Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Objective refraction
研究概览
简要总结
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism < 1.50D, and anisometropia < 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-13 years
- •Caucasian ethnicity
- •Monocular/binocular decimal visual acuity with correction ≥ 1.00
- •Spherical equivalent between -0.75D and -5.00D
- •Astigmatism < 1.50D
- •Anisometropia < 1.00D
- •Evolution of at least -0.50D in one year
排除标准
- •Presence of ocular pathology or a history of ocular and systemic abnormalities
- •Strabismus or binocular vision problems
- •History of eye surgery
- •Having previously used some method to control myopia.
- •Having contraindications for the application of drugs for cycloplegia/corneal anesthesia
结局指标
主要结局
Objective refraction
时间窗: 2 years
Objective refraction will be taken after cycloplegia as the mean of 3 measurements with the i.profiler (Carl Zeiss Meditec AG, Jena, Germany) autorefractometer. The mean annual progression of the objective refraction will be compared between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens.
次要结局
- Axial length(2 years)