<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/NCT02210481</url>
  </required_header>
  <id_info>
    <org_study_id>AOL2010-02</org_study_id>
    <nct_id>NCT02210481</nct_id>
  </id_info>
  <brief_title>The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane</brief_title>
  <acronym>GLU-MAC</acronym>
  <official_title>Impact of Intravitreal Glucose Rate in Macular Thinning Following Retinal Detachment or Epimacular Membrane Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between intravitreous glucose rate and macular thinning measured by Ocular&#xD;
      Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular&#xD;
      membrane. Hypothesis : Association between post-operative macular thickness and intravitreous&#xD;
      glucose rate&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3&#xD;
      months post vitrectomy for retinal detachment or epimacular membrane. The cohort is divided&#xD;
      in 2 groups, one with the thinnest macular measurement under 190µm, and the others above&#xD;
      190µm. We are looking for a correlation between increasing glucose rates and decreased&#xD;
      macular thickness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>macular thickness measured by OCT</measure>
    <time_frame>3 months post-operatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual acuity</measure>
    <time_frame>3 months post-operatively</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Vitrectomy</condition>
  <condition>Macular Thinning</condition>
  <arm_group>
    <arm_group_label>GLUC-MAC-COHORT</arm_group_label>
    <description>post vitrectomy for retinal detachment or epimacular membrane patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        cohort composed of patients undergoing vitrectomy for retinal detachment or epimacular&#xD;
        membrane at Reims University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient who underwent vitrectomy for retinal detachment or epimacular membrane&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient suffering of diabetes,&#xD;
&#xD;
          -  recurrence of retinal detachment,&#xD;
&#xD;
          -  age-related macular degeneration,&#xD;
&#xD;
          -  post surgical macular oedema&#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>Centre Hospitalier Universitaire de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitrectomy,</keyword>
  <keyword>macular thinning,</keyword>
  <keyword>retinal detachment,</keyword>
  <keyword>epimacular membrane,</keyword>
  <keyword>intravitreal glucose,</keyword>
  <keyword>OCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Epiretinal Membrane</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/NCT02210481
org study id: AOL2010-02
nct id: NCT02210481
lead sponsor: 
has dmc: No
Comparison between intravitreous glucose rate and macular thinning measured by Ocular
      Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular
      membrane. Hypothesis : Association between post-operative macular thickness and intravitreous
      glucose rate
Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3
      months post vitrectomy for retinal detachment or epimacular membrane. The cohort is divided
      in 2 groups, one with the thinnest macular measurement under 190µm, and the others above
      190µm. We are looking for a correlation between increasing glucose rates and decreased
      macular thickness.
observational model: Cohort
time perspective: Prospective
measure: macular thickness measured by OCT
time frame: 3 months post-operatively
measure: visual acuity
time frame: 3 months post-operatively
arm group label: GLUC-MAC-COHORT
description: post vitrectomy for retinal detachment or epimacular membrane patients
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: Retinal Detachment
mesh term: Epiretinal Membrane