Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements (NCT02138266) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
United States65 participantsStarted 2014-02
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …