NCT00713856已完成不适用
Comparison of Conventional and Custom With Iris Registration PRK Ablations: Assessment of Visual Function and Patient Satisfaction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The study objective is to compare the clinical outcomes using wavefront guided PRK with iris registration and conventional laser PRK using FDA-approved laser technology on the same patient.
详细描述
Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to custom wavefront guided PRK and the fellow eye treated with conventional PRK.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients deemed to be suitable candidates for bilateral PRK
排除标准
- •Patients desiring monovision correction rather than bilateral distance correction
研究组 & 干预措施
1
Active Comparator
干预措施: Custom PRK with iris registration (Procedure)
2
Active Comparator
干预措施: Conventional PRK (Procedure)
结局指标
主要结局
Visual acuity
时间窗: 6 months
次要结局
- Manifest refraction(6 months)
- Wavefront aberration value(6 months)
研究者
研究点 (1)
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