Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

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 Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.

Official Title
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Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness

Conditions
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Corneal Endothelial Cell Loss

Intervention / Treatment
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* Device: Topcon Specular Microscope SP-1P
* Device: Konan Specular Microscope CELLCHEK XL


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; Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophies) Keratoconus; Long term 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 corneal transplant; Long term Fuch's dystrophy (and other corneal endothelial dystrophies); Keratoconus; Guttata; Diabetes mellitus type I or type II; 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; All contact lens wearers; Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye. Exclusion Criteria -Pathologic Adults (29-80 years old): Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS 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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No

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 Adults age 18-28 yrs<br>Non-Pathologic Adults age 18-28 yrs | Device: Topcon Specular Microscope SP-1P<br> <br> Device: Konan Specular Microscope CELLCHEK XL<br> <br> |
| Non-Pathologic Adults age 29-80 yrs<br>Non-Pathologic Adults age 29-80 yrs | Device: Topcon Specular Microscope SP-1P<br> <br> Device: Konan Specular Microscope CELLCHEK XL<br> <br> |
| Pathologic Adults age 29-80 yrs<br>Pathologic Adults age 29-80 yrs | Device: Topcon Specular Microscope SP-1P<br> <br> Device: Konan Specular Microscope CELLCHEK XL<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cell density |  | Single time point - 1 day | 
| Coefficient of variation of endothelial cell area |  | Single time point - 1 day | 
| Corneal endothelial cell % hexagonality |  | Single time point - 1 day | 
| Central corneal thickness |  | Single time point - 1 day |