Completed
OBSERVATIONAL
NCT02276638
Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Detailed Description
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.
Interventions
Name:
Specular Microscope Nidek CEM-530
Type:
DEVICE
Description:
Nidek CEM-530
Name:
Specular Microscope Konan CELLCHEK XL
Type:
DEVICE
Description:
Konan CELLCHEK XL
Primary Outcomes
Measure:
Center Method Corneal Endothelial Cell Density
TimeFrame:
single time point - 1 day
Description:
Measure:
Center Method Coefficient of Variation of Endothelial Cell Area
TimeFrame:
single time point - 1 day
Description:
Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed
Measure:
Percentage Hexagonality
TimeFrame:
single time point - 1 day
Description:
Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Trial Information
NCT ID
NCT02276638
Status
Completed
Study Type
OBSERVATIONAL
Sponsor
Nidek Co. LTD.
Last Updated
December 15, 2025