<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/NCT03296111</url>
  </required_header>
  <id_info>
    <org_study_id>SDN_2017_9</org_study_id>
    <nct_id>NCT03296111</nct_id>
  </id_info>
  <brief_title>Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life</brief_title>
  <acronym>QUALVIDON</acronym>
  <official_title>Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Some patients with dry eye may have severe disabling neuropathic pain. They describe&#xD;
      spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an&#xD;
      important discordance between the high intensity of the symptoms and the poverty of the&#xD;
      clinical signs. These pains are often unrecognized and therefore often not sufficiently&#xD;
      treated. A significant impact on patient's quality of life may occur. The concept of ocular&#xD;
      neuropathic pain being relatively recent, few studies have focused on the subject at present.&#xD;
      Our study aims to shed light on these pains in patients consulting for dry eyes at the&#xD;
      Ophthalmological Foundation A. de Rothschild.&#xD;
&#xD;
      The objective of our study is to describe precisely the characteristics of neuropathic eye&#xD;
      pain and the visual, general and psychological repercussions in these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulties for patients inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Actual">October 28, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Scores obtained with each questionnaires.</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <condition>Neuralgia</condition>
  <condition>Pain</condition>
  <condition>Quality of Life</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires on pain and quality of life</intervention_name>
    <description>Patients will be asked to complete several questionnaires about their pain and the impact on their quality of life.&#xD;
They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation).&#xD;
Patients will be asked to complete several questionnaires :&#xD;
Questionnaire about the characteristics of ocular neuropathic pain (7 items)&#xD;
DEQ-5 (Dry Eye Questionnaire)&#xD;
ODI (Ocular Surface Disease Index)&#xD;
BPI (Brief Pain Inventory)&#xD;
HADS (Hospital Anxiety and Depression Scale)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with ocular neuropathic pain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 years or older,&#xD;
&#xD;
          -  Presenting at least one of the following symptoms: spontaneous pain, burning sensation&#xD;
             in eye, dysesthesia, allodynia, hyperalgesia&#xD;
&#xD;
          -  French language-skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe corneal or palpebral damage explaining current pain&#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>Fondation Ophtamologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2019</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>Neuralgia</mesh_term>
    <mesh_term>Dry Eye Syndromes</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/NCT03296111
org study id: SDN_2017_9
nct id: NCT03296111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Some patients with dry eye may have severe disabling neuropathic pain. They describe
      spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an
      important discordance between the high intensity of the symptoms and the poverty of the
      clinical signs. These pains are often unrecognized and therefore often not sufficiently
      treated. A significant impact on patient's quality of life may occur. The concept of ocular
      neuropathic pain being relatively recent, few studies have focused on the subject at present.
      Our study aims to shed light on these pains in patients consulting for dry eyes at the
      Ophthalmological Foundation A. de Rothschild.

      The objective of our study is to describe precisely the characteristics of neuropathic eye
      pain and the visual, general and psychological repercussions in these patients.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Scores obtained with each questionnaires.
time frame: baseline
intervention type: Other
intervention name: Questionnaires on pain and quality of life
description: Patients will be asked to complete several questionnaires about their pain and the impact on their quality of life.
They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation).
Patients will be asked to complete several questionnaires :
Questionnaire about the characteristics of ocular neuropathic pain (7 items)
DEQ-5 (Dry Eye Questionnaire)
ODI (Ocular Surface Disease Index)
BPI (Brief Pain Inventory)
HADS (Hospital Anxiety and Depression Scale)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Dry Eye Syndromes
sharing ipd: No