<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/NCT02260219</url>
  </required_header>
  <id_info>
    <org_study_id>GL-12-01</org_study_id>
    <nct_id>NCT02260219</nct_id>
  </id_info>
  <brief_title>Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma</brief_title>
  <official_title>Comparative Study of the Safety and Efficacy of the Ahmed Glaucoma Valve Drainage Device, Model M4 (High Density Porous Polyethylene) and the Model S2 (Polypropylene) in Patients With Neovascular Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asociación para Evitar la Ceguera en México</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asociación para Evitar la Ceguera en México</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage&#xD;
      Device, model M4 compared with the model S2.&#xD;
&#xD;
      Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group&#xD;
      (M4 and S2). They will be operated using conventional techniques and creating a&#xD;
      sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be&#xD;
      monitoring for one year and the results will be evaluated with respect to a postoperative&#xD;
      reduction in pressure, changes in visual acuity, the need for drugs and complications, in&#xD;
      addition to the demographic characteristics of each group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <primary_completion_date type="Actual">February 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse effects</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Neovascular Glaucoma</condition>
  <arm_group>
    <arm_group_label>S2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgically Implant an Ahmed Glaucoma Drainage Device Model S2 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgically Implant an Ahmed Glaucoma Drainage Device Model M4 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2</intervention_name>
    <description>Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP</description>
    <arm_group_label>M4</arm_group_label>
    <arm_group_label>S2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of Neovascular glaucoma&#xD;
&#xD;
          -  High IOP despite topical treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Mental disorders&#xD;
&#xD;
          -  Previous glaucoma surgery&#xD;
&#xD;
          -  Patients older than 18 years&#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>Felix Gil-Carrasco, MD</last_name>
    <role>Study Director</role>
    <affiliation>52 55 10841400</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ahmed implant</keyword>
  <keyword>Neovascular Glaucoma</keyword>
  <keyword>Intraocular pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Neovascular</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/NCT02260219
org study id: GL-12-01
nct id: NCT02260219
lead sponsor: 
has dmc: No
Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage
      Device, model M4 compared with the model S2.

      Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group
      (M4 and S2). They will be operated using conventional techniques and creating a
      sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be
      monitoring for one year and the results will be evaluated with respect to a postoperative
      reduction in pressure, changes in visual acuity, the need for drugs and complications, in
      addition to the demographic characteristics of each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse effects
time frame: 1 year
measure: Intraocular pressure
time frame: 1 year
arm group label: S2
arm group type: Active Comparator
description: Surgically Implant an Ahmed Glaucoma Drainage Device Model S2 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP
arm group label: M4
arm group type: Active Comparator
description: Surgically Implant an Ahmed Glaucoma Drainage Device Model M4 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP
intervention type: Procedure
intervention name: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
description: Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP
arm group label: M4
arm group label: S2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Felix Gil-Carrasco, MD
role: Study Director
affiliation: 52 55 10841400
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Neovascular