NCT01675479已完成不适用
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System
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
- 167
- 试验地点
- 9
- 主要终点
- Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
研究概览
简要总结
Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age at the time of pre-operative exam
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- •Demonstration of refractive stability
- •Anticipated post-operative stromal bed thickness of at least 250 microns
- •Willing and capable of returning for follow-up examinations for the duration of the study
排除标准
- •Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- •Concurrent use of topical or systemic medications that may impair healing
- •History of any medical conditions that could affect wound healing
- •History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
- •Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
- •Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
研究组 & 干预措施
wavefront-guided LASIK
Experimental
干预措施: LASIK correction of hyperopic refractive errors (Device)
结局指标
主要结局
Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
时间窗: 12 Months
Hypothesis: \<5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters
次要结局
- Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better(12 Months)
研究者
研究点 (9)
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