A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
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
- 是
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
Edward E. Manche
Stanford University School of Medicine
Stanford University
