Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.

Detailed Description
-----------------
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.

Official Title
-----------------
Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.

Conditions
-----------------
Corneal Endothelial Cell Loss

Intervention / Treatment
-----------------
* Device: Specular Microscope Nidek CEM-530
* Device: Specular Microscope Konan CELLCHEK XL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-Pathologic: 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. Subjects who can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. Pathologic: 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. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions: History of post-op surgical trauma including bullous keratopathy History of corneal transplant Physical injury or trauma to the cornea Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies Keratoconus Long term PMMA contact lens use (greater than 3 years) Exclusion Criteria: Non-Pathologic: 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. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions: History of post-op surgical trauma including bullous keratopathy History of corneal transplant Physical injury or trauma to the cornea Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies Keratoconus Long term PMMA contact lens use (greater than 3 years) Pathologic: 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. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 18-28 years old Non-pathologic<br>Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL | Device: Specular Microscope Nidek CEM-530<br>* Nidek CEM-530<br>Device: Specular Microscope Konan CELLCHEK XL<br>* Konan CELLCHEK XL<br>|
| 29-80 years old Non-pathologic<br>Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL | Device: Specular Microscope Nidek CEM-530<br>* Nidek CEM-530<br>Device: Specular Microscope Konan CELLCHEK XL<br>* Konan CELLCHEK XL<br>|
| 29-80 years old pathological<br>Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL | Device: Specular Microscope Nidek CEM-530<br>* Nidek CEM-530<br>Device: Specular Microscope Konan CELLCHEK XL<br>* Konan CELLCHEK XL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center Method Corneal Endothelial Cell Density |  | single time point - 1 day | 
| Center Method Coefficient of Variation of Endothelial Cell Area | Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed | single time point - 1 day | 
| Percentage Hexagonality | Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium | single time point - 1 day |