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Miniinvasive Corneal Neurotization. A Pilot Study. (MICORNE)

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ClinicalTrials.gov Identifier: NCT03037450
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neurotrophic Keratitis Procedure: Miniinvasive corneal neurotization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Miniinvasive Corneal Neurotization. A Pilot Study.
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Miniinvasive corneal neurotization Procedure: Miniinvasive corneal neurotization
Neurotization of a neurotrophic cornea




Primary Outcome Measures :
  1. Corneal sensation scores. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient older than 18.
  • 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).

Exclusion Criteria:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03037450


Contacts
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Contact: Tristan Bourcier, MD 00333 ext 69.55.11.16 tristan.bourcier@chru-strasbourg.fr
Contact: Tristan Bourcier, MD 00333 ext 69.55.11.16

Locations
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France
Les Hôpitaux Universitaires Recruiting
Strasbourg, France, 67000
Contact: Tristan Bourcier, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03037450     History of Changes
Other Study ID Numbers: 6528
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratitis
Corneal Diseases
Eye Diseases