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



Status:Completed
Conditions:Diabetic Neuropathy, Neurology
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:January 2011
End Date:December 2015

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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.

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.

Inclusion Criteria:

- diabetes

Exclusion Criteria:

- history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's
disease, or any known systemic neuropathy.
We found this trial at
1
site
Ann Arbor, Michigan 48105
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Ann Arbor, MI
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