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

Related Clinical Trial
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) CIDP07 Rozanolixizumab Post Trial Access Program (the PTA) Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Hizentra® in Inflammatory Neuropathies – pHeNIx Study Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC) InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Study Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy A Registered Cohort Study of Immune-Mediated Neuropathies Interest of Mycophenolate for CIDP Weaning Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Transcriptome Analysis of the Peripheral Blood in CIDP Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP Subcutaneous Immunoglobulin for CIDP Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy MRI in Diagnosing and Monitoring CIDP High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy. IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Panzyga in CIDP Administered at Different Infusion Rates Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Brief Title

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

Official Title

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

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.
    

Detailed Description

      INTRODUCTION The prevalence of CIDP ranges from 0.8 to 8.4 per 100 000.5 This broad range may
      reflect the use of different diagnostic criteria, as recently confirmed by an epidemiologic
      study on UK population. Over 50% of the patients may have temporary severe disability during
      the course of their disease and approximately 10% eventually become persistently disabled or
      die because of the illness.

      CIDP may affect any nerve plexus in the body. However, diagnostic criteria leans towards
      nerve conduction studies in the limbs and denervation in other organ systems might be
      overlooked. Sensory innervation of the cornea is provided by the ophthalmic branch of the
      trigeminal nerve via the anterior ciliary nerves. A relatively small number (50-450) of
      primary sensory neurons from the ipsilateral trigeminal ganglion send their peripheral axons
      to the cornea and branch extensively within the corneal tissue. To maintain corneal
      transparency, all peripheral axons of corneal neurons lose the myelin sheath when they enter
      the corneal stroma. Fibers spread in a radial fashion parallel to the corneal surface.1

      Our proposed study will explore the relationship of decreased corneal sensation, a
      potentially devastating eye condition secondary to CIDP. Decreased corneal sensation may lead
      to neurotrophic keratitis; which describes corneal diseases due to impairment or loss of
      corneal sensation leading to epithelial defects and corneal ulcers. This may be caused by
      many ocular and systemic diseases such as Diabetes or Stroke. Corneal innervation is
      important for the maintenance of corneal structure and function, and provides protective
      mechanisms against factors that might be potentially damaging to the cornea. Innervation also
      plays an important trophic function in corneal repair in relation to disease, trauma or
      surgery. Denervation and decreased corneal sensitivity are associated with impairment of
      epithelial and endothelial cell function, increased epithelial and endothelial permeability,
      decreased cell migration and cell mitosis. In addition, denervated corneas are predisposed to
      epithelial or stromal abnormalities, recurrent erosion, impaired wound healing and
      infection.2

      Although corneal nerves lose their myelin sheath as they enter the stroma, the association of
      a demyelinating disease affecting these nerves cannot be excluded. This may be because
      trigeminal nerves can be affected at different levels (the nucleus in the pons, the Gasserian
      ganglion, the trigeminal ophthalmic branch, the nasociliary nerve, or the long ciliary
      nerve). Also, nerves without central myelin throughout their length can be affected in CIDP.
      For example, CNVIII has peculiar myelin as it has central myelin for the majority of its
      length, except for a short distal segment which has peripheral myelin.6 There is one case
      report correlating findings of hearing loss and vestibular dysfunction for over a 6-year
      period in patients with CIDP.

      OUR STUDY

      We plan a prospective clinical trial to compare prevalence of decreased corneal sensation and
      possible decrease in corneal nerves in patients with CIDP previously diagnosed by clinical
      features and electrophysiologic data as outlined by the American Academy of Neurology10 as
      compared to patients without CIDP. Patients will be categorized according to the severity of
      the disease and duration as per their medical records. Exclusion criteria is aimed at those
      conditions which may reduce corneal sensation such as previous eye trauma, surgery, contact
      lens use, eye drop use, or previous viral infections of the eye. A routine complete eye exam
      will be performed along with additional testing for corneal sensation using a standard
      method. If significant findings are obtained during initial eye exam, subjects will obtain
      in-vivo confocal imaging at a second site to image corneal nerve fibers. Published standards
      for corneal sensitivity as well as corneal nerve fiber density via confocal imaging will be
      used in statistical analysis.

      SIGNIFICANCE OF THIS STUDY

      Experimental evidence indicates that impairment of corneal sensory nerves induces
      pathological changes in the anatomic integrity and function of the cornea, particularly in
      the epithelium. Loss of corneal sensory innervations leads to a decrease in thickness of the
      corneal epithelium, intracellular swelling, loss of microvilli and abnormal production of the
      basal lamina. This may lead to impairment in vitality, metabolism, and mitosis of epithelial
      cells and, consequently, epithelial breakdown. Persistent epithelial defects may lead to
      chronic ulceration and eventually to compromise of all ocular surface components with severe
      visual impairment.

      If an association is found between CIDP and decreased corneal sensation, this study will be
      the first one to demonstrate such an association. An increased awareness among physicians
      about this association may lead to a more careful eye exam in patients with CIDP and
      detection of early changes of ocular disease which may be treated earlier so that serious
      blinding complications can be avoided.

      FUTURE STUDIES

      If a positive association is found between CIDP and decreased corneal sensation, the latter
      may be added as a supportive criteria in grading the severity of CIDP. CIDP has many
      treatment modalities available according to its severity and clinical course. Finding
      decreased corneal sensation in CIDP patients prospectively may lead to a diagnosis of
      increased disease severity and patients may benefit from more aggressive treatments.
    


Study Type

Observational


Primary Outcome

Corneal Sensitivity

Secondary Outcome

 Corneal nerve density

Condition

Chronic Inflammatory Demyelinating Polyneuropathy


Study Arms / Comparison Groups

 Subjects
Description:  Subjects are patients with CIDP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

18

Start Date

May 2011

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility 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.
      

Gender

All

Ages

18 Years - 110 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Surbhi Bansal, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01379833

Organization ID

OPT0120511


Responsible Party

Principal Investigator

Study Sponsor

State University of New York at Buffalo

Collaborators

 Dent Neurological Institute, Buffalo, NY

Study Sponsor

Surbhi Bansal, M.D., Principal Investigator, Ross Eye Institute, University at Buffalo


Verification Date

June 2019