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

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

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.

Study Overview

• Status: Completed
• Conditions: Cornea
• Intervention / Treatment: Other: Observational

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 the control device is the NonCon Robo Pachy (F&A) (CellChek XL) specular microscope. Both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness.

The primary variable is the measurement of agreement between the two instruments for the four parameters described. The secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument.

Additionally, measurements of agreement will be made on the EM-3000 using automated analysis with and without touch-up.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

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

1. 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 :
2. History of corneal transplant
3. Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
4. Guttata
5. History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device

6. Long term PMMA contact lens use longer than 5 years

   -Pathologic subjects

7. Keratoconus

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes	To investigate repeatability (intra-investigator) in the EM-3000 specular microscope in the four outcome measures of the corneal endothelium as well as corneal thickness. To investigate reproducibility (inter-investigator/instrument) of the EM-3000 specular microscope in the four outcome measures of the corneal endothelium and corneal thickness.	1 day visit per subject.

Collaborators and Investigators

• Sponsor: Tomey Corporation
• Collaborators: Ohio State University; R.P. Chiacchierini & Associates.
• Investigators: Principal Investigator: Melissa Bailey, OD, Professor, College of Optometry

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimated): November 18, 2014

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Reproducibility; Repeatability; Agreement
• Other Study ID Numbers: 602-a01