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临床试验/NCT04486976
NCT04486976已完成不适用

Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software

Tomey Corporation2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2020年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

研究概览

简要总结

This study is a prospective comparative, randomized, single center study to gather agreement and precision data in all subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Angle-Opening Distance Angle-Opening Distance

Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Thickness of Cornea

Agreement of OCT image quality for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT and evaluation of visibility of predefined anatomical structures

时间窗: Up to 30 days

Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Corneal thickness

Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Angle-Opening Distance

Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Ks (steep meridian)

Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Trabecular-Iris Space Area

Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Anterior Corneal Depth

Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Pupil Diameter

Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Average Keratometry

Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Angle Recess Area

Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Kf (flat meridian)

Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Anterior Corneal Width

Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Trabecular-Iris Angle

Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Trabecular-Iris Space Area

Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

时间窗: Up to 30 days

Corneal Cylinder

次要结局

  • Adverse Events(Up to 30 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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