Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

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

The primary objective of this clinical study is to collect additional 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.

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, 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;
• Long term 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 quality SP-1P and CELLCHEK PLUS 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 good quality SP-1P and CELLCHEK PLUS in either eye.