<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/NCT04468633</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00105781</org_study_id>
    <nct_id>NCT04468633</nct_id>
  </id_info>
  <brief_title>The Baerveldt Versus ClearPath Comparison Study</brief_title>
  <official_title>The Baerveldt Versus ClearPath Comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized prospective study of post-operative surgical outcomes and complication&#xD;
      rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject&#xD;
      will be randomized to the Baerveldt group or ClearPath group at the time of consent for the&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2020</start_date>
  <completion_date type="Actual">June 29, 2023</completion_date>
  <primary_completion_date type="Actual">June 29, 2023</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intraocular pressure (IOP)</measure>
    <time_frame>Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Week 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Week 6</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Month 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Month 6</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Year 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Best corrected visual acuity (BCVA)</measure>
    <time_frame>Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of individual eyedrop medications that the patient is on (prescribed and actually taking)</measure>
    <time_frame>Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Slit lamp exam (SLE) findings</measure>
    <time_frame>Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dilated fundus exam (DFE)</measure>
    <time_frame>Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Humphrey visual field (HVF)</measure>
    <time_frame>Baseline and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ocular coherence tomography (OCT)</measure>
    <time_frame>Baseline and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pachymetry</measure>
    <time_frame>Baseline and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motility exam (9 gaze photos)</measure>
    <time_frame>Baseline and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motility exam (stereo test)</measure>
    <time_frame>Baseline and Year 1</time_frame>
    <description>If patient is binocular</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motility exam (Worth 4-dot)</measure>
    <time_frame>Baseline and Year 1</time_frame>
    <description>If patient is binocular</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motility exam (Hess Screen Test)</measure>
    <time_frame>Baseline and Year 1</time_frame>
    <description>If patient is binocular</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-report Dysesthesia Scale questionnaire</measure>
    <time_frame>Baseline and Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life, as measured by glaucoma utility index</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life, as measured by glaucoma symptom scale</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life, as measured by glaucoma related quality of life 15 questionnaire</measure>
    <time_frame>Year 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Baerveldt 350 implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ahmed ClearPath 350 implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Baerveldt 350 implant</intervention_name>
    <description>The Baerveldt implant is an FDA-approved silicone, non-valved implant.</description>
    <arm_group_label>Baerveldt 350 implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ahmed ClearPath 350 implant</intervention_name>
    <description>The Ahmed ClearPath is a non-valved glaucoma drainage device.</description>
    <arm_group_label>Ahmed ClearPath 350 implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women with age at screening ≥ 18 years and ≤ 90 years&#xD;
&#xD;
          -  Inadequately controlled glaucoma&#xD;
&#xD;
          -  Valve-less aqueous shunt as the planned surgical procedure&#xD;
&#xD;
          -  Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic&#xD;
             glaucoma with a previous failed trabeculectomy or other intraocular surgery included.&#xD;
&#xD;
          -  Primary tubes included&#xD;
&#xD;
          -  Investigators to recruit consecutively all eligible patients from their clinics.&#xD;
&#xD;
          -  Superotemporal or inferonasal placement of the tube&#xD;
&#xD;
          -  Capable and willing to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NLP&#xD;
&#xD;
          -  Unable/unwilling to provide informed consent&#xD;
&#xD;
          -  Unavailable for regular follow up&#xD;
&#xD;
          -  Previous cyclodestructive procedure&#xD;
&#xD;
          -  Prior scleral buckling procedure or other external impediment to supratemporal&#xD;
             drainage device implantation&#xD;
&#xD;
          -  Presence of silicone oil&#xD;
&#xD;
          -  Vitreous in the anterior chamber sufficient to require a vitrectomy&#xD;
&#xD;
          -  Uveitic glaucoma&#xD;
&#xD;
          -  Neovascular glaucoma&#xD;
&#xD;
          -  Nanophthalmos&#xD;
&#xD;
          -  Sturge-Weber syndrome or other conditions associated with elevated episcleral venous&#xD;
             pressure&#xD;
&#xD;
          -  Procedure combined with other surgery&#xD;
&#xD;
          -  Any abnormality other than glaucoma in the study eye that could affect tonometry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leon Herndon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Eye Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Baerveldt 350 implant</keyword>
  <keyword>Ahmed ClearPath implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT04468633
org study id: PRO00105781
nct id: NCT04468633
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a randomized prospective study of post-operative surgical outcomes and complication
      rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject
      will be randomized to the Baerveldt group or ClearPath group at the time of consent for the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in intraocular pressure (IOP)
time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Complication rate
time frame: Baseline
measure: Complication rate
time frame: Day 1
measure: Complication rate
time frame: Week 1
measure: Complication rate
time frame: Week 4
measure: Complication rate
time frame: Week 6
measure: Complication rate
time frame: Month 3
measure: Complication rate
time frame: Month 6
measure: Complication rate
time frame: Year 1
measure: Change in Best corrected visual acuity (BCVA)
time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Change in number of individual eyedrop medications that the patient is on (prescribed and actually taking)
time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Change in Slit lamp exam (SLE) findings
time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Change in Dilated fundus exam (DFE)
time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Change in Humphrey visual field (HVF)
time frame: Baseline and Year 1
measure: Change in Ocular coherence tomography (OCT)
time frame: Baseline and Year 1
measure: Change in Pachymetry
time frame: Baseline and Year 1
measure: Change in Motility exam (9 gaze photos)
time frame: Baseline and Year 1
measure: Change in Motility exam (stereo test)
time frame: Baseline and Year 1
description: If patient is binocular
measure: Change in Motility exam (Worth 4-dot)
time frame: Baseline and Year 1
description: If patient is binocular
measure: Change in Motility exam (Hess Screen Test)
time frame: Baseline and Year 1
description: If patient is binocular
measure: Change in Self-report Dysesthesia Scale questionnaire
time frame: Baseline and Year 1
measure: Quality of life, as measured by glaucoma utility index
time frame: Year 1
measure: Quality of life, as measured by glaucoma symptom scale
time frame: Year 1
measure: Quality of life, as measured by glaucoma related quality of life 15 questionnaire
time frame: Year 1
arm group label: Baerveldt 350 implant
arm group type: Active Comparator
arm group label: Ahmed ClearPath 350 implant
arm group type: Active Comparator
intervention type: Device
intervention name: Baerveldt 350 implant
description: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
arm group label: Baerveldt 350 implant
intervention type: Device
intervention name: Ahmed ClearPath 350 implant
description: The Ahmed ClearPath is a non-valved glaucoma drainage device.
arm group label: Ahmed ClearPath 350 implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Leon Herndon, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
sharing ipd: No