In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
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ClinicalTrials.gov Identifier: NCT01695629 |
Recruitment Status
:
Completed
First Posted
: September 28, 2012
Last Update Posted
: December 7, 2015
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Condition or disease |
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Diabetic Peripheral Neuropathy |
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.
Study Type : | Observational |
Actual Enrollment : | 37 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Group/Cohort |
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None to Mild
Subjects with Diabetes with none to mild peripheral neuropathy
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Severe
Subjects with diabetes with severe neuropathy
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- changes between control and diabetic patients [ Time Frame: 12 years ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- diabetes
Exclusion Criteria:
- history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695629
United States, Michigan | |
Kellogg Eye Center | |
Ann Arbor, Michigan, United States, 48105 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | September 28, 2012 Key Record Dates |
Last Update Posted: | December 7, 2015 |
Last Verified: | December 2015 |
Additional relevant MeSH terms:
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |