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

NCT01379833 | Completed

• 1 other identifier: OPT0120511
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Chronic Inflammatory Demyelinating Polyneuropathy; Neurotrophic corneal ulcer

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Corneal nerve density

Study Arms (2)

Subjects

Subjects are patients with CIDP

Controls

Controls are age-matched people without CIDP

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe CIDP.

You may qualify if:

• Participants must be \> 18 years of age. Patients with severe CIDP will be enrolled with age-matched controls without CIDP.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Dent Neurological Institute, Buffalo, NY: collaborator
• Fichte, Endl & Elmer Eyecare: collaborator

Study Sites (1)

Dent Neurological Institute

Buffalo, New York, 14226, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• Bansal S, Myneni AA, Mu L, Myers BH, Patel SP. Corneal sensitivity in chronic inflammatory demyelinating polyneuropathy. Cornea. 2014 Jul;33(7):703-6. doi: 10.1097/ICO.0000000000000145.

  PMID: 24858016 DERIVED

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Surbhi Bansal, M.D.

  Ross Eye Institute, University at Buffalo

  PRINCIPAL INVESTIGATOR

• Sangita Patel, M.D. PhD.

  Ross Eye Institute, University at Buffalo

  STUDY DIRECTOR

• Thomas Elmer, M.D.

  Fichte, Endl & Elmer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 23, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

US (1)