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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Roni Shtein, University of Michigan

ClinicalTrials.gov Identifier:

NCT01695629

First received: September 26, 2012

Last updated: December 3, 2015

Last verified: December 2015

History of Changes

Purpose

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.

Condition
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:

MedlinePlus related topics: Peripheral Nerve Disorders

U.S. FDA Resources

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


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)

Groups/Cohorts
None to Mild Subjects with Diabetes with none to mild peripheral neuropathy
Severe 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.

Eligibility


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
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

Criteria

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 ClinicalTrials.gov identifier: NCT01695629

Locations


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
ClinicalTrials.gov Identifier:	NCT01695629 History of Changes
Other Study ID Numbers:	DPN-42377
Study First Received:	September 26, 2012
Last Updated:	December 3, 2015
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases	Diabetes Complications Diabetes Mellitus Endocrine System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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