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

This study has been completed.
Information provided by (Responsible Party):
Roni Shtein, University of Michigan Identifier:
First received: September 26, 2012
Last updated: December 3, 2015
Last verified: December 2015
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.

Diabetic Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy

Resource links provided by NLM:

Further study details as provided by Roni Shtein, University of Michigan:

Primary Outcome Measures:
  • changes between control and diabetic patients [ Time Frame: 12 years ]

Biospecimen Retention:   Samples Without DNA
Skin biopsy from leg

Enrollment: 37
Study Start Date: January 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
None to Mild
Subjects with Diabetes with none to mild peripheral neuropathy
Subjects with diabetes with severe neuropathy

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.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjes\cts with diabetes with none, mild or severe neuropathy

Inclusion Criteria:

  • diabetes

Exclusion Criteria:

  • history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01695629

United States, Michigan
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Roni Shtein, Assistant Professor, Department of Ophthalmology, University of Michigan Identifier: NCT01695629     History of Changes
Other Study ID Numbers: DPN-42377
Study First Received: September 26, 2012
Last Updated: December 3, 2015

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on September 19, 2017