Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
研究概览
简要总结
The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations;
- •Able to comprehend and sign an informed consent form;
- •Willing and able to complete all postoperative visits;
- •Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.
- •Intended treatment targeted for emmetropia;
- •Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pregnant or lactating, current or planned, during the course of the study;
- •Corneal disease;
- •Diagnosis of advanced glaucoma;
- •Uncontrolled diabetes;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
时间窗: Month 3
Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
次要结局
- Mean Manifest Refraction Cylinder at 3 Months(Month 3)
- Mean Uncorrected Visual Acuity (UCVA) at 3 Months(Month 3)