<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/NCT01716507</url>
  </required_header>
  <id_info>
    <org_study_id>23VS20RD</org_study_id>
    <secondary_id>IRB08858</secondary_id>
    <nct_id>NCT01716507</nct_id>
  </id_info>
  <brief_title>23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments</brief_title>
  <official_title>A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation&#xD;
      for retinal detachment repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation.&#xD;
      Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No&#xD;
      studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary&#xD;
      pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal&#xD;
      preference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the initial retinal reattachment rates by comparing the percentages/amount.</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in best-corrected visual acuity by comparing letters read.</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the change in best-corrected visual acuity (BCVA) at the pre-operative visit compared to the 6 month post-operative visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.</measure>
    <time_frame>1 year</time_frame>
    <description>To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating time for 23 gauge versus 20 gauge PPV (time measurement)</measure>
    <time_frame>1 day- Day of surgery</time_frame>
    <description>This will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.</measure>
    <time_frame>1 year</time_frame>
    <description>To describe and compare rates of intraoperative and postoperative complications with 23-gauge versus 20-gauge PPV for primary repair of PRD, including but not limited to post-operative hypotony, choroidal detachment, proliferative vitreoretinopathy, and endophthalmitis.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Retinal Detachment</condition>
  <arm_group>
    <arm_group_label>20 gauge pars plana vitrectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 gauge pars plana vitrectomy for retinal detachment repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>23 gauge pars plana vitrectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>23 gauge pars plana vitrectomy for retinal detachment repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retinal Detachment repair</intervention_name>
    <description>Comparing 23 gauge vs 20 gauge pars plana vitrectomy.</description>
    <arm_group_label>20 gauge pars plana vitrectomy</arm_group_label>
    <arm_group_label>23 gauge pars plana vitrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide written consent and comply with study assessments for the full&#xD;
             duration of the study.&#xD;
&#xD;
          -  Presence of retinal detachment with history of cataract surgery.&#xD;
&#xD;
          -  Vision of hand motion or better.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a very large tear or type of retinal detachment usually a result of&#xD;
             trauma.&#xD;
&#xD;
          -  Prior eye surgery except for cataract surgery.&#xD;
&#xD;
          -  Presence of significant scar tissue.&#xD;
&#xD;
          -  Presence of retinal detachment due to hole in the macula.&#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>Jason Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wills Eye</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mid Atlantic Retina</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RRD</keyword>
  <keyword>Rhegmatogenous</keyword>
  <keyword>Retinal</keyword>
  <keyword>Detachment</keyword>
  <keyword>PPV</keyword>
  <keyword>Pars Plana Vitrectomy</keyword>
  <keyword>Gauge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Dissociative Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01716507
org study id: 23VS20RD
secondary id: IRB08858
nct id: NCT01716507
lead sponsor: 
has dmc: No
This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation
      for retinal detachment repair.
The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation.
      Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No
      studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary
      pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal
      preference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assess the initial retinal reattachment rates by comparing the percentages/amount.
time frame: 1 Year
measure: Change in best-corrected visual acuity by comparing letters read.
time frame: 6 months
description: To determine the change in best-corrected visual acuity (BCVA) at the pre-operative visit compared to the 6 month post-operative visit
measure: Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.
time frame: 1 year
description: To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.
measure: Operating time for 23 gauge versus 20 gauge PPV (time measurement)
time frame: 1 day- Day of surgery
description: This will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.
measure: Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.
time frame: 1 year
description: To describe and compare rates of intraoperative and postoperative complications with 23-gauge versus 20-gauge PPV for primary repair of PRD, including but not limited to post-operative hypotony, choroidal detachment, proliferative vitreoretinopathy, and endophthalmitis.
arm group label: 20 gauge pars plana vitrectomy
arm group type: Other
description: 20 gauge pars plana vitrectomy for retinal detachment repair
arm group label: 23 gauge pars plana vitrectomy
arm group type: Other
description: 23 gauge pars plana vitrectomy for retinal detachment repair
intervention type: Procedure
intervention name: Retinal Detachment repair
description: Comparing 23 gauge vs 20 gauge pars plana vitrectomy.
arm group label: 20 gauge pars plana vitrectomy
arm group label: 23 gauge pars plana vitrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Hsu, MD
role: Principal Investigator
affiliation: Wills Eye
facility: 
country: United States
responsible party type: Sponsor
mesh term: Retinal Detachment
mesh term: Dissociative Disorders
sharing ipd: No