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

Completed

• Conditions: Corneal and Endothelial Cell Measurements

• Registration Number: NCT01729975
• 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 Specular Microscope CEM-530. The secondary objective is to evaluate any adverse events found during the clinical study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Study First Posted: 2012-11-21
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

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