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Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality

NCT02276638 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2019-03-20

Study results available
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Summary

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.

Conditions

  • Corneal Endothelial Cell Loss

Interventions

DEVICE

Specular Microscope Nidek CEM-530

Nidek CEM-530

DEVICE

Specular Microscope Konan CELLCHEK XL

Konan CELLCHEK XL

Sponsors & Collaborators

  • Nidek Co. LTD.

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Andover Eye Associates

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276638 on ClinicalTrials.gov