<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/NCT04498624</url>
  </required_header>
  <id_info>
    <org_study_id>0062156</org_study_id>
    <nct_id>NCT04498624</nct_id>
  </id_info>
  <brief_title>Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes</brief_title>
  <official_title>Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</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>
      Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy&#xD;
      for idiopathic full thickness macular holes with inverted flap technique versus internal&#xD;
      limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change&#xD;
      after primary vitrectomy for idiopathic full thickness macular holes with inverted flap&#xD;
      technique versus internal limiting membrane (ILM) peeling technique; difference in closure&#xD;
      rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap&#xD;
      technique versus internal limiting membrane (ILM) peeling technique&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microperimetry retinal sensitivity</measure>
    <time_frame>3 months</time_frame>
    <description>Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity (BCVA)</measure>
    <time_frame>3 months</time_frame>
    <description>Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Closure rate</measure>
    <time_frame>3 months</time_frame>
    <description>Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Full Thickness Macular Hole</condition>
  <arm_group>
    <arm_group_label>inverted flap</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>peeling internal limiting membrane (ILM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inverted flap</intervention_name>
    <description>full thickness macular hole surgery</description>
    <arm_group_label>inverted flap</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>peeling internal limiting membrane (ILM)</intervention_name>
    <description>full thickness macular hole surgery</description>
    <arm_group_label>peeling internal limiting membrane (ILM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  idiopathic full thickness macular hole ≤ 350 micron of diameter&#xD;
&#xD;
          -  phakic or pseudophakic&#xD;
&#xD;
          -  absence of systemic adverse conditions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concomitant retinal and other ocular disease&#xD;
&#xD;
          -  previous ocular surgery except cataract surgery&#xD;
&#xD;
          -  axial length &gt;26mm&#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>MIchele Reibaldi, MD</last_name>
    <phone>0116331863</phone>
    <email>michele.reibaldi@unito.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MIchele Reibaldi, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Michele Reibaldi</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Full thickness macular hole</keyword>
  <keyword>Vitrectomy</keyword>
  <keyword>Inverted flap</keyword>
  <keyword>Internal limiting membrane peeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</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/NCT04498624
org study id: 0062156
nct id: NCT04498624
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy
      for idiopathic full thickness macular holes with inverted flap technique versus internal
      limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change
      after primary vitrectomy for idiopathic full thickness macular holes with inverted flap
      technique versus internal limiting membrane (ILM) peeling technique; difference in closure
      rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap
      technique versus internal limiting membrane (ILM) peeling technique
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Microperimetry retinal sensitivity
time frame: 3 months
description: Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
measure: Best corrected visual acuity (BCVA)
time frame: 3 months
description: Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
measure: Closure rate
time frame: 3 months
description: Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
arm group label: inverted flap
arm group type: Active Comparator
arm group label: peeling internal limiting membrane (ILM)
arm group type: Active Comparator
intervention type: Procedure
intervention name: inverted flap
description: full thickness macular hole surgery
arm group label: inverted flap
intervention type: Procedure
intervention name: peeling internal limiting membrane (ILM)
description: full thickness macular hole surgery
arm group label: peeling internal limiting membrane (ILM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MIchele Reibaldi, MD
phone: 0116331863
email: michele.reibaldi@unito.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Michele Reibaldi
investigator title: Prof.
mesh term: Retinal Perforations
sharing ipd: Undecided