Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness

Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, ％Hexagonality, and Central Corneal Thickness

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to evaluate any adverse events found during the clinical study.

Study Overview

• Status: Completed
• Conditions: Corneal and Endothelial Cell Measurements

• Study Type: Observational
• Enrollment (Actual): 80

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: Yes
• 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 follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.

• 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 follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date and subjects who have any of the following conditions:

  • History of Post-op surgical trauma including, Psudophakic or Aphakic blous keratopathy or glaucoma surgery
  • History of corneal transplant
  • Physical injury or trauma to the cornea
  • Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy)
  • Keratoconus
  • Long term PMMA contact lens use

Exclusion Criteria:

• Non-Pathologic subjects who have the following conditions:

  • Long term Diabetes
  • Dementia
  • Subjects who have other life threatening and/or debilitating systemic diseases
  • History of corneal transplant
  • Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
  • Keratoconus
  • Guttata
  • Diabetic retinopathy
  • History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
  • All contact lens wearers
• Pathologic subjects who have Dementia or who have other life threatening and/or debilitating systemic diseases

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
18-28 years old Non-pathologic
29-80 years old Non-Pathologic
29-80 years old pathologic corneal disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal and Endothelial Cell Measurements	Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements	single time point - 1 day

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: November 19, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CEM-530-US-001