NCT01729975

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

Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, ％Hexagonality, and Central Corneal Thickness

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Nidek Co. LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Corneal and Endothelial Cell Measurements

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• First posted: 2012-11-21
• Last updated: 2012-11-21

Locations

1 site across 1 country: United States