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Trial record 2 of 36 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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by State University of New York at Buffalo.
Recruitment status was:  Recruiting
Dent Neurological Institute, Buffalo, NY
Fichte, Endl & Elmer Eyecare
Information provided by:
State University of New York at Buffalo Identifier:
First received: June 16, 2011
Last updated: June 21, 2011
Last verified: June 2011
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.

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
    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
    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)
Subjects are patients with CIDP
Controls are age-matched people without CIDP

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe CIDP.

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.
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Please refer to this study by its identifier: NCT01379833

Contact: Bennett Myers, M.D. 716-250-2000

United States, New York
Dent Neurological Institute Recruiting
Buffalo, New York, United States, 14226
Contact: Surbhi Bansal, M.D.    716-881-7900   
Principal Investigator: Bennett Myers, M.D.         
Sponsors and Collaborators
State University of New York at Buffalo
Dent Neurological Institute, Buffalo, NY
Fichte, Endl & Elmer Eyecare
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

1. Bonini S et al. Neurotrophic Keratitis. Contemporary Ophthalmology. 2008. 7(2): 1-8. 2. Grupcheva CH et al. Assessing the sub-basal nerve plexus of the living healthy human cornea by in vivo confocal microscopy. Clinical and Experimental Ophthalmology. 2002, 30: 187-190. 3. Malik RA et al. Corneal confocal microscopy: a non-invasive surrogate of nerve fibre damage and repair in diabetic patients. Diabetologia. 2003. 46: 683-688. 4. Merkies IS et al. Understanding the consequences of chronic inflammatory demyelinating polyradiculoneuropathy from impairments to activity and participation restrictions and reduced quality of life: the ICE study. J Peripher Nerv Syst. 2010 Sep;15(3):208-15. 5. Nobile-Orazio E et al. Chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy: treatment update. Current Opinion in Neurology. 2010; 23: 519-523. 6. Oh SJ. Color Atlas of Nerve Biopsy Pathology. 1st Edition. CRC Press LLC, Boca Raton, Florida. Copyright 2002. 7. Patel DV et al. Contemporary in vivo confocal microscopy of the living human cornea using white light and laser scanning techniques: a major review. Clinical and Experimental Ophthalmology 2007; 35: 71-88. 8. Rajabelly YA et al. Electrophysiological sensory demyelination in typical chronic inflammatory demyelinating polyneuropathy. European Journal of Neurology 2010, 17: 939-944. 9. Van den Bergh PYK et al. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - First Revision. European Journal of Neurology. 2010, 17: 356-363. 10. American Academy of Neurology.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Surbhi Bansal, M.D., Ross Eye Institute, University at Buffalo Identifier: NCT01379833     History of Changes
Other Study ID Numbers: OPT0120511
Study First Received: June 16, 2011
Last Updated: June 21, 2011

Keywords provided by State University of New York at Buffalo:
Chronic Inflammatory Demyelinating Polyneuropathy
Neurotrophic corneal ulcer

Additional relevant MeSH terms:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017