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

NCT02276638 | Completed Results

• 1 other identifier: CEM-530-US-0002
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Endothelial Cell Loss

Outcome Measures

Primary Outcomes (3)

• Center Method Corneal Endothelial Cell Density

  single time point - 1 day

• 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

• Percentage Hexagonality

  Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium

  single time point - 1 day

Study Arms (3)

18-28 years old Non-pathologic

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

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

29-80 years old Non-pathologic

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

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

29-80 years old pathological

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

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

Interventions

Specular Microscope Nidek CEM-530 DEVICE

Nidek CEM-530

18-28 years old Non-pathologic; 29-80 years old Non-pathologic; 29-80 years old pathological

Specular Microscope Konan CELLCHEK XL DEVICE

Konan CELLCHEK XL

18-28 years old Non-pathologic; 29-80 years old Non-pathologic; 29-80 years old pathological

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ophthalmology Practice

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nidek Co. LTD.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Head, Regulatory Affairs
• Organization: Nidek

support@nidek.com

(800) 223-9044

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 28, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 20, 2019
• Results First Posted: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)