Clinical Trial: Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: Topcon Medical Systems, Inc.
Current Primary Outcome:
- Corneal endothelial cell density [ Time Frame: Single time point - 1 day ]
- Coefficient of variation of endothelial cell area [ Time Frame: Single time point - 1 day ]
- Corneal endothelial cell % hexagonality [ Time Frame: Single time point - 1 day ]
- Central corneal thickness [ Time Frame: Single time point - 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Topcon Medical Systems, Inc.
Dates:
Date Received: May 5, 2014
Date Started: February 2014
Date Completion:
Last Updated: April 22, 2015
Last Verified: November 2014
