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

Corneal Endothelial Cell Loss Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276638
• Other study ID #: CEM-530-US-0002
• Status: Completed
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2019
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Endothelial Cell Loss

Intervention

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

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center Method Corneal Endothelial Cell Density		single time point - 1 day
Primary	Center Method Coefficient of Variation of Endothelial Cell Area	Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed	single time point - 1 day
Primary	Percentage Hexagonality	Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium	single time point - 1 day