NCT00366574已完成不适用
Comparison of INTRALASE® to AMADEUS™ Microkeratome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.
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
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
- •Candidate for bilateral wavefront-guided LASIK
- •Myopia up to -7.00 D
- •Astigmatism of 0.00 to -1.50 D
排除标准
- •History of ocular pathology
- •Previous ocular surgery
- •Very large pupils (greater than 8mm diameter, infrared measurement)
- •Thin corneas (preoperatively calculated minimal residual bed < 250 um)
- •Irregular astigmatism
- •Asymmetric astigmatism
- •Unstable refraction
- •Any other criteria that precludes subject to undergo LASIK
结局指标
主要结局
Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation
次要结局
未报告次要终点
研究者
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