Andover Eye Associates
Andover, Massachusetts, 01810, United States
NCT Number: NCT01729975
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Andover, Massachusetts, 01810, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: single time point - 1 day
Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements
Nidek Co. LTD.
Industry
Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, %Hexagonality, and Central Corneal Thickness
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02977793
Corneal and Endothelial Cell Measurements
View Trial Details