In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy
1 other identifier
observational
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 7, 2015
December 1, 2015
4.9 years
September 26, 2012
December 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
changes between control and diabetic patients
12 years
Study Arms (2)
None to Mild
Subjects with Diabetes with none to mild peripheral neuropathy
Severe
Subjects with diabetes with severe neuropathy
Eligibility Criteria
Subjes\\cts with diabetes with none, mild or severe neuropathy
You may qualify if:
- diabetes
You may not qualify if:
- history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Related Publications (1)
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.
PMID: 26500330DERIVED
Biospecimen
Skin biopsy from leg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Ophthalmology
Study Record Dates
First Submitted
September 26, 2012
First Posted
September 28, 2012
Study Start
January 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 7, 2015
Record last verified: 2015-12