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

Launched by TOPCON MEDICAL SYSTEMS, INC. · Apr 22, 2015

Keywords

ClinConnect Summary

No description provided

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, 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.