NCT01663363已完成3 期
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
研究概览
简要总结
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or greater
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- •Uncorrected visual acuity (UCVA) of 20/40 or worse
- •Less than 0.75D difference between cycloplegic and manifest refraction sphere.
- •Demonstration of refractive stability
- •Anticipated post-operative stromal bed thickness of at least 250 microns
- •Willing and capable of returning for follow-up examinations for the duration of the study.
排除标准
- •Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- •Concurrent use of topical or systemic medications that may impair healing
- •History of any medical conditions that could affect wound healing
- •History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
- •Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
- •Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
研究组 & 干预措施
wavefront-guided LASIK
Experimental
LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
干预措施: LASIK correction of myopic refractive errors (Device)
结局指标
主要结局
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
时间窗: 6 Months
次要结局
- Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better(6 Months)
研究者
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