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临床试验/NCT03037450
NCT03037450终止不适用

Miniinvasive Corneal Neurotization. A Pilot Study.

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
2
主要终点
Corneal sensation scores.

研究概览

简要总结

Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring, neovascularization, thinning, perforation or infection. An important and permanent visual loss of is frequently associated with the condition. NK can be congenital or acquired. Its acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic causes. There is currently no specific medical treatment. Surgical reconstruction techniques of sensory neurotizations have recently been described in young patients suffering traumatic, congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve segment into a tissue to reestablish either motor or sensory innervation. The aim of the present study is to assess the outcomes of a novel sensory neurotization technique for the treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3 centimeters) will be made in one or both eyebrow and an endoscopic device will help the surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious, traumatic or iatrogenic causes will be included.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patient older than
  • NK stages 2 and 3 (Mackie's classification).
  • Non-response to maximal medical treatment (lachrymal substitution, autologous serum).
  • Postherpetic or post-zoster NK (Group 1).
  • Postoperative NK (neurosurgery and trigeminal thermocoagulation) (Group 2).
  • Posttraumatic NK (orbital trauma, ocular burn) (Group 3).
  • No ocular hypertony in both eyes.
  • Visual acuity > 20/40 on the contralateral eye.
  • Written consent of the patient.
  • Patient benefiting from national health coverage (either as a direct user or beneficiary).

排除标准

  • Impossibility of general anesthesia.
  • Herpetic or zoster recurrence in the 6 months prior surgery.
  • Length of NK evolution > 5 years.
  • Congenital NK.
  • Bilateral NK.
  • Other causes of NK: diabeta mellitus, amylosis, sarcoidosis, multiple sclerosis, vitamin A or B12 deficiency, Sjögren syndrome, GVH disease, topical NSAID, topical beta-blockers, history of refractive surgery.
  • Mental illness.
  • Adult with legal guardian or guardianship.
  • Pregnancy.
  • Breast-feeding.
  • Patient's unable to understand informations.

结局指标

主要结局

Corneal sensation scores.

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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