<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/NCT02234700</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-14-AA-0071-CTIL</org_study_id>
    <nct_id>NCT02234700</nct_id>
  </id_info>
  <brief_title>Are Corneal Epithelial Defects Related to Changes in Ocular Bacterial Flora in Patients With ANLDO</brief_title>
  <acronym>ANLDO</acronym>
  <official_title>To Estimate Whether Corneal Epithelial Defects Occur in Patients With Acquired Nasolacrimal Duct Obstructions is Linked to Changes Occurring Within Ocular Bacterial Flora in These Patients, and What Are the Specific Changes in Their Flora.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between patients with nasolacrimal duct obstruction and healthy patients and the&#xD;
      influence of their bacterial flora on the corneal epithelium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their&#xD;
      bacterial ocular flora to healthy patients without obstruction and above 18 years of age&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population.</measure>
    <time_frame>6 month</time_frame>
    <description>as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acquired Nasolacrimal Duct Obstruction</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Bacterial flora from the eye&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        30 patients with nasolacrimal duct obstruction and 30 healthy patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older, nasolacrimal duct obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger then 18 years of age&#xD;
&#xD;
          -  ocular infections&#xD;
&#xD;
          -  patients after repair of lacrimal duct surgery&#xD;
&#xD;
          -  systemic active diseases&#xD;
&#xD;
          -  patients taking medication that are know to influence bacterial flora of the eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanir Kassif, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>Medical Center of the Galilee</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>abdelhakim Ayub, MD</last_name>
    <phone>0502999110</phone>
    <email>abedayub@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Western Galileeh Hospital</name>
      <address>
        <city>Naharya</city>
        <zip>22402</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdelhakim ayub, MD</last_name>
      <phone>0502999110</phone>
      <email>abedayub@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</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>Lacrimal Duct Obstruction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02234700
org study id: TASMC-14-AA-0071-CTIL
nct id: NCT02234700
lead sponsor: 
has dmc: Yes
Comparison between patients with nasolacrimal duct obstruction and healthy patients and the
      influence of their bacterial flora on the corneal epithelium.
Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their
      bacterial ocular flora to healthy patients without obstruction and above 18 years of age
observational model: Case-Control
time perspective: Prospective
measure: the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population.
time frame: 6 month
description: as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal.
Bacterial flora from the eye
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yanir Kassif, M.D
role: Study Chair
affiliation: Medical Center of the Galilee
last name: abdelhakim Ayub, MD
phone: 0502999110
email: abedayub@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Lacrimal Duct Obstruction