<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/NCT04412525</url>
  </required_header>
  <id_info>
    <org_study_id>S63610</org_study_id>
    <nct_id>NCT04412525</nct_id>
  </id_info>
  <brief_title>Comparative Study 27G Vitrectomy vs Larger Gauge Surgery</brief_title>
  <official_title>Comparative Study 27G Vitrectomy vs Larger Gauge Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      Two-arm, mono-center, prospective, interventional comparative case study to compare&#xD;
      postoperative recovery between the 27G and larger gauge surgical approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized comparison of postoperative recovery between 27-gauge and larger&#xD;
      gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical&#xD;
      gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters&#xD;
      or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for&#xD;
      efficiency of the procedures as well as a variety of postop indicators of pain and&#xD;
      inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">January 23, 2021</completion_date>
  <primary_completion_date type="Actual">January 23, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in post-operative outcome of pain</measure>
    <time_frame>day 1 postoperative</time_frame>
    <description>by assessing the amount of pain on a visual analogue scale (score 0-9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in post-operative outcome of redness</measure>
    <time_frame>day 1 postoperative</time_frame>
    <description>scoring the amount of redness on a scale 0-4 through eye photos</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in post-operative outcome in grading of anterior chamber cells</measure>
    <time_frame>day 1 postoperative</time_frame>
    <description>clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual acuity</measure>
    <time_frame>day 1 postoperative</time_frame>
    <description>best corrected visual acuity in LogMar will be obtained to report the visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intra-ocular pressure</measure>
    <time_frame>day 1 postoperative</time_frame>
    <description>Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain-assessment</measure>
    <time_frame>1 week postoperative</time_frame>
    <description>a questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Vitreoretinal Surgery</condition>
  <arm_group>
    <arm_group_label>27 gauge needle vitrectomy surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultra-small gauge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>larger than 27 gauge (23G or 25G) needle vitrectomy surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>23-gauge and 25-gauge instruments are a little larger in size</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>vitrectomy (27G gauge or larger needle)</intervention_name>
    <description>vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.</description>
    <arm_group_label>27 gauge needle vitrectomy surgery</arm_group_label>
    <arm_group_label>larger than 27 gauge (23G or 25G) needle vitrectomy surgery</arm_group_label>
    <other_name>vitrectomy surgery with 27G or larger needle technique</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 18&#xD;
&#xD;
          -  No prior vitrectomy surgery in the study eye (for the same eye)&#xD;
&#xD;
          -  No prior inclusion in this trial&#xD;
&#xD;
          -  Scheduled for vitrectomy for floater removal or macular surgery (including macular&#xD;
             holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is&#xD;
             allowed )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients with serious heart, lung, liver, or kidney dysfunction&#xD;
&#xD;
               -  Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes&#xD;
                  with refraction &gt;+5D or exceeding -8D , or other eye disease that impacts the&#xD;
                  outcome of vitrectomy surgery&#xD;
&#xD;
               -  Patients with HIV&#xD;
&#xD;
               -  Patients with history of drug abuse or alcoholism&#xD;
&#xD;
               -  Patients participating in other drug or medical device clinical trials before&#xD;
                  screening for this trial&#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_official>
    <last_name>Peter Stalmans, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>July 6, 2022</last_update_submitted>
  <last_update_submitted_qc>July 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT04412525/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04412525
org study id: S63610
nct id: NCT04412525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Two-arm, mono-center, prospective, interventional comparative case study to compare
      postoperative recovery between the 27G and larger gauge surgical approach.
A prospective randomized comparison of postoperative recovery between 27-gauge and larger
      gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical
      gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters
      or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for
      efficiency of the procedures as well as a variety of postop indicators of pain and
      inflammation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: changes in post-operative outcome of pain
time frame: day 1 postoperative
description: by assessing the amount of pain on a visual analogue scale (score 0-9)
measure: changes in post-operative outcome of redness
time frame: day 1 postoperative
description: scoring the amount of redness on a scale 0-4 through eye photos
measure: changes in post-operative outcome in grading of anterior chamber cells
time frame: day 1 postoperative
description: clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)
measure: visual acuity
time frame: day 1 postoperative
description: best corrected visual acuity in LogMar will be obtained to report the visual acuity
measure: intra-ocular pressure
time frame: day 1 postoperative
description: Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure
measure: pain-assessment
time frame: 1 week postoperative
description: a questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation
arm group label: 27 gauge needle vitrectomy surgery
arm group type: Active Comparator
description: ultra-small gauge
arm group label: larger than 27 gauge (23G or 25G) needle vitrectomy surgery
arm group type: Active Comparator
description: 23-gauge and 25-gauge instruments are a little larger in size
intervention type: Device
intervention name: vitrectomy (27G gauge or larger needle)
description: vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
arm group label: 27 gauge needle vitrectomy surgery
arm group label: larger than 27 gauge (23G or 25G) needle vitrectomy surgery
other name: vitrectomy surgery with 27G or larger needle technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Stalmans, PhD
role: Principal Investigator
affiliation: UZ Leuven
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No
provided document: 