To Investigate Agreement Between the EM-3000 and the Predicate Device NonCon Robo Pachy (F&A) (CellChek XL).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)
研究概览
简要总结
The purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.
详细描述
The observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000 specular microscope and the control device is the NonCon Robo Pachy (F&A) (CellChek XL) specular microscope. Both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness.
The primary variable is the measurement of agreement between the two instruments for the four parameters described. The secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument.
Additionally, measurements of agreement will be made on the EM-3000 using automated analysis with and without touch-up.
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
- •Eyes with one of the following corneal conditions:
- •Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)
- •Exclusion Criteria
- •Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.
- •Non-Pathologic subjects who have the following conditions :
- •History of corneal transplant
- •Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
- •History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
- •Long term PMMA contact lens use longer than 5 years
- •Pathologic subjects
- •Keratoconus
排除标准
- 未提供
结局指标
主要结局
Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)
时间窗: 1 day visit per subject.
For Agreement between the two instruments, outcome measures include endothelial cell density (/mm2), coefficient of variation between the two instruments (SD x CD x 10-6, and percent hexagonality of cells in the measured visible field of view between the two instruments.
次要结局
- Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes(1 day visit per subject.)