<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/NCT04404296</url>
  </required_header>
  <id_info>
    <org_study_id>20190101</org_study_id>
    <nct_id>NCT04404296</nct_id>
  </id_info>
  <brief_title>Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter</brief_title>
  <acronym>HYPE</acronym>
  <official_title>Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peregrine Eye and Laser Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peregrine Eye and Laser Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute&#xD;
      vitrectomy probe among eyes with various vitreo-retinal diseases&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a&#xD;
      25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical&#xD;
      indications. Main outcome measures included efficiency measures, postoperative pain and&#xD;
      complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">January 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Interventional case series</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time: Total</measure>
    <time_frame>6 months</time_frame>
    <description>From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scoring</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Analogue scale (0 to 4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 3 months after surgery</time_frame>
    <description>Intra- and Postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times ancillary instruments placed in eye</measure>
    <time_frame>6 months</time_frame>
    <description>Count</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Vitrectomy</condition>
  <condition>Retinal Detachment</condition>
  <condition>Vitreous Hemorrhage</condition>
  <condition>Macular Holes</condition>
  <condition>Epiretinal Membrane</condition>
  <condition>Dislocated Intraocular Lens Into Vitreous</condition>
  <condition>Retained Lens Fragments</condition>
  <arm_group>
    <arm_group_label>25-gauge 20000 PPV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Eyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy</intervention_name>
    <description>Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe</description>
    <arm_group_label>25-gauge 20000 PPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal&#xD;
             disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior PPV, glaucoma, scleral thinning, and active or recent history of (&lt;3&#xD;
             months) ocular or extra-ocular infection&#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>Harvey S Uy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peregrine Eye and Laser Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Harvey S Uy, MD</last_name>
    <phone>639175239332</phone>
    <email>harveyuy@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peregrine Eye and Laser Instittute</name>
      <address>
        <city>Makati City</city>
        <state>MM</state>
        <zip>1209</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rheamel Navarro</last_name>
      <phone>+63288900115</phone>
      <email>rheanavarro82@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Pik Sha Chan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jordan Famadico, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>April 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 2, 2021</last_update_submitted>
  <last_update_submitted_qc>June 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peregrine Eye and Laser Institute</investigator_affiliation>
    <investigator_full_name>Harvey Siy Uy</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>Small gauge vitrectomy probe</keyword>
  <keyword>20000 cut per minute</keyword>
  <keyword>Microincisional vitrectomy system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Retinal Perforations</mesh_term>
    <mesh_term>Epiretinal Membrane</mesh_term>
    <mesh_term>Vitreous Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</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/NCT04404296
org study id: 20190101
nct id: NCT04404296
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute
      vitrectomy probe among eyes with various vitreo-retinal diseases
We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a
      25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical
      indications. Main outcome measures included efficiency measures, postoperative pain and
      complications.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Interventional case series
primary purpose: Treatment
masking: None (Open Label)
measure: Operative time: Total
time frame: 6 months
description: From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch
measure: Pain scoring
time frame: 6 months
description: Visual Analogue scale (0 to 4)
measure: Adverse events
time frame: Up to 3 months after surgery
description: Intra- and Postoperative complications
measure: Number of times ancillary instruments placed in eye
time frame: 6 months
description: Count
arm group label: 25-gauge 20000 PPV
arm group type: Other
description: Eyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
intervention type: Device
intervention name: 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
description: Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
arm group label: 25-gauge 20000 PPV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harvey S Uy, MD
role: Principal Investigator
affiliation: Peregrine Eye and Laser Institute
last name: Harvey S Uy, MD
phone: 639175239332
email: harveyuy@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Philippines
responsible party type: Principal Investigator
investigator affiliation: Peregrine Eye and Laser Institute
investigator full name: Harvey Siy Uy
investigator title: Medical Director
mesh term: Retinal Detachment
mesh term: Retinal Perforations
mesh term: Epiretinal Membrane
mesh term: Vitreous Hemorrhage
mesh term: Hemorrhage
sharing ipd: No