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Trial record 4 of 28 for:    nerve | CIDP

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01379833
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : June 25, 2019
Dent Neurological Institute, Buffalo, NY
Fichte, Endl & Elmer Eyecare
Information provided by (Responsible Party):
Sangita Patel, State University of New York at Buffalo

Brief Summary:
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 or disease
Chronic Inflammatory Demyelinating Polyneuropathy

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Study Start Date : May 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01379833

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United States, New York
Dent Neurological Institute
Buffalo, New York, United States, 14226
Sponsors and Collaborators
State University of New York at Buffalo
Dent Neurological Institute, Buffalo, NY
Fichte, Endl & Elmer Eyecare
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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

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):
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Responsible Party: Sangita Patel, Principal Investigator, State University of New York at Buffalo Identifier: NCT01379833    
Other Study ID Numbers: OPT0120511
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Keywords provided by Sangita Patel, State University of New York at Buffalo:
Chronic Inflammatory Demyelinating Polyneuropathy
Neurotrophic corneal ulcer
Additional relevant MeSH terms:
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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