Expired Study
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Andover, Massachusetts 01810


Purpose:

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.


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.


NCT ID:

NCT02427256


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Andover, Massachusetts 01810
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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