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

• 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: Nidek Co. LTD.
• 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 ]

• 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

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

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