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

Topcon

Status

Completed

Conditions

Corneal Endothelial Cell Loss

Treatments

Device: Konan Specular Microscope CELLCHEK XL

Device: Topcon Specular Microscope SP-1P

Study type

Observational

Funder types

Industry

Identifiers

NCT02427256

TOPCON-SP-1P-US-0002

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.