<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037450</url>
  </required_header>
  <id_info>
    <org_study_id>6528</org_study_id>
    <nct_id>NCT03037450</nct_id>
  </id_info>
  <brief_title>Miniinvasive Corneal Neurotization. A Pilot Study.</brief_title>
  <acronym>MICORNE</acronym>
  <official_title>Miniinvasive Corneal Neurotization. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of&#xD;
      the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several&#xD;
      corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring,&#xD;
      neovascularization, thinning, perforation or infection. An important and permanent visual&#xD;
      loss of is frequently associated with the condition. NK can be congenital or acquired. Its&#xD;
      acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic&#xD;
      causes. There is currently no specific medical treatment. Surgical reconstruction techniques&#xD;
      of sensory neurotizations have recently been described in young patients suffering traumatic,&#xD;
      congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural&#xD;
      nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve&#xD;
      segment into a tissue to reestablish either motor or sensory innervation. The aim of the&#xD;
      present study is to assess the outcomes of a novel sensory neurotization technique for the&#xD;
      treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal&#xD;
      neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve&#xD;
      (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of&#xD;
      the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3&#xD;
      centimeters) will be made in one or both eyebrow and an endoscopic device will help the&#xD;
      surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be&#xD;
      sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious,&#xD;
      traumatic or iatrogenic causes will be included.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The reasons for stopping the research are :&#xD;
&#xD;
      -  Inclusion difficulties (demanding inclusion and exclusion criteria),&#xD;
&#xD;
      -  The Covid-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">January 22, 2019</completion_date>
  <primary_completion_date type="Actual">January 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal sensation scores.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Neurotrophic Keratitis</condition>
  <arm_group>
    <arm_group_label>Miniinvasive corneal neurotization</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Miniinvasive corneal neurotization</intervention_name>
    <description>Neurotization of a neurotrophic cornea</description>
    <arm_group_label>Miniinvasive corneal neurotization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18.&#xD;
&#xD;
          -  NK stages 2 and 3 (Mackie's classification).&#xD;
&#xD;
          -  Non-response to maximal medical treatment (lachrymal substitution, autologous serum).&#xD;
&#xD;
          -  Postherpetic or post-zoster NK (Group 1).&#xD;
&#xD;
          -  Postoperative NK (neurosurgery and trigeminal thermocoagulation) (Group 2).&#xD;
&#xD;
          -  Posttraumatic NK (orbital trauma, ocular burn) (Group 3).&#xD;
&#xD;
          -  No ocular hypertony in both eyes.&#xD;
&#xD;
          -  Visual acuity &gt; 20/40 on the contralateral eye.&#xD;
&#xD;
          -  Written consent of the patient.&#xD;
&#xD;
          -  Patient benefiting from national health coverage (either as a direct user or&#xD;
             beneficiary).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibility of general anesthesia.&#xD;
&#xD;
          -  Herpetic or zoster recurrence in the 6 months prior surgery.&#xD;
&#xD;
          -  Length of NK evolution &gt; 5 years.&#xD;
&#xD;
          -  Congenital NK.&#xD;
&#xD;
          -  Bilateral NK.&#xD;
&#xD;
          -  Other causes of NK: diabeta mellitus, amylosis, sarcoidosis, multiple sclerosis,&#xD;
             vitamin A or B12 deficiency, Sjögren syndrome, GVH disease, topical NSAID, topical&#xD;
             beta-blockers, history of refractive surgery.&#xD;
&#xD;
          -  Mental illness.&#xD;
&#xD;
          -  Adult with legal guardian or guardianship.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Breast-feeding.&#xD;
&#xD;
          -  Patient's unable to understand informations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Les Hôpitaux Universitaires</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037450
org study id: 6528
nct id: NCT03037450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Corneal sensation scores.
time frame: 12 months
arm group label: Miniinvasive corneal neurotization
arm group type: Other
intervention type: Procedure
intervention name: Miniinvasive corneal neurotization
description: Neurotization of a neurotrophic cornea
arm group label: Miniinvasive corneal neurotization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Keratitis
sharing ipd: No