Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Center Method Corneal Endothelial Cell Density
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 Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.
详细描述
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.
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
- •Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study.
- •Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:
- •History of post-op surgical trauma including bullous keratopathy
- •History of corneal transplant
- •Physical injury or trauma to the cornea
- •Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
- •Keratoconus
- •Long term PMMA contact lens use (greater than 3 years)
排除标准
- •Non-Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:
- •History of post-op surgical trauma including bullous keratopathy
- •History of corneal transplant
- •Physical injury or trauma to the cornea
- •Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
- •Keratoconus
- •Long term PMMA contact lens use (greater than 3 years)
- •Pathologic: History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.
结局指标
主要结局
Center Method Corneal Endothelial Cell Density
时间窗: single time point - 1 day
Center Method Coefficient of Variation of Endothelial Cell Area
时间窗: single time point - 1 day
Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed
Percentage Hexagonality
时间窗: single time point - 1 day
Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
次要结局
未报告次要终点