NCT05134935已完成不适用
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.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Axial length growth of the eye
研究概览
简要总结
The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is:
- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?
The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- •Myopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
- •Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error.
- •Best corrected visual acuity at age 6 to 12 years (inclusive): 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.
研究组 & 干预措施
OKL
Active Comparator
干预措施: Orthokerathology lenses (OKL) (Device)
DIMS
Experimental
干预措施: Defocus Incorporated Multiple Segment (DIMS) Spectacles (Device)
结局指标
主要结局
Axial length growth of the eye
时间窗: 18 months
Length in mm is measured 18 months after therapy
次要结局
- Overall eye length growth, defined as the sum of axial length and choroidal thickness(18 months)
研究者
研究点 (1)
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