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

NCT ID: NCT01729975

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Brief Summary

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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

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Conditions

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Corneal and Endothelial Cell Measurements

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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18-28 years old Non-pathologic

No interventions assigned to this group

29-80 years old Non-Pathologic

No interventions assigned to this group

29-80 years old pathologic corneal disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nidek Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CEM-530-US-001

Identifier Type: -

Identifier Source: org_study_id