Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
This study is currently recruiting participants.
Verified June 2011 by State University of New York at Buffalo
Sponsor:
State University of New York at Buffalo
Collaborators:
Dent Neurological Institute, Buffalo, NY
Fichte, Endl & Elmer, Buffalo, NY
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01379833
First received: June 16, 2011
Last updated: June 21, 2011
Last verified: June 2011
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Purpose
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a demyelinating chronic progressive or relapsing neuropathy believed to be secondary to an autoimmune response against peripheral nerve antigens.5 We have observed two patients with CIDP with decreased corneal sensation who also suffered neurotrophic corneal ulcers and severe visual loss in the affected eyes. We want to explore the relationship of CIDP and corneal sensitivity. Our hypothesis is that people with CIDP have decreased corneal sensation compared to those without. We plan to perform a prospective study measuring corneal sensation in patients (proposed n=10) with CIDP and without to determine (1) if a difference exists in patients with CIDP compared to controls and (2) the magnitude of the difference. If a difference is detected in corneal sensitivity in patients with CIDP, this awareness amongst physicians and patients may help prevent blinding complications.
| Condition |
|---|
|
Chronic Inflammatory Demyelinating Polyneuropathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
Further study details as provided by State University of New York at Buffalo:
Primary Outcome Measures:
- Corneal Sensitivity [ Designated as safety issue: No ]The most important variable here is corneal sensitivity in study subjects vs. controls. This is a prospective screen to determine if a difference exists before pursuing larger studies. The endpoint for this investigation will be analysis of 10 patients with CIDP and 10 age-matched controls.
Secondary Outcome Measures:
- Corneal nerve density [ Designated as safety issue: No ]If there is a difference observed in corneal sensation between subjects and controls, then corneal nerve densities in respective corneas will be measured.
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Subjects
Subjects are patients with CIDP
|
|
Controls
Controls are age-matched people without CIDP
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with severe CIDP.
Criteria
Inclusion Criteria:
- Participants must be > 18 years of age. Patients with severe CIDP will be enrolled with age-matched controls without CIDP.
Exclusion Criteria:
- Eye disease (prior or current) other than glasses, Prior eye injury/ trauma, Viral infection (HSV/VZV - prior or current) of eye, Use of contact lenses in last month, Prior eye surgery / laser/lasik, and Use of eye drops other than artificial tears.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379833
Contacts
| Contact: Bennett Myers, M.D. | 716-250-2000 | bmyers@dentinstitute.com |
Locations
| United States, New York | |
| Dent Neurological Institute | Recruiting |
| Buffalo, New York, United States, 14226 | |
| Contact: Surbhi Bansal, M.D. 716-881-7900 sbansal@buffalo.edu | |
| Principal Investigator: Bennett Myers, M.D. | |
Sponsors and Collaborators
State University of New York at Buffalo
Dent Neurological Institute, Buffalo, NY
Fichte, Endl & Elmer, Buffalo, NY
Investigators
| Principal Investigator: | Surbhi Bansal, M.D. | Ross Eye Institute, University at Buffalo |
| Study Director: | Sangita Patel, M.D. PhD. | Ross Eye Institute, University at Buffalo |
| Study Director: | Thomas Elmer, M.D. | Fichte, Endl & Elmer |
More Information
No publications provided
| Responsible Party: | Surbhi Bansal, M.D., Ross Eye Institute, University at Buffalo |
| ClinicalTrials.gov Identifier: | NCT01379833 History of Changes |
| Other Study ID Numbers: | OPT0120511 |
| Study First Received: | June 16, 2011 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by State University of New York at Buffalo:
|
Chronic Inflammatory Demyelinating Polyneuropathy Neurotrophic corneal ulcer |
Additional relevant MeSH terms:
|
Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013