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Clinical Trials/NCT02427256
NCT02427256
Completed
Not Applicable

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

Topcon Medical Systems, Inc.1 site in 1 country76 target enrollmentFebruary 2015
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ConditionsCorneal Endothelial Cell Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Endothelial Cell Loss
Sponsor
Topcon Medical Systems, Inc.
Enrollment
76
Locations
1
Primary Endpoint
Coefficient of variation of endothelial cell area
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of this clinical study is to collect additional 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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
February 2015
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Corneal endothelial cell density

Time Frame: Single time point - 1 day

Study Sites (1)

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