NCT02138266已完成不适用
Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Coefficient of variation of endothelial cell area
研究概览
简要总结
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.
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 80 Years（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
Coefficient of variation of endothelial cell area
时间窗: Single time point - 1 day
Central corneal thickness
时间窗: Single time point - 1 day
Corneal endothelial cell density
时间窗: Single time point - 1 day
Corneal endothelial cell % hexagonality
时间窗: Single time point - 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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