Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness

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

Official Title
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Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, ％Hexagonality, and Central Corneal Thickness

Conditions
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Corneal and Endothelial Cell Measurements

Participation Criteria
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Eligibility Criteria
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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 follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date. 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 follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date and subjects who have any of the following conditions: History of Post-op surgical trauma including, Psudophakic or Aphakic blous keratopathy or glaucoma surgery History of corneal transplant Physical injury or trauma to the cornea Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy) Keratoconus Long term PMMA contact lens use Exclusion Criteria: Non-Pathologic subjects who have the following conditions: Long term Diabetes Dementia Subjects who have other life threatening and/or debilitating systemic diseases History of corneal transplant Long term Fuch's dystrophy (and other corneal endothelial dystrophy) Keratoconus Guttata Diabetic retinopathy History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. All contact lens wearers Pathologic subjects who have Dementia or who have other life threatening and/or debilitating systemic diseases

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 |
| --- | --- |
| 18-28 years old Non-pathologic<br> | |
| 29-80 years old Non-Pathologic<br> | |
| 29-80 years old pathologic corneal disease<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal and Endothelial Cell Measurements | Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements | single time point - 1 day |