<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/NCT04503590</url>
  </required_header>
  <id_info>
    <org_study_id>CL-20-01</org_study_id>
    <nct_id>NCT04503590</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study</brief_title>
  <official_title>Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanoculis Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanoculis Ltd</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>
      Eligible Glaucoma patients will undergo pre-surgery examination including:&#xD;
&#xD;
      medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be&#xD;
      measured. Then a sub-conjunctival injection of Mitomycin C will be administered .&#xD;
&#xD;
      The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage&#xD;
      channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] .&#xD;
      MIMS procedure may be combined with cataract surgery.&#xD;
&#xD;
      Patients will be followed up to 52 weeks post operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure.&#xD;
&#xD;
      Description of MIMS procedure:&#xD;
&#xD;
      on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival&#xD;
      injection of Mitomycin C will be administered .&#xD;
&#xD;
      creating drainage channel at the sclera-corneal junction by penetrating through the wall&#xD;
      [scleral tissue]. MIMS procedure may be combined with cataract surgery.&#xD;
&#xD;
      Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least&#xD;
      one month.&#xD;
&#xD;
      Patients will be followed up to 52 weeks post operation.&#xD;
&#xD;
      The following measurements will be included:&#xD;
&#xD;
        -  Intra Ocular Pressure (IOP)&#xD;
&#xD;
        -  Best Corrected Visual Acuity (BCVA)&#xD;
&#xD;
        -  Slit Lamp Biomicroscopic evaluation&#xD;
&#xD;
        -  Anterior Segment Optical coherence tomography (OCT)&#xD;
&#xD;
        -  Fundus Examination&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2019</start_date>
  <completion_date type="Actual">August 11, 2022</completion_date>
  <primary_completion_date type="Actual">August 11, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular Pressure Reduction</measure>
    <time_frame>52 weeks</time_frame>
    <description>Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or less number of medications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Intraocular Pressure</measure>
    <time_frame>52 weeks</time_frame>
    <description>Mean change in IOP from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event</measure>
    <time_frame>52 weeks</time_frame>
    <description>Incidence of adverse events related to MIMS® device/procedure, throughout the study follow-up</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Minimally invasive micro sclerostomy (MIMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>create a drainage channel at the sclera-corneal junction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Minimally Invasive Micro Sclerostomy (MIMS)</intervention_name>
    <description>The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.</description>
    <arm_group_label>Minimally invasive micro sclerostomy (MIMS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 18 years&#xD;
&#xD;
          -  Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the&#xD;
             study eye&#xD;
&#xD;
          -  Optic nerve appearance characteristic of glaucoma in the study eye&#xD;
&#xD;
          -  Patient is treated with 0 to 5 hypotensive medications in the study eye&#xD;
&#xD;
          -  Unsatisfactory IOP (≥ 21 mmHg) at the screening visit in the study eye&#xD;
&#xD;
          -  If cataract is not present - Shaffer grade ≥ III in all four angle quadrants in the&#xD;
             study eye&#xD;
&#xD;
          -  Subject is able and willing to attend all scheduled follow-up exams&#xD;
&#xD;
          -  Subject understands and signs the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ocular conditions with a poorer prognosis in the fellow eye than in the study eye&#xD;
&#xD;
          -  Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery&#xD;
             immediately prior to the MIMS procedure or the study eye is pseudophakic with PCIOL.&#xD;
&#xD;
          -  Congenital or developmental glaucoma in either eye&#xD;
&#xD;
          -  Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced,&#xD;
             or glaucoma associated with increased episcleral venous pressure) in the study eye&#xD;
&#xD;
          -  Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the&#xD;
             study eye&#xD;
&#xD;
          -  Subject has history of penetrating keratoplasty (PKP)&#xD;
&#xD;
          -  Any previous surgery in the study eye (except for clear corneal cataract surgery)&#xD;
             where the conjunctiva is not intact and elastic.&#xD;
&#xD;
          -  Any ocular disease or history in study eye such as severe dry eye, active&#xD;
             proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular&#xD;
             pathology that may interfere with accurate IOP measurements&#xD;
&#xD;
          -  Prior surgery for an ab-interno or ab-externo device implanted in or through the&#xD;
             Schlemm's canal in the study eye.&#xD;
&#xD;
          -  Use of oral hypotensive medication for glaucoma for treatment of the fellow eye&#xD;
&#xD;
          -  Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye&#xD;
&#xD;
          -  History of idiopathic or autoimmune uveitis in either eye&#xD;
&#xD;
          -  Severe trauma in study eye&#xD;
&#xD;
          -  Active iris neovascularization, previous cyclodestructive procedure, prior scleral&#xD;
             buckling procedure, presence of silicone oil&#xD;
&#xD;
          -  Vitreous present in anterior chamber, prior vitrectomy or virteous hemorrhage in study&#xD;
             eye&#xD;
&#xD;
          -  Aphakia&#xD;
&#xD;
          -  Prior vitreoretinal surgery in study eye&#xD;
&#xD;
          -  Clinically significant ocular inflammation or infection within 90 days prior to&#xD;
             screening&#xD;
&#xD;
          -  Unable to discontinue use of blood thinners in accordance with surgeon's standard&#xD;
             preoperative instructions&#xD;
&#xD;
          -  Uncontrolled systemic disease that in the opinion of the investigator would put the&#xD;
             subject's health at risk and/or prevent the subject from completing all study visits&#xD;
&#xD;
          -  Current participation or participation in another investigational drug or device&#xD;
             clinical trial within the last 30 days before screening visit&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>S.V.Malayan'S Eye Center</name>
      <address>
        <city>Yerevan</city>
        <zip>0048</zip>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
  </location_countries>
  <verification_date>November 2022</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>November 27, 2022</last_update_submitted>
  <last_update_submitted_qc>November 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04503590
org study id: CL-20-01
nct id: NCT04503590
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Eligible Glaucoma patients will undergo pre-surgery examination including:

      medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be
      measured. Then a sub-conjunctival injection of Mitomycin C will be administered .

      The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage
      channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] .
      MIMS procedure may be combined with cataract surgery.

      Patients will be followed up to 52 weeks post operation.
Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure.

      Description of MIMS procedure:

      on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival
      injection of Mitomycin C will be administered .

      creating drainage channel at the sclera-corneal junction by penetrating through the wall
      [scleral tissue]. MIMS procedure may be combined with cataract surgery.

      Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least
      one month.

      Patients will be followed up to 52 weeks post operation.

      The following measurements will be included:

        -  Intra Ocular Pressure (IOP)

        -  Best Corrected Visual Acuity (BCVA)

        -  Slit Lamp Biomicroscopic evaluation

        -  Anterior Segment Optical coherence tomography (OCT)

        -  Fundus Examination
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intraocular Pressure Reduction
time frame: 52 weeks
description: Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or less number of medications
measure: Mean Intraocular Pressure
time frame: 52 weeks
description: Mean change in IOP from baseline
measure: Adverse Event
time frame: 52 weeks
description: Incidence of adverse events related to MIMS® device/procedure, throughout the study follow-up
arm group label: Minimally invasive micro sclerostomy (MIMS)
arm group type: Experimental
description: create a drainage channel at the sclera-corneal junction
intervention type: Device
intervention name: Minimally Invasive Micro Sclerostomy (MIMS)
description: The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.
arm group label: Minimally invasive micro sclerostomy (MIMS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Armenia
responsible party type: Sponsor
mesh term: Glaucoma
sharing ipd: No