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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Michigan
Information provided by (Responsible Party):
Roni Shtein, University of Michigan Identifier:
First received: September 26, 2012
Last updated: December 4, 2014
Last verified: December 2014

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 University of Michigan:

Primary Outcome Measures:
  • changes between control and diabetic patients [ Time Frame: 12 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Skin biopsy from leg

Estimated Enrollment: 45
Study Start Date: January 2011
Estimated Primary Completion Date: December 2016 (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 and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01695629

Contact: Munira Hussain, MS 734-647-8397

United States, Michigan
Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Munira Hussain, MS    734-647-8397   
Principal Investigator: Roni Shtein, MD, MS         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

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 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases processed this record on March 26, 2015