Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.

Nidek Co. LTD.1 site in 1 country79 target enrollmentSeptember 2014

ConditionsCorneal Endothelial Cell Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Corneal Endothelial Cell Loss
Sponsor: Nidek Co. LTD.
Enrollment: 79
Locations: 1
Primary Endpoint: Center Method Corneal Endothelial Cell Density
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.

Detailed Description

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

October 2014

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nidek Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-Pathologic: 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.
•Pathologic: 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 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 PMMA contact lens use (greater than 3 years)

Exclusion Criteria

•Non-Pathologic: 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 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 PMMA contact lens use (greater than 3 years)
•Pathologic: 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 at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.