<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/NCT03255785</url>
  </required_header>
  <id_info>
    <org_study_id>GCF-040</org_study_id>
    <nct_id>NCT03255785</nct_id>
  </id_info>
  <brief_title>Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra</brief_title>
  <official_title>A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glaukos Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glaukos Corporation</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular&#xD;
      micro-bypass stent and one suprachoroidal stent&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">December 3, 2019</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</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>iStent and iStent Supra</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>IOP outcome masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>20% IOP reduction from baseline</measure>
    <time_frame>Month 12</time_frame>
    <description>IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IOP less than or equal to 18 mm Hg</measure>
    <time_frame>Month 12</time_frame>
    <description>IOP measured via Goldmann tonometry in mm Hg</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>G1 plus G3 with phaco</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cataract surgery plus one iStent and one iStent Supra implanted</intervention_name>
    <description>Cataract surgery via phacoemulsfication plus one iStent and one iStent supra</description>
    <arm_group_label>G1 plus G3 with phaco</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically significant cataract requiring surgery Primary open-angle or&#xD;
             pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two&#xD;
             ocular hypotensive medications at screening Medicated IOP at screening between 18 and&#xD;
             30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent&#xD;
             implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye&#xD;
             Traumatic, uveitic, or neovascular glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Glaukos Investigator Sites</name>
      <address>
        <city>Yerevan</city>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2022</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>Cataract</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</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/NCT03255785
org study id: GCF-040
nct id: NCT03255785
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular
      micro-bypass stent and one suprachoroidal stent
allocation: N/A
intervention model: Single Group Assignment
intervention model description: iStent and iStent Supra
primary purpose: Treatment
masking: None (Open Label)
masking description: IOP outcome masked
measure: 20% IOP reduction from baseline
time frame: Month 12
description: IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP
measure: IOP less than or equal to 18 mm Hg
time frame: Month 12
description: IOP measured via Goldmann tonometry in mm Hg
arm group label: G1 plus G3 with phaco
arm group type: Experimental
description: Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra
intervention type: Device
intervention name: Cataract surgery plus one iStent and one iStent Supra implanted
description: Cataract surgery via phacoemulsfication plus one iStent and one iStent supra
arm group label: G1 plus G3 with phaco
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Armenia
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Cataract
mesh term: Glaucoma, Open-Angle
sharing ipd: No