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.
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.
Study Type
OBSERVATIONAL
Enrollment
79
Nidek CEM-530
Konan CELLCHEK XL
Andover Eye Associates
Andover, Massachusetts, United States
Center Method Corneal Endothelial Cell Density
Time frame: single time point - 1 day
Center Method Coefficient of Variation of Endothelial Cell Area
Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed
Time frame: single time point - 1 day
Percentage Hexagonality
Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Time frame: single time point - 1 day
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