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

NCT ID: NCT02276638

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-10-31

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.

Conditions

Corneal Endothelial Cell Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

18-28 years old Non-pathologic

Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL

Specular Microscope Nidek CEM-530

Intervention Type: DEVICE

Nidek CEM-530

Specular Microscope Konan CELLCHEK XL

Intervention Type: DEVICE

Konan CELLCHEK XL

29-80 years old Non-pathologic

Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL

Specular Microscope Nidek CEM-530

Intervention Type: DEVICE

Nidek CEM-530

Specular Microscope Konan CELLCHEK XL

Intervention Type: DEVICE

Konan CELLCHEK XL

29-80 years old pathological

Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL

Specular Microscope Nidek CEM-530

Intervention Type: DEVICE

Nidek CEM-530

Specular Microscope Konan CELLCHEK XL

Intervention Type: DEVICE

Konan CELLCHEK XL

Interventions

Specular Microscope Nidek CEM-530

Nidek CEM-530

Intervention Type: DEVICE

Specular Microscope Konan CELLCHEK XL

Konan CELLCHEK XL

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nidek Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

CEM-530-US-0002

Identifier Type: -

Identifier Source: org_study_id