In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
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 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
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695629
|Contact: Munira Hussain, MSfirstname.lastname@example.org|
|United States, Michigan|
|Kellogg Eye Center||Recruiting|
|Ann Arbor, Michigan, United States, 48105|
|Contact: Munira Hussain, MS 734-647-8397 email@example.com|
|Principal Investigator: Roni Shtein, MD, MS|