<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/NCT03293251</url>
  </required_header>
  <id_info>
    <org_study_id>1111</org_study_id>
    <nct_id>NCT03293251</nct_id>
  </id_info>
  <brief_title>Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors</brief_title>
  <official_title>Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Queen Elizabeth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</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>
      1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with&#xD;
           MMC or not.&#xD;
&#xD;
        2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.&#xD;
&#xD;
        3. recurrence rate of uveitis after glaucoma surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. determine different success rates of trabeculectomy with MMC undergone in QE hospital,&#xD;
           UK.&#xD;
&#xD;
        2. determine different complications and effect of cataract surgery on the outcome of&#xD;
           glaucoma surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 29, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 29, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Success rates</measure>
    <time_frame>5 year period</time_frame>
    <description>IOP less 21 mmHg</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Outcomes of Trabeculectomy With MMC</condition>
  <arm_group>
    <arm_group_label>uveitic/ POAG</arm_group_label>
    <description>Outcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POAG</arm_group_label>
    <description>Outcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trabeculectomy with MMC</intervention_name>
    <description>glaucoma surgeries</description>
    <arm_group_label>POAG</arm_group_label>
    <arm_group_label>uveitic/ POAG</arm_group_label>
    <other_name>I-STENT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        cohort of patient documented on the database system of Queen Elizabeth hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fesh trabeculectomy surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recurrent surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Kamel Soliman, professor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maha Said</name>
      <address>
        <city>Egypt</city>
        <state>Assiut</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 24, 2017</last_update_submitted>
  <last_update_submitted_qc>September 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Maha omar mahmoud said</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>undecided yet</ipd_description>
  </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/NCT03293251
org study id: 1111
nct id: NCT03293251
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with
           MMC or not.

        2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.

        3. recurrence rate of uveitis after glaucoma surgery
1. determine different success rates of trabeculectomy with MMC undergone in QE hospital,
           UK.

        2. determine different complications and effect of cataract surgery on the outcome of
           glaucoma surgery
observational model: Cohort
time perspective: Retrospective
measure: Success rates
time frame: 5 year period
description: IOP less 21 mmHg
arm group label: uveitic/ POAG
description: Outcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma
arm group label: POAG
description: Outcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups
intervention type: Procedure
intervention name: Trabeculectomy with MMC
description: glaucoma surgeries
arm group label: POAG
arm group label: uveitic/ POAG
other name: I-STENT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr Kamel Soliman, professor
role: Study Director
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Maha omar mahmoud said
investigator title: principle investigator
mesh term: Glaucoma
sharing ipd: Undecided
ipd description: undecided yet