Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Completed
- Conditions
- Corneal Endothelial Cell Loss
- Registration Number
- NCT02138266
- Lead Sponsor
- Topcon Medical Systems, Inc.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Coefficient of variation of endothelial cell area Single time point - 1 day Central corneal thickness Single time point - 1 day Corneal endothelial cell density Single time point - 1 day Corneal endothelial cell % hexagonality Single time point - 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States
Andover Eye Associates🇺🇸Andover, Massachusetts, United States