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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01695629
Collaborator
(none)
37
Enrollment
1
Location
59
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    None to Mild

    Subjects with Diabetes with none to mild peripheral neuropathy
    Severe

    Subjects with diabetes with severe neuropathy

    Outcome Measures

    Primary Outcome Measures

    1. changes between control and diabetic patients [12 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Kellogg Eye Center Ann Arbor Michigan United States 48105

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roni Shtein, Assistant Professor, Department of Ophthalmology, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01695629
    Other Study ID Numbers:
    • DPN-42377
    First Posted:
    Sep 28, 2012
    Last Update Posted:
    Dec 7, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases
    Diabetic Neuropathies

    Study Results

    No Results Posted as of Dec 7, 2015