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 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 (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.