报告次要终点
研究者
研究点 (2)
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