Clinical Trials/NCT02138266

NCT02138266

Completed

N/A

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 country65 target enrollmentFebruary 2014

ConditionsCorneal Endothelial Cell Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Corneal Endothelial Cell Loss
Sponsor: Topcon Medical Systems, Inc.
Enrollment: 65
Locations: 1
Primary Endpoint: Coefficient of variation of endothelial cell area
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

September 2014

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Topcon Medical Systems, Inc.

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

Central corneal thickness

Time Frame: Single time point - 1 day

Corneal endothelial cell density

Time Frame: Single time point - 1 day

Corneal endothelial cell % hexagonality

Time Frame: Single time point - 1 day

Study Sites (1)

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