In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
| 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 and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01695629
| Contact: Munira Hussain, MS | 734-647-8397 | hussain@umich.edu |
| United States, Michigan | |
| Kellogg Eye Center | Recruiting |
| Ann Arbor, Michigan, United States, 48105 | |
| Contact: Munira Hussain, MS 734-647-8397 hussian@umich.edu | |
| Principal Investigator: Roni Shtein, MD, MS | |
More Information
No publications provided
| 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 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 |
ClinicalTrials.gov processed this record on March 03, 2015