<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/NCT04445142</url>
  </required_header>
  <id_info>
    <org_study_id>200402</org_study_id>
    <nct_id>NCT04445142</nct_id>
  </id_info>
  <brief_title>Fovea ERM After Fovea-sparing ILM Peeling</brief_title>
  <official_title>Severe Foveal Epiretinal Membrane Contraction After Previous Fovea-sparing Internal Limiting Membrane Peeling Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</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>
      To report cases who had received previous fovea-sparing internal limiting peeling membrane&#xD;
      and developed secondary fovea epiretinal membrane contraction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on&#xD;
      residual internal limiting membrane (ILM) with severe contraction after previous&#xD;
      fovea-sparing internal limiting membrane (ILM) peeling.&#xD;
&#xD;
      Study design: Retrospective case series Methods: We report patients who previously received&#xD;
      fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Snellen visual acuity change</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Optical coherence tomography finding</measure>
    <time_frame>6 months</time_frame>
    <description>fovea change on optical coherence tomography</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Epiretinal Membrane</condition>
  <condition>Internal Limiting Membrane Wrinkling</condition>
  <arm_group>
    <arm_group_label>epiretinal membrane group</arm_group_label>
    <description>Patients developed secondary fovea epiretinal membrane</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fovea-sparing internal limiting membrane peeling</intervention_name>
    <description>fovea-sparing internal limiting membrane peeling surgery</description>
    <arm_group_label>epiretinal membrane group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who developed secondary fovea epiretinal membrane after previous fovea-sparing&#xD;
        internal limiting membrane surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who developed secondary fovea epiretinal membrane after previous&#xD;
             fovea-sparing internal limiting membrane surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who did not receive previous fovea-sparing internal limiting membrane surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>San-Ni Chen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of ophthalmology, Changhua Christian Hospital</name>
      <address>
        <city>Changhua City</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>San Ni Chen</investigator_full_name>
    <investigator_title>Head of department of ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Fovea-sparing internal limiting membrane peeling</keyword>
  <keyword>Epiretinal membrane.</keyword>
  <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>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04445142
org study id: 200402
nct id: NCT04445142
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To report cases who had received previous fovea-sparing internal limiting peeling membrane
      and developed secondary fovea epiretinal membrane contraction
Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on
      residual internal limiting membrane (ILM) with severe contraction after previous
      fovea-sparing internal limiting membrane (ILM) peeling.

      Study design: Retrospective case series Methods: We report patients who previously received
      fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.
observational model: Case-Only
time perspective: Retrospective
measure: Visual acuity
time frame: 6 months
description: Snellen visual acuity change
measure: Optical coherence tomography finding
time frame: 6 months
description: fovea change on optical coherence tomography
arm group label: epiretinal membrane group
description: Patients developed secondary fovea epiretinal membrane
intervention type: Procedure
intervention name: fovea-sparing internal limiting membrane peeling
description: fovea-sparing internal limiting membrane peeling surgery
arm group label: epiretinal membrane group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: San-Ni Chen, MD
role: Study Chair
affiliation: Changhua Christian Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: San Ni Chen
investigator title: Head of department of ophthalmology
mesh term: Epiretinal Membrane
sharing ipd: Undecided