<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/NCT04455399</url>
  </required_header>
  <id_info>
    <org_study_id>20200102</org_study_id>
    <nct_id>NCT04455399</nct_id>
  </id_info>
  <brief_title>Time Efficiency Comparison of Two IntraVitreal Injection Techniques</brief_title>
  <acronym>TIVI</acronym>
  <official_title>Time Efficiency Comparison of Two Intravitreal Injection Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peregrine Eye and Laser Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency&#xD;
      and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique&#xD;
      using a dual blade speculum among patients undergoing IVI for various indications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and&#xD;
      safety of a single-use IIG with a traditional technique using a dual blade speculum among&#xD;
      patients undergoing IVI for various indications.&#xD;
&#xD;
      The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for&#xD;
      neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV),&#xD;
      diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane&#xD;
      from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history&#xD;
      of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral&#xD;
      thinning, history of previous glaucoma surgery, history of pars plana vitrectomy,&#xD;
      hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand&#xD;
      the informed consent form.&#xD;
&#xD;
      The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal&#xD;
      injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random&#xD;
      number generator will be used to generate an odd or even number for each eye. Odd eyes will&#xD;
      be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection,&#xD;
      once the first eye is randomized to one technique, the second eye will be automatically&#xD;
      assigned to the other technique. The study will be conducted in compliance with the&#xD;
      Declaration of Helsinki. All patients will provide informed consent prior to start of study&#xD;
      procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Actual">January 9, 2021</completion_date>
  <primary_completion_date type="Actual">January 9, 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>
    <intervention_model_description>Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of intravitreal injection procedure</measure>
    <time_frame>At time of injection procedure</time_frame>
    <description>Duration in seconds from application to removal of single-blade or dual blade speculum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>Immediately and up to 1 month after the intravitreal injection procedure</time_frame>
    <description>Frequency of adverse events and serious adverse events after intravitreal injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient preference for IVI technique</measure>
    <time_frame>Immediately post injection using single-blade speculum</time_frame>
    <description>Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <condition>Diabetic Macular Edema</condition>
  <condition>Retinal Vein Occlusion With Macular Edema</condition>
  <condition>Uveitic Macular Edema</condition>
  <condition>Choroidal Neovascularization</condition>
  <arm_group>
    <arm_group_label>Intravitreal injection guide</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual blade eyelid speculum</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intravitreal injection guide (Malosa)</intervention_name>
    <description>A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion</description>
    <arm_group_label>Intravitreal injection guide</arm_group_label>
    <other_name>Malosa intravitreal injection guide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual Blade Eyelid Speculum</intervention_name>
    <description>A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.</description>
    <arm_group_label>Dual blade eyelid speculum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        * Eyes of adult patients requiring intravitreally injected medications for non-infectious&#xD;
        indications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of extraocular or intraocular infection within 3 months of the scheduled IVI&#xD;
             date&#xD;
&#xD;
          -  Scleral thinning&#xD;
&#xD;
          -  History of previous glaucoma surgery&#xD;
&#xD;
          -  History of pars plana vitrectomy&#xD;
&#xD;
          -  Hypersensitivity to the IVI drug, proparacaine or povidone iodine&#xD;
&#xD;
          -  Inability to understand the informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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>
  <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>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>April 25, 2021</last_update_submitted>
  <last_update_submitted_qc>April 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 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>intravitreal injection</keyword>
  <keyword>intravitreal injecton guide</keyword>
  <keyword>macular edema</keyword>
  <keyword>time efficiency</keyword>
  <keyword>anti-VEGF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Edema</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT04455399
org study id: 20200102
nct id: NCT04455399
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency
      and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique
      using a dual blade speculum among patients undergoing IVI for various indications.
Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and
      safety of a single-use IIG with a traditional technique using a dual blade speculum among
      patients undergoing IVI for various indications.

      The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for
      neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV),
      diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane
      from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history
      of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral
      thinning, history of previous glaucoma surgery, history of pars plana vitrectomy,
      hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand
      the informed consent form.

      The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal
      injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random
      number generator will be used to generate an odd or even number for each eye. Odd eyes will
      be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection,
      once the first eye is randomized to one technique, the second eye will be automatically
      assigned to the other technique. The study will be conducted in compliance with the
      Declaration of Helsinki. All patients will provide informed consent prior to start of study
      procedures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of intravitreal injection procedure
time frame: At time of injection procedure
description: Duration in seconds from application to removal of single-blade or dual blade speculum
measure: Adverse event rate
time frame: Immediately and up to 1 month after the intravitreal injection procedure
description: Frequency of adverse events and serious adverse events after intravitreal injection
measure: Patient preference for IVI technique
time frame: Immediately post injection using single-blade speculum
description: Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum
arm group label: Intravitreal injection guide
arm group type: Other
description: Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye
arm group label: Dual blade eyelid speculum
arm group type: Other
description: Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus
intervention type: Device
intervention name: Intravitreal injection guide (Malosa)
description: A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion
arm group label: Intravitreal injection guide
other name: Malosa intravitreal injection guide
intervention type: Device
intervention name: Dual Blade Eyelid Speculum
description: A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.
arm group label: Dual blade eyelid speculum
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Harvey S Uy, MD
role: Principal Investigator
affiliation: Peregrine Eye and Laser Institute
facility: 
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: Macular Degeneration
mesh term: Macular Edema
mesh term: Retinal Vein Occlusion
mesh term: Choroidal Neovascularization
mesh term: Edema
mesh term: Neovascularization, Pathologic
sharing ipd: No