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.

Vejle Hospital1 个研究点分布在 1 个国家目标入组 90 人2022年6月29日

适应症Myopia

干预措施Orthokerathology lenses (OKL)Defocus Incorporated Multiple Segment (DIMS) Spectacles

概览

阶段: 不适用
干预措施: Orthokerathology lenses (OKL)
疾病 / 适应症: Myopia
发起方: Vejle Hospital
入组人数: 90
试验地点: 1
主要终点: Axial length growth of the eye
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2022年6月29日

结束日期

2025年12月2日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Vejle Hospital

责任方

Sponsor

入排标准

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.