<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/NCT04440527</url>
  </required_header>
  <id_info>
    <org_study_id>PAINT-Study</org_study_id>
    <nct_id>NCT04440527</nct_id>
  </id_info>
  <brief_title>Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy</brief_title>
  <acronym>PAINT</acronym>
  <official_title>Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</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>
      The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in&#xD;
      patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the&#xD;
      reduction of intraocular pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority&#xD;
      study of glaucoma patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 22, 2020</start_date>
  <completion_date type="Anticipated">July 22, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 22, 2022</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in intraocular pressure</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <condition>Pseudoexfoliation Glaucoma</condition>
  <arm_group>
    <arm_group_label>Microshunt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trabeculectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated with trabeculectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Preserflo / Innfocus Microshunt</intervention_name>
    <description>The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.</description>
    <arm_group_label>Microshunt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trabeculectomy</intervention_name>
    <description>Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.</description>
    <arm_group_label>Trabeculectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Primary open angle glaucoma or pseudoexfoliation glaucoma&#xD;
&#xD;
          -  medically uncontrollable intraocular pressure or intolerance of topical therapy&#xD;
&#xD;
          -  negative urine/serum pregnancy test of women in childbearing age&#xD;
&#xD;
          -  signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous incisional glaucoma procedure on affected eye&#xD;
&#xD;
          -  pregnancy, nursing period&#xD;
&#xD;
          -  Patients in military service, training periods and civil service&#xD;
&#xD;
          -  Participation in another clinical trail&#xD;
&#xD;
          -  pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva&#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_contact>
    <last_name>Teresa Rauchegger, Dr.</last_name>
    <phone>+43 512 504 24184</phone>
    <email>teresa.rauchegger@i-med.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barbara Teuchner, Dr.</last_name>
    <phone>+43 512 504 24184</phone>
    <email>barbara.teuchner@i-med.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Exfoliation Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04440527
org study id: PAINT-Study
nct id: NCT04440527
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in
      patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the
      reduction of intraocular pressure.
The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority
      study of glaucoma patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Difference in intraocular pressure
time frame: 1 year
description: The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
arm group label: Microshunt
arm group type: Experimental
description: Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).
arm group label: Trabeculectomy
arm group type: Active Comparator
description: Patients will be treated with trabeculectomy.
intervention type: Device
intervention name: Preserflo / Innfocus Microshunt
description: The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
arm group label: Microshunt
intervention type: Other
intervention name: Trabeculectomy
description: Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
arm group label: Trabeculectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Teresa Rauchegger, Dr.
phone: +43 512 504 24184
email: teresa.rauchegger@i-med.ac.at
last name: Barbara Teuchner, Dr.
phone: +43 512 504 24184
email: barbara.teuchner@i-med.ac.at
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Exfoliation Syndrome
sharing ipd: Undecided