Treatment Trials

4 Clinical Trials for Various Conditions

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COMPLETED
Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness
Description

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to evaluate any adverse events found during the clinical study.

COMPLETED
Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Description

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.

COMPLETED
Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Description

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.

COMPLETED
Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
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. The secondary objective is to evaluate any adverse events found during the clinical study.