xml: <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/NCT06040216</url>
    </required_header>
    <id_info>
      <org_study_id>KocaeliUniversity</org_study_id>
      <nct_id>NCT06040216</nct_id>
    </id_info>
    <brief_title>Evolution of EIFL Following PPV</brief_title>
    <official_title>Long-term Follow-up Results of Ectopic Inner Foveal Retinal Layers Evolution Following Pars Plana Vitrectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kocaeli University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kocaeli University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Various classification systems have been described for epiretinal membrane (ERM). One of them&#xD;
        is a new OCT-based staging scheme based on displacement and reorganization of inner retinal&#xD;
        layers called ectopic inner retinal layers (EIFL). We evaluated pre-and perioperative factors&#xD;
        related to time for evolution of EIFL.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2020</start_date>
    <completion_date type="Actual">March 17, 2020</completion_date>
    <primary_completion_date type="Actual">March 17, 2020</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Best corrected visual acuity</measure>
      <time_frame>1-month</time_frame>
      <description>Best corrected visual acuity</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">80</enrollment>
    <condition>Epiretinal Membrane</condition>
    <arm_group>
      <arm_group_label>Stage 2 ERM</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Stage 3 ERM</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Stage 4 ERM</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>optical coherence tomography</intervention_name>
      <description>We observed the postoperative improvement in EIFL severity with optical coherence tomography</description>
      <arm_group_label>Stage 2 ERM</arm_group_label>
      <arm_group_label>Stage 3 ERM</arm_group_label>
      <arm_group_label>Stage 4 ERM</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This retrospective study included 81 consecutive eyes with idiopathic epiretinal membrane&#xD;
          that underwent vitrectomy surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing idiopathic epiretinal membrane surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing seconder epiretinal membrane surgery&#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>Kocaeli University School of Medicine</name>
        <address>
          <city>Kocaeli</city>
          <state>None Selected</state>
          <zip>41001</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kocaeli University</investigator_affiliation>
      <investigator_full_name>Levent Karabas</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epiretinal Membrane</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040216
  org study id: KocaeliUniversity
  nct id: NCT06040216
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Various classification systems have been described for epiretinal membrane (ERM). One of them
        is a new OCT-based staging scheme based on displacement and reorganization of inner retinal
        layers called ectopic inner retinal layers (EIFL). We evaluated pre-and perioperative factors
        related to time for evolution of EIFL.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Best corrected visual acuity
  time frame: 1-month
  description: Best corrected visual acuity
  arm group label: Stage 2 ERM
  arm group label: Stage 3 ERM
  arm group label: Stage 4 ERM
  intervention type: Other
  intervention name: optical coherence tomography
  description: We observed the postoperative improvement in EIFL severity with optical coherence tomography
  arm group label: Stage 2 ERM
  arm group label: Stage 3 ERM
  arm group label: Stage 4 ERM
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kocaeli University
  investigator full name: Levent Karabas
  investigator title: Prof. Dr.
  mesh term: Epiretinal Membrane
  sharing ipd: No