<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/NCT04503356</url>
  </required_header>
  <id_info>
    <org_study_id>44/PB/2018</org_study_id>
    <nct_id>NCT04503356</nct_id>
  </id_info>
  <brief_title>OMNI in Open-angle Glaucoma Treatment</brief_title>
  <official_title>Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre of Postgraduate Medical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre of Postgraduate Medical Education</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single-center, prospective study will assess safety and effectiveness of 360 degree&#xD;
      viscodilation followed by up to 360 degree trabeculotomy used in patients with early or&#xD;
      moderate open-angle glaucoma in a real-world setting either as a standalone procedure in&#xD;
      pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.&#xD;
&#xD;
      Medication usage, IOP and secondary surgical procedures necessary for IOP control will be&#xD;
      analyzed during the follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 17, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>To prospectively assess the clinical effect of ab-interno transluminal viscodilation and trabeculotomy performed using the OMNI Surgical System as a standalone procedure or in combination with cataract extraction on intraocular pressure (IOP) and the use of ocular hypotensive medications in patients with open-angle glaucoma (OAG).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants wih Postoperative complications</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <condition>Cataract</condition>
  <condition>Eye Diseases</condition>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>OMNI as a standalone procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>OMNI combined with cataract surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OMNI as a standalone procedure</intervention_name>
    <description>It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure.</description>
    <arm_group_label>OMNI as a standalone procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OMNI combined with cataract surgery</intervention_name>
    <description>Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System.</description>
    <arm_group_label>OMNI combined with cataract surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma&#xD;
&#xD;
          -  0-3 topical ocular hypotensive medications at preoperative baseline. Fixed&#xD;
             combinations counted as number of components&#xD;
&#xD;
          -  Open angles (Shaffer grade ≥3)&#xD;
&#xD;
          -  early or moderate glaucoma (based on visual field)&#xD;
&#xD;
          -  Subjects with a combined procedure should have had uncomplicated cataract surgery&#xD;
             (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence&#xD;
             of zonular dehiscence or rupture, well centered IOL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following prior treatments for glaucoma:&#xD;
&#xD;
               -  Suprachoroidal stent&#xD;
&#xD;
               -  Laser trabeculoplasty ≤6 months prior to OMNI procedure&#xD;
&#xD;
               -  Trabecular bypass implanted ≤6 months prior to OMNI procedure&#xD;
&#xD;
               -  Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma&#xD;
                  draining device/valve&#xD;
&#xD;
               -  Prior canaloplasty, goniotomy, or trabeculotomy&#xD;
&#xD;
          -  Forms of glaucoma other than OAG including: acute angle closure, traumatic,&#xD;
             congenital, malignant, uveitic or neovascular glaucoma&#xD;
&#xD;
          -  Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit&#xD;
&#xD;
          -  Clinically significant ocular pathology, other than age-related cataract and glaucoma.&#xD;
             (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic&#xD;
             neuritis in medical history)&#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>Iwona Grabska-Liberek, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orlowski Hospital, Centre of Postgraduate Medical Education</name>
      <address>
        <city>Warsaw</city>
        <zip>00-401</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre of Postgraduate Medical Education</investigator_affiliation>
    <investigator_full_name>Iwona Grabska- Liberek</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>open-angle glaucoma</keyword>
  <keyword>cataract</keyword>
  <keyword>glaucoma surgery</keyword>
  <keyword>ophthalmology</keyword>
  <keyword>OMNI</keyword>
  <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>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Eye Diseases</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/NCT04503356
org study id: 44/PB/2018
nct id: NCT04503356
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This single-center, prospective study will assess safety and effectiveness of 360 degree
      viscodilation followed by up to 360 degree trabeculotomy used in patients with early or
      moderate open-angle glaucoma in a real-world setting either as a standalone procedure in
      pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.

      Medication usage, IOP and secondary surgical procedures necessary for IOP control will be
      analyzed during the follow-up period.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: To prospectively assess the clinical effect of ab-interno transluminal viscodilation and trabeculotomy performed using the OMNI Surgical System as a standalone procedure or in combination with cataract extraction on intraocular pressure (IOP) and the use of ocular hypotensive medications in patients with open-angle glaucoma (OAG).
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline
time frame: 1 year
measure: Number of Participants wih Postoperative complications
time frame: 1 year
arm group label: OMNI as a standalone procedure
arm group type: Active Comparator
arm group label: OMNI combined with cataract surgery
arm group type: Active Comparator
intervention type: Procedure
intervention name: OMNI as a standalone procedure
description: It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure.
arm group label: OMNI as a standalone procedure
intervention type: Procedure
intervention name: OMNI combined with cataract surgery
description: Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System.
arm group label: OMNI combined with cataract surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iwona Grabska-Liberek, MD, PhD
role: Principal Investigator
affiliation: Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Centre of Postgraduate Medical Education
investigator full name: Iwona Grabska- Liberek
investigator title: Professor
mesh term: Glaucoma
mesh term: Cataract
mesh term: Glaucoma, Open-Angle
mesh term: Eye Diseases