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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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None to Mild

Subjects with Diabetes with none to mild peripheral neuropathy

No interventions assigned to this group

Severe

Subjects with diabetes with severe neuropathy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diabetes

Exclusion Criteria

* history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Roni Shtein

Assistant Professor, Department of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kellogg Eye Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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DeMill DL, Hussain M, Pop-Busui R, Shtein RM. Ocular surface disease in patients with diabetic peripheral neuropathy. Br J Ophthalmol. 2016 Jul;100(7):924-928. doi: 10.1136/bjophthalmol-2015-307369. Epub 2015 Oct 23.

Reference Type DERIVED

PMID: 26500330 (View on PubMed)

Other Identifiers

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DPN-42377

Identifier Type: -

Identifier Source: org_study_id