NCT02138266

Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Topcon Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Corneal Endothelial Cell Loss

Interventions

Type	Name	Description
DEVICE	Topcon Specular Microscope SP-1P
DEVICE	Konan Specular Microscope CELLCHEK XL

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2014-09-01
• First posted: 2014-05-14
• Last updated: 2022-06-08

Locations

1 site across 1 country: United States