NCT01729975已完成不适用
Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, ％Hexagonality, and Central Corneal Thickness
Nidek Co. LTD.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Corneal and Endothelial Cell Measurements
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 Specular Microscope CEM-530. 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
- 是
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 follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
- •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 follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date and subjects who have any of the following conditions:
- •History of Post-op surgical trauma including, Psudophakic or Aphakic blous keratopathy or glaucoma surgery
- •History of corneal transplant
- •Physical injury or trauma to the cornea
- •Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy)
- •Keratoconus
- •Long term PMMA contact lens use
排除标准
- •Non-Pathologic subjects who have the following conditions:
- •Long term Diabetes
- •Subjects who have other life threatening and/or debilitating systemic diseases
- •History of corneal transplant
- •Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
- •Keratoconus
- •Diabetic retinopathy
- •History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
- •All contact lens wearers
- •Pathologic subjects who have Dementia or who have other life threatening and/or debilitating systemic diseases
结局指标
主要结局
Corneal and Endothelial Cell Measurements
时间窗: single time point - 1 day
Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements
次要结局
未报告次要终点
研究者
研究点 (1)
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