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Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

NCT02138266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2022-06-08

No results posted yet for this study

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.

Conditions

  • Corneal Endothelial Cell Loss

Interventions

DEVICE

Topcon Specular Microscope SP-1P

DEVICE

Konan Specular Microscope CELLCHEK XL

Sponsors & Collaborators

  • Topcon Medical Systems, Inc.

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-03-31
Completion
2014-09-30

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 NCT02138266 on ClinicalTrials.gov