Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL

Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL for the Measurements of Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness

The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.

Study Overview

• Status: Completed
• Conditions: Corneal and Endothelial Cell Measurements
• Intervention / Treatment: Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope

Detailed Description

The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium by capturing an image of corneal endothelium tissues. without making contact, analyzing the captured image, and calculating data such as cell density.

• Study Type: Observational
• Enrollment (Actual): 81

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

Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)

1. Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
3. Subjects who agree to participate in the study.

Inclusion Criteria -Pathologic adults (29-80 years old):

1. Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
3. Subjects who agree to participate in the study;

4. At least one eye with any of the following conditions:

   1. History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy
   2. History of corneal transplant
   3. Physical injury or trauma to the cornea
   4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
   5. Keratoconus
   6. Long-term polymethyl methacrylate (PMMA) contact lens use (greater than 3 years).

Exclusion Criteria - Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)

1. History of post-op surgical trauma including bullous keratopathy;
2. History of corneal transplant;
3. Evidence of physical injury or trauma to the cornea;
4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
5. Keratoconus;
6. Long-term PMMA contact lens use (greater than 3 years);
7. History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
8. Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL images in either eye.

Exclusion Criteria - Pathologic adults (29-80 years old)

1. History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
2. Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-pathologic young adults; 18-28 years old	Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope
Non-pathologic adults; 29-80 years old	Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope
Pathologic adults; 29-80 years old	Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endothelial cell density measurements	1 day
Coefficient of variation of endothelial cell area	1 day
% Hexagonality	1 day
Central Corneal Thickness	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	1 day

Collaborators and Investigators

• Sponsor: Tomey Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimated): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TOMEY-EM4000-US-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO