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

Cornea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293122
• Other study ID #: 602-a01
• Status: Completed
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2023
• Source: Tomey Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cornea

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Tomey Corporation	Ohio State University, R.P. Chiacchierini & Associates.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.