Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality

Nidek

Status

Completed

Conditions

Corneal Endothelial Cell Loss

Treatments

Device: Specular Microscope Nidek CEM-530

Device: Specular Microscope Konan CELLCHEK XL

Study type

Observational

Funder types

Industry

Identifiers

NCT02276638

CEM-530-US-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.