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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.

Study Description
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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.

Condition or disease Intervention/treatment
Corneal Endothelial Cell Loss 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 Design
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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Center Method Corneal Endothelial Cell Density [ Time Frame: single time point - 1 day ]
  2. 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

  3. Percentage Hexagonality [ Time Frame: single time point - 1 day ]
    Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ophthalmology Practice
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276638


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Nidek Co. LTD.
Investigators
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Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
More Information
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Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT02276638    
Other Study ID Numbers: CEM-530-US-0002
First Posted: October 28, 2014    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Corneal Endothelial Cell Loss
Corneal Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes