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To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)

NCT02293122 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2023-08-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.

Conditions

  • Cornea

Interventions

OTHER

Observational

Intervention is observational to two different diagnostic devices for which comparative readings of the corneal endothelium are being measured; the test device- the EM-3000 Specular Microscope against the Konan Robo-pachy F\&A Specular Microscope.

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • R. P. Chiacchierini Consulting, LLC

    collaborator INDUSTRY

  • Tomey Corporation

    lead INDUSTRY

Principal Investigators

  • Melissa Bailey, OD · Professor, College of Optometry

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

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 NCT02293122 on ClinicalTrials.gov