<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/NCT03289806</url>
  </required_header>
  <id_info>
    <org_study_id>DELAZZER 2016</org_study_id>
    <nct_id>NCT03289806</nct_id>
  </id_info>
  <brief_title>Effects of DHA on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery</brief_title>
  <acronym>DHA</acronym>
  <official_title>Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to&#xD;
      a renewed increase in intraocular pressure. The use of anti-metabolites over many years has&#xD;
      made it possible to improve success rates for this surgery but these drugs have numerous&#xD;
      adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe&#xD;
      that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates&#xD;
      in this surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 12, 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Test migration ability by video microscopy</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Test proliferation with immunohistochemistry (Ki67 staining)</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of cell cycle in flow cytometry</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Trabulectomy</condition>
  <condition>Deep Sclerectomy</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Glaucoma surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Strabismus surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Samples of fibroblasts from Tenon's capsule</intervention_name>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      fibroblasts of Tenon's capsule (surgical waste)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery for glaucoma or strabismus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing trabulectomy or deep sclerectomy&#xD;
&#xD;
          -  Patients informed about the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients who refuse to take part in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alain BRON</last_name>
    <phone>03 80 29 37 56</phone>
    <phone_ext>+33</phone_ext>
    <email>alain.bron@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain BRON</last_name>
      <phone>03 80 29 37 56</phone>
      <phone_ext>+33</phone_ext>
      <email>alain.bron@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</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>Glaucoma</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/NCT03289806
org study id: DELAZZER 2016
nct id: NCT03289806
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to
      a renewed increase in intraocular pressure. The use of anti-metabolites over many years has
      made it possible to improve success rates for this surgery but these drugs have numerous
      adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe
      that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates
      in this surgery.
observational model: Case-Control
time perspective: Prospective
measure: Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)
time frame: At baseline
measure: Test migration ability by video microscopy
time frame: At baseline
measure: Test proliferation with immunohistochemistry (Ki67 staining)
time frame: At baseline
measure: Analysis of cell cycle in flow cytometry
time frame: At baseline
arm group label: Cases
description: Glaucoma surgery
arm group label: Controls
description: Strabismus surgery
intervention type: Procedure
intervention name: Samples of fibroblasts from Tenon's capsule
arm group label: Cases
arm group label: Controls
fibroblasts of Tenon's capsule (surgical waste)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alain BRON
phone: 03 80 29 37 56
phone ext: +33
email: alain.bron@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Glaucoma