<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/NCT02196584</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00021075</org_study_id>
    <nct_id>NCT02196584</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the RAVI-Guide</brief_title>
  <official_title>Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid&#xD;
      speculum during intravitreal injections&#xD;
&#xD;
      Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with&#xD;
      those of the conventional lid speculum and caliper approach&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain severity associated with instrument type used for holding eyelids open during intravitreal injection</measure>
    <time_frame>Within 15 minutes of injection procedure</time_frame>
    <description>A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural complications associated with instrument use during intravitreal injection procedure</measure>
    <time_frame>Within 15 minutes of injection procedure</time_frame>
    <description>A questionnaire that queries about procedural complications will be completed by the treating physician.</description>
  </secondary_outcome>
  <enrollment type="Actual">55</enrollment>
  <condition>Retinal Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients 18 years of age or older who undergo intravitreal injection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 years or older who undergo intravitreal injection for clinical&#xD;
             indications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 years&#xD;
&#xD;
          -  Patients unable to give informed consent&#xD;
&#xD;
          -  Disorders that preclude the ability to judge pain or discomfort associated with&#xD;
             intravitreal injection&#xD;
&#xD;
          -  Disorders that preclude the ability to assess for complications of intravitreal&#xD;
             injection&#xD;
&#xD;
          -  Inability to assess the landmarks by which localization of intravitreal injection&#xD;
             sites is determined, such as obscured corneal limbus&#xD;
&#xD;
          -  Inability to communicate directly to the physician and immediately after the procedure&#xD;
             the level of pain or discomfort&#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>Dennis P Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Froedtert and Medical College of Wisconsin Eye Institute</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 22, 2016</last_update_submitted>
  <last_update_submitted_qc>June 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Dennis Han</investigator_full_name>
    <investigator_title>Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02196584
org study id: PRO00021075
nct id: NCT02196584
lead sponsor: 
has dmc: No
Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid
      speculum during intravitreal injections

      Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with
      those of the conventional lid speculum and caliper approach
observational model: Case-Control
time perspective: Prospective
measure: Pain severity associated with instrument type used for holding eyelids open during intravitreal injection
time frame: Within 15 minutes of injection procedure
description: A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity.
measure: Procedural complications associated with instrument use during intravitreal injection procedure
time frame: Within 15 minutes of injection procedure
description: A questionnaire that queries about procedural complications will be completed by the treating physician.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dennis P Han, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Dennis Han
investigator title: Professor of Ophthalmology
mesh term: Retinal Diseases