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Second 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 additional 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 NCT02427256
Study type Observational
Source Topcon Corporation
Contact
Status Completed
Phase
Start date February 2015
Completion date February 2015
View Details
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