NCT01680354撤回不适用
Comparative Study of Surgical Laser Correction of Astigmatism
Aarhus University Hospital2 个研究点 分布在 1 个国家开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.
During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.
In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopic astigmatism between -2.0 and -5.0 diopters
- •Maximal difference in spherical equivalent refraction of 2 D between eyes
- •No ocular or systemic disease
- •Not pregnant or breastfeeding
- •Minimum BSCVA of 0.8 (decimal)
- •Normal corneal topography
- •Sufficient corneal thickness to allow the treatment
排除标准
- •Subjects not fulfilling the above criteria
结局指标
主要结局
Visual acuity
时间窗: 1 year
次要结局
- Refraction(1 year)
研究者
Anders Ivarsen
MD, PhD
Aarhus University Hospital
研究点 (2)
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