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

Completed

• Conditions: Corneal Endothelial Cell Loss
• Interventions: Device: Specular Microscope Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL

• Registration Number: NCT02276638
• Lead Sponsor: Nidek Co. LTD.

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-28
• Results First Submitted: 2016-03-25
• Results First Submitted QC: 2018-11-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-10
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
18-28 years old Non-pathologic	Specular Microscope Konan CELLCHEK XL	Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL
18-28 years old Non-pathologic	Specular Microscope Nidek CEM-530	Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL
29-80 years old Non-pathologic	Specular Microscope Nidek CEM-530	Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL
29-80 years old pathological	Specular Microscope Nidek CEM-530	Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL
29-80 years old Non-pathologic	Specular Microscope Konan CELLCHEK XL	Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL
29-80 years old pathological	Specular Microscope Konan CELLCHEK XL	Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States