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临床试验/NCT01135719
NCT01135719已完成不适用

A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Edward E. Manche2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
137
试验地点
2
主要终点
Changes in 25 and 5% low contrast visual acuity.

研究概览

简要总结

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

详细描述

Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

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
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects age 21 and older.
  • Subjects with nearsightedness, farsightedness and/or astigmatism.

排除标准

  • Autoimmune diseases.
  • Children.
  • Women pregnant or nursing.
  • Ectatic corneal disease.
  • Previous ocular surgery.

结局指标

主要结局

Changes in 25 and 5% low contrast visual acuity.

时间窗: One year

Improvement in uncorrected visual acuity

时间窗: One year

Changes in best spectacle corrected visual acuity.

时间窗: One year

次要结局

  • Changes in higher order aberrations.(One year)
  • Topographic changes.(One year)
  • Quality of vision changes.(One year)

研究者

发起方
Edward E. Manche
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edward E. Manche

Stanford University School of Medicine

Stanford University

研究点 (2)

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