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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Corneal and Endothelial Cell Measurements

Intervention / Treatment
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* Device: Tomey EM-4000 Specular Microscope
* Device: Konan CellChek XL Specular Microscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old) 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. Inclusion Criteria -Pathologic adults (29-80 years old): 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 pseudophakic or aphakic bullous keratopathy History of corneal transplant Physical injury or trauma to the cornea Fuch's dystrophy, Guttata or other corneal endothelial dystrophies Keratoconus 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) History of post-op surgical trauma including bullous keratopathy; History of corneal transplant; Evidence of physical injury or trauma to the cornea; Fuch's dystrophy, Guttata or other corneal endothelial dystrophies; Keratoconus; Long-term PMMA contact lens use (greater than 3 years); 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 good Tomey EM-4000 and Konan CellChek XL images in either eye. Exclusion Criteria - Pathologic adults (29-80 years old) 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 Tomey EM-4000 and Konan CellChek XL images in either eye.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-pathologic young adults<br>18-28 years old | Device: Tomey EM-4000 Specular Microscope<br> <br> Device: Konan CellChek XL Specular Microscope<br> <br> |
| Non-pathologic adults<br>29-80 years old | Device: Tomey EM-4000 Specular Microscope<br> <br> Device: Konan CellChek XL Specular Microscope<br> <br> |
| Pathologic adults<br>29-80 years old | Device: Tomey EM-4000 Specular Microscope<br> <br> Device: Konan CellChek XL Specular Microscope<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 1 day |