<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/NCT04472039</url>
  </required_header>
  <id_info>
    <org_study_id>RAC</org_study_id>
    <nct_id>NCT04472039</nct_id>
  </id_info>
  <brief_title>Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling</brief_title>
  <official_title>Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vienna Institute for Research in Ocular Surgery</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</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>
      Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after&#xD;
      pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone&#xD;
      acetonide and to examine possible risk factors for postoperative intraretinal cystoid&#xD;
      changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia.&#xD;
      Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM.&#xD;
      Nevertheless, there are about 10% of patients having intraretinal cystoid changes after&#xD;
      surgery with potential for disturbance of visual acuity. The aim of the study is to assess&#xD;
      the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with&#xD;
      membrane peeling and peribulbar application of triamcinolone acetonide and to examine&#xD;
      possible risk factors for postoperative intraretinal cystoid changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">September 28, 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>Intraretinal cystoid changes</measure>
    <time_frame>3 months</time_frame>
    <description>presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraocular pressure (IOP)</measure>
    <time_frame>3 months</time_frame>
    <description>intraocular pressure is examined during the time period of 3 months after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distance corrected visual acuity</measure>
    <time_frame>3 months</time_frame>
    <description>distance corrected visual acuity is measured at baseline and 3 months after surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Macular Edema, Cystoid</condition>
  <arm_group>
    <arm_group_label>Studygroup</arm_group_label>
    <description>Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>optical coherence tomography (OCT)</intervention_name>
    <description>OCT visualizes the retinal layers by backreflection of light</description>
    <arm_group_label>Studygroup</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having undergone pars plana vitrectomy with membrane peeling and periocular&#xD;
        application of triamcinolone acetonide at the end of surgery between June 2019 and January&#xD;
        2020 at the department of Ophthalmology of the Hanusch Hospital in Vienna, Austria, were&#xD;
        selected for the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of an ERM&#xD;
&#xD;
          -  indication for membrane peeling defined as significant loss of vision and/or&#xD;
             metamorphopsia due to the ERM&#xD;
&#xD;
          -  application of periocular triamcinolone acetonide at the end of surgery&#xD;
&#xD;
          -  at least one follow-up examination present in the patient's history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  macular edema caused by conditions other than ERM (such as choroidal&#xD;
             neovascularization, diabetic macular edema, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Oliver Findl, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vienna Institute for Research in Ocular Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Prof. Dr. Oliver Findl, MBA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</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/NCT04472039
org study id: RAC
nct id: NCT04472039
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after
      pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone
      acetonide and to examine possible risk factors for postoperative intraretinal cystoid
      changes.
Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia.
      Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM.
      Nevertheless, there are about 10% of patients having intraretinal cystoid changes after
      surgery with potential for disturbance of visual acuity. The aim of the study is to assess
      the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with
      membrane peeling and peribulbar application of triamcinolone acetonide and to examine
      possible risk factors for postoperative intraretinal cystoid changes.
observational model: Case-Control
time perspective: Retrospective
measure: Intraretinal cystoid changes
time frame: 3 months
description: presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery
measure: intraocular pressure (IOP)
time frame: 3 months
description: intraocular pressure is examined during the time period of 3 months after surgery
measure: distance corrected visual acuity
time frame: 3 months
description: distance corrected visual acuity is measured at baseline and 3 months after surgery
arm group label: Studygroup
description: Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history.
intervention type: Device
intervention name: optical coherence tomography (OCT)
description: OCT visualizes the retinal layers by backreflection of light
arm group label: Studygroup
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Oliver Findl, Prof.
role: Principal Investigator
affiliation: Vienna Institute for Research in Ocular Surgery
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Prof. Dr. Oliver Findl, MBA
mesh term: Macular Edema