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

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.

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.

Study Overview

• Status: Completed
• Conditions: Corneal Endothelial Cell Loss
• Intervention / Treatment: Device: Specular Microscope Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL

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.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ophthalmology Practice

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
18-28 years old Non-pathologic; Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL	Device: Specular Microscope Nidek CEM-530; Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL; 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; Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL; 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; Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL; Konan CELLCHEK XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 10, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Corneal Diseases; Eye Manifestations; Corneal Endothelial Cell Loss
• Other Study ID Numbers: CEM-530-US-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No