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

Completed

• Conditions: Cornea
• Interventions: Other: Observational

• Registration Number: NCT02293122
• Lead Sponsor: Tomey Corporation

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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)	1 day visit per subject.	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.

Secondary Outcome Measures

Name	Time	Method
Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes	1 day visit per subject.	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.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States