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Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

Corneal Endothelial Cell Loss Clinical Trial

Official title:
Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness

Clinical Trial Summary

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02138266
Study type Observational
Source Topcon Corporation
Contact
Status Completed
Phase
Start date February 2014
Completion date September 2014
View Details
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