<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/NCT03800589</url>
  </required_header>
  <id_info>
    <org_study_id>15/WIM/2010</org_study_id>
    <nct_id>NCT03800589</nct_id>
  </id_info>
  <brief_title>Assessment of Effectiveness Ex-Press Surgery Modification</brief_title>
  <official_title>Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Institute od Medicine National Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Military Institute od Medicine National Research Institute</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>
      The purpose of the study is to compare the effectiveness and safety profile of ExPress&#xD;
      implantation versus partial deep sclerectomy combined with ExPress implantation with&#xD;
      simultaneously phacoemulsification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep&#xD;
      sclerectomy (DS) with ExPress device implantation. The goal of this modification was to&#xD;
      enhance hypotensive effect of well known procedure, and also to simplify non-penetrating&#xD;
      surgery, which is a procedure with a long learning curve. Mermoud's idea provides the&#xD;
      possibility of avoiding complications related to dissection of the filtering bleb and gives&#xD;
      hope for achieve of better results in comparison to the classical procedure. Thanks to this,&#xD;
      the surgical procedure could be performed earlier, even in the case of glaucoma with low&#xD;
      intraocular pressure (IOP), where vascular factors are largely responsible for the&#xD;
      progression of neuropathy. To demonstrate the potential of both types of procedures with the&#xD;
      application of the ExPress implant, the authors decided to conduct a prospective, randomized&#xD;
      study with a 2-year observation period concerning the efficacy, safety and stability of&#xD;
      effects achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2010</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</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>
    <intervention_model_description>Prospective, randomized control study with 24-month follow-up.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP</measure>
    <time_frame>baseline, and 24th month after surgery</time_frame>
    <description>the change in level of intraocular pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CDVA</measure>
    <time_frame>baseline, and 24th month after surgery</time_frame>
    <description>the change in corrected distance visual acuity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of drugs</measure>
    <time_frame>baseline, and 24th month after surgery</time_frame>
    <description>the change in number of antiglaucoma medications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of complications</measure>
    <time_frame>in a day of surgery</time_frame>
    <description>rate of complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <condition>Glaucoma Secondary</condition>
  <condition>Glaucoma, Primary Open Angle</condition>
  <arm_group>
    <arm_group_label>phaco and Ex-Press</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press</description>
  </arm_group>
  <arm_group>
    <arm_group_label>deep sclerectomy, phaco and Ex-press</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>phacoemulsification with implantation of the Ex-Press</intervention_name>
    <description>The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.</description>
    <arm_group_label>phaco and Ex-Press</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>deep sclerectomy, phacoemulsification, ExPress implantation</intervention_name>
    <description>The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.</description>
    <arm_group_label>deep sclerectomy, phaco and Ex-press</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale&#xD;
&#xD;
          -  patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and&#xD;
             normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved&#xD;
             despite maximum tolerable hypotensive treatment, both topical and systemic,&#xD;
&#xD;
          -  documented progression of loss of field of vision,&#xD;
&#xD;
          -  significant daily IOP fluctuations,&#xD;
&#xD;
          -  no cooperation from patient with regard to application of anti-glaucoma treatment,&#xD;
&#xD;
          -  allergy to topical medication&#xD;
&#xD;
          -  written consent to involvement and participation in the study for a period of at least&#xD;
             24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent to participation in the study&#xD;
&#xD;
          -  prior surgical and laser procedures in the area of the eye&#xD;
&#xD;
          -  narrow- or closed-angle glaucoma&#xD;
&#xD;
          -  post-inflammatory or post-traumatic secondary glaucoma&#xD;
&#xD;
          -  chronic illness of the cornea or optic nerve&#xD;
&#xD;
          -  advanced macular degeneration&#xD;
&#xD;
          -  active inflammatory process&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  systemic steroid therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marek Rękas, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Military Institute of Medicine in Warsaw</affiliation>
  </overall_official>
  <results_reference>
    <citation>Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.</citation>
    <PMID>20552258</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</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>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 18 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement</ipd_access_criteria>
  </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/NCT03800589
org study id: 15/WIM/2010
nct id: NCT03800589
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to compare the effectiveness and safety profile of ExPress
      implantation versus partial deep sclerectomy combined with ExPress implantation with
      simultaneously phacoemulsification.
Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep
      sclerectomy (DS) with ExPress device implantation. The goal of this modification was to
      enhance hypotensive effect of well known procedure, and also to simplify non-penetrating
      surgery, which is a procedure with a long learning curve. Mermoud's idea provides the
      possibility of avoiding complications related to dissection of the filtering bleb and gives
      hope for achieve of better results in comparison to the classical procedure. Thanks to this,
      the surgical procedure could be performed earlier, even in the case of glaucoma with low
      intraocular pressure (IOP), where vascular factors are largely responsible for the
      progression of neuropathy. To demonstrate the potential of both types of procedures with the
      application of the ExPress implant, the authors decided to conduct a prospective, randomized
      study with a 2-year observation period concerning the efficacy, safety and stability of
      effects achieved.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized control study with 24-month follow-up.
primary purpose: Treatment
masking: None (Open Label)
measure: IOP
time frame: baseline, and 24th month after surgery
description: the change in level of intraocular pressure
measure: CDVA
time frame: baseline, and 24th month after surgery
description: the change in corrected distance visual acuity
measure: number of drugs
time frame: baseline, and 24th month after surgery
description: the change in number of antiglaucoma medications
measure: number of complications
time frame: in a day of surgery
description: rate of complications
arm group label: phaco and Ex-Press
arm group type: Active Comparator
description: patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press
arm group label: deep sclerectomy, phaco and Ex-press
arm group type: Active Comparator
description: patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation
intervention type: Procedure
intervention name: phacoemulsification with implantation of the Ex-Press
description: The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.
arm group label: phaco and Ex-Press
intervention type: Procedure
intervention name: deep sclerectomy, phacoemulsification, ExPress implantation
description: The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.
arm group label: deep sclerectomy, phaco and Ex-press
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marek Rękas, Prof
role: Principal Investigator
affiliation: Military Institute of Medicine in Warsaw
citation: Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.
PMID: 20552258
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 18 months of study completion
ipd access criteria: Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement