NCT05484531Unknown不适用
A Multicentre, Prospective, Registry Study for Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) Procedure in Myopia and Astigmatism
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
研究概览
简要总结
Multicenter, prospective, single-arm, observational, non-interventional post market clinical investigation (registry study) with the overall objective to assess safety and performance of CLEAR in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better
时间窗: 12 months post surgery
Uncorrected Distance Visual Accuity assessment
次要结局
- Refractive target [D](Preoperative assessment)
- Corrected distance visual accuity (CDVA)(12 months post surgery)
- Refraction [SphD, CylD, Axis](12 months post surgery)
- Assessment of changes in corneal topography [um](Baseline and 12 months)
- Assessment of changes in corneal pachymetry [um](Baseline and 12 months)
- Assessment of changes in "white to white" [mm](Baseline and 12 months)
- Number of Adverse Events observed in the study(Up to 12 months)
研究者
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