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

NCT01729975 | Completed

• 1 other identifier: CEM-530-US-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal and Endothelial Cell Measurements

Outcome Measures

Primary Outcomes (1)

• Corneal and Endothelial Cell Measurements

  Substantial equivalence to a predicate device with respect to corneal and endothelial cell measurements

  single time point - 1 day

Study Arms (3)

18-28 years old Non-pathologic

29-80 years old Non-Pathologic

29-80 years old pathologic corneal disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ophthalmology Practice

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nidek Co. LTD.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 21, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

US (1)