Clinical Trial: Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cel
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 Summary:
Sponsor: Nidek Co. LTD.
Current Primary Outcome:
- Center and Corner Point Method Corneal Endothelial Cell Density [ Time Frame: single time point - 1 day ]
- Center and Corner Point Method Coefficient of variation of endothelial cell area [ Time Frame: single time point - 1 day ]
- Center and Corner Point Method Corneal endothelial cell % hexagonality [ Time Frame: single time point - 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Nidek Co. LTD.
Dates:
Date Received: October 14, 2014
Date Started: September 2014
Date Completion:
Last Updated: March 22, 2016
Last Verified: March 2016
