<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/NCT02209961</url>
  </required_header>
  <id_info>
    <org_study_id>0054-13</org_study_id>
    <nct_id>NCT02209961</nct_id>
  </id_info>
  <brief_title>Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract</brief_title>
  <official_title>To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and&#xD;
      glaucoma surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The occurrence of both glaucoma and clinically relevant cataract in the same individual is a&#xD;
      frequent condition, especially in the elderly population. Besides age, this might be related&#xD;
      to the possible role of antiglaucoma medications in the progression of lens opacity.When both&#xD;
      procedures are required, these can be performed separately or in combination.&#xD;
&#xD;
      Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower&#xD;
      level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.&#xD;
&#xD;
      The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to&#xD;
      trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG.&#xD;
      This procedure would be theoretically more reproducible and simple to perform as well as less&#xD;
      traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at&#xD;
      the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber&#xD;
      to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a&#xD;
      similar way to trabeculectomy. This procedure can be performed on its own or in combination&#xD;
      with phacoemulsification.&#xD;
&#xD;
      This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or&#xD;
      combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and&#xD;
      cataract .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .</measure>
    <time_frame>within one to two years post surgery</time_frame>
    <description>to check the change in intraocular pressure after EX-PRESS shunt implantation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Glaucoma and Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>glaucoma and ocular hypertension</arm_group_label>
    <description>glaucoma and ocular hypertension</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patient with uncontrolled glaucoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - age above 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - congenital glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rana N Hanna, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</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>Ocular Hypertension</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/NCT02209961
org study id: 0054-13
nct id: NCT02209961
lead sponsor: 
has dmc: Yes
A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and
      glaucoma surgery.
The occurrence of both glaucoma and clinically relevant cataract in the same individual is a
      frequent condition, especially in the elderly population. Besides age, this might be related
      to the possible role of antiglaucoma medications in the progression of lens opacity.When both
      procedures are required, these can be performed separately or in combination.

      Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower
      level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.

      The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to
      trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG.
      This procedure would be theoretically more reproducible and simple to perform as well as less
      traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at
      the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber
      to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a
      similar way to trabeculectomy. This procedure can be performed on its own or in combination
      with phacoemulsification.

      This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or
      combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and
      cataract .
observational model: Cohort
time perspective: Prospective
measure: Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .
time frame: within one to two years post surgery
description: to check the change in intraocular pressure after EX-PRESS shunt implantation
arm group label: glaucoma and ocular hypertension
description: glaucoma and ocular hypertension
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Rana N Hanna, M.D
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Cataract
mesh term: Ocular Hypertension