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

NCT02293122 | Completed

• 1 other identifier: 602-a01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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 substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.

Conditions

Cornea

Outcome Measures

Primary Outcomes (1)

• Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)

  For Agreement between the two instruments, outcome measures include endothelial cell density (/mm2), coefficient of variation between the two instruments (SD x CD x 10-6, and percent hexagonality of cells in the measured visible field of view between the two instruments.

  1 day visit per subject.

Secondary Outcomes (1)

• Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes

  1 day visit per subject.

Study Arms (1)

Observational

Observational group exposure to three test devices and one comparative device. The test Konan Non-con Robo Pachy F\&A Specular Microscope.

Other: Observational

Interventions

Observational OTHER

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.

Observational

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study plan calls for 75 subjects divided into three sub-groups, young healthy (18-50 yrs), older healthy (51-80 yrs), and pathologic adults (29-80 years).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomey Corporation: lead
• Ohio State University: collaborator
• R. P. Chiacchierini Consulting, LLC: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Melissa Bailey, OD

  Professor, College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

US (1)