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.
Study Type
OBSERVATIONAL
Enrollment
80
Andover Eye Associates
Andover, Massachusetts, United States
Corneal and Endothelial Cell Measurements
Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements
Time frame: single time point - 1 day
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