Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

Launched by TOPCON MEDICAL SYSTEMS, INC. · May 12, 2014

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.