Status:
COMPLETED
To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)
Lead Sponsor:
Tomey Corporation
Collaborating Sponsors:
Ohio State University
R. P. Chiacchierini Consulting, LLC
Conditions:
Cornea
Eligibility:
All Genders
18-80 years
Brief 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...
Detailed Description
The observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000 specular microscope and t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Eyes with one of the following corneal conditions:
- Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)
- Exclusion Criteria
- Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.
- Non-Pathologic subjects who have the following conditions :
- History of corneal transplant
- Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
- Guttata
- History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
- Long term PMMA contact lens use longer than 5 years
- Pathologic subjects
- Keratoconus
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02293122
Start Date
November 1 2014
End Date
July 1 2015
Last Update
August 22 2023
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210