Trial record 2 of 21 for:    "Chronic inflammatory demyelinating polyneuropathy"

Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by State University of New York at Buffalo.
Recruitment status was  Recruiting
Sponsor:
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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by State University of New York at Buffalo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 29, 2014