A Comparison of Myopia Control Efficacy in Children With Orthokeratology, Defocus Incorporated Multiple Segment (DIMS) Spectacles, Defocus Incorporated Soft Contact (DISK) Lenses, and Single-vision Spectacles for 12 Months
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes of axial length for 12-month (mm)
研究概览
简要总结
The goal of this clinical trial is to learn if 3 optical interventions（DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. The main questions it aims to answer are:
Does orthokeratology slows the progressing myopia more significant than the DIMS or DISK? What medical problems do participants have when taking orthokeratology, DIMS and DISK? Researchers will compare all the 3 interventions to a placebo (SVS) to see if 3 interventions has significant difference in slow the axial length elongation as well as the refraction changes.
Participants will:
Take orthokeratology, DIMS, DISK or SVS every day for 12 months Visit the clinic once every 3 months for checkups and tests.
详细描述
orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must agree to participate in the study
- •Must have cycloplegic refraction with spherical equivalent refractive (SER)
- •- 2.00 D ~ - 5.00 D (including the boundary values)
- •Clinical diagnosis of astigmatism was ≤ 1.00D
- •Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye
- •Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month
- •Must have the front cornea curve value between 41.00D~44.00D
- •Must have axial length of the study eye between 23.00mm and 25.00mm at baseline
排除标准
- •keratitis
- •Conjunctivitis
- •Clinical diagnosis of entropion
- •Clinical diagnosis of glaucoma
- •Clinical diagnosis of retinal lesions
- •Clinical diagnosis of amblyopia
- •Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract)
- •Clinical diagnosis of optic nerve dysfunction
- •Have medical history of atropine eyedrops (including 1% high concentration , 0.05%, 0.01% or other low concentration)
- •Have history of wearing peripheral defocus spectacles
- •Have history of wearing duo-focal soft contact lenses
- •Unable to follow up
- •Investigators consider to be not eligible.
结局指标
主要结局
Changes of axial length for 12-month (mm)
时间窗: 12 months
The ocular axial length change at follow-up of 12-month from baseline with IOLmaster 500（IOLMaster 500, Carl Zeiss Meditec AG, Germany) in the unit of millimetre
次要结局
- Changes of Spherical Equivalence Refraction (D)(12 months)
- Dropout rate (%)(12 months)
- Changes of ocular axial length at follow-up of 3 months (mm)(3 months)
- Changes of ocular axial length at follow-up of 6 months (mm)(6 months)
- Changes of ocular axial length at follow-up of 9 months (mm)(9 months)
研究者
Kaikai QIU
Researcher
Fuzhou Southeast Institute of Visual Ophthalmology