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临床试验/NCT01379833
NCT01379833已完成不适用

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

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Corneal Sensitivity

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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.

次要结局

  • Corneal nerve density

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sangita Patel

Principal Investigator

State University of New York at Buffalo

研究点 (1)

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