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

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ClinicalTrials.gov Identifier: NCT02276638
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.

Tracking Information
First Submitted Date October 14, 2014
First Posted Date October 28, 2014
Results First Submitted Date March 25, 2016
Results First Posted Date March 11, 2019
Last Update Posted Date March 20, 2019
Study Start Date September 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2019)
  • Center Method Corneal Endothelial Cell Density [ Time Frame: single time point - 1 day ]
  • Center Method Coefficient of Variation of Endothelial Cell Area [ Time Frame: 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 [ Time Frame: single time point - 1 day ]
    Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Original Primary Outcome Measures
 (submitted: October 24, 2014)
  • Center and Corner Point Method Corneal Endothelial Cell Density [ Time Frame: single time point - 1 day ]
  • Center and Corner Point Method Coefficient of variation of endothelial cell area [ Time Frame: single time point - 1 day ]
  • Center and Corner Point Method Corneal endothelial cell % hexagonality [ Time Frame: single time point - 1 day ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ophthalmology Practice
Condition Corneal Endothelial Cell Loss
Intervention
  • Device: Specular Microscope Nidek CEM-530
    Nidek CEM-530
  • Device: Specular Microscope Konan CELLCHEK XL
    Konan CELLCHEK XL
Study Groups/Cohorts
  • 18-28 years old Non-pathologic
    Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Device: Specular Microscope Nidek CEM-530
    • Device: Specular Microscope Konan CELLCHEK XL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2016)
79
Original Estimated Enrollment
 (submitted: October 24, 2014)
80
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02276638
Other Study ID Numbers CEM-530-US-0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nidek Co. LTD.
Study Sponsor Nidek Co. LTD.
Collaborators Not Provided
Investigators
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
PRS Account Nidek Co. LTD.
Verification Date March 2019