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Clinical Trials/NCT01695629
NCT01695629
Completed
Not Applicable

In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy

University of Michigan1 site in 1 country37 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
University of Michigan
Enrollment
37
Locations
1
Primary Endpoint
changes between control and diabetic patients
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal evaluation that permits non-invasive imaging of corneal structures on the cellular level. Precise anatomic characterization of corneal structures, including corneal nerves, can be rapidly performed with high resolution.

Detailed Description

Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek to develop could ultimately be used in large-scale clinical trials and in clinical practice to assess DPN severity and progression. We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically viable method to assess and quantify systemic peripheral nerve health. We emphasize that this imaging method can be used in both humans and animal models to provide quantifiable, longitudinal data on the same live individual to advance our understanding of the development and progression of DPN, and to evaluate treatment effectiveness.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roni Shtein

Assistant Professor, Department of Ophthalmology

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.

Outcomes

Primary Outcomes

changes between control and diabetic patients

Time Frame: 12 years

Study Sites (1)

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