<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/NCT04427995</url>
  </required_header>
  <id_info>
    <org_study_id>948</org_study_id>
    <nct_id>NCT04427995</nct_id>
  </id_info>
  <brief_title>Standalone OMNI Surgical System for Open-angle Glaucoma</brief_title>
  <acronym>OMNIgl</acronym>
  <official_title>Standalone OMNI Surgical System for Open-angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iqbal Ahmed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OMNI Medical Services, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Prism Eye Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential&#xD;
      innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™&#xD;
      Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It&#xD;
      combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one&#xD;
      hand held device without the need for additional incisions or extra instrumentation. The&#xD;
      device recently received FDA approval in the United States for certain indications in&#xD;
      ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and&#xD;
      trabeculotomy on glaucoma drop burden and IOP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential&#xD;
      innovative surgical alternatives to help better control intraocular pressure (IOP).1 The&#xD;
      OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which&#xD;
      targets the conventional outflow pathway.2 This device treats the trabecular meshwork,&#xD;
      Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous&#xD;
      outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal,&#xD;
      dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by&#xD;
      stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted&#xD;
      transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach&#xD;
      to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP&#xD;
      lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device&#xD;
      without the need for additional incisions or extra instrumentation. The device recently&#xD;
      received FDA approval in the United States for delivery of small amounts of viscoelastic&#xD;
      fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy&#xD;
      procedures.6 To date, no study has examined the effect of standalone viscodilation and&#xD;
      trabeculotomy on glaucoma drop burden and IOP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    product expired and could not be resupplied&#xD;
  </why_stopped>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lower Intraocular Pressure and medication dependence</measure>
    <time_frame>Postoperative week 1, month 1, month 3, annually</time_frame>
    <description>Change in IOP less than or equal to baseline with a medication reduction to 1 or less or an IOP change of 20% or less from baseline with medication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.</measure>
    <time_frame>1 month post operatively</time_frame>
    <description>Absence of the following complications:&#xD;
1. ) Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia, and/or; 2.) At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, endophthalmitis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>Oen Angle Glaucoma</arm_group_label>
    <description>• Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OMNI surgical system</intervention_name>
    <description>GATT + viscodilation</description>
    <arm_group_label>Oen Angle Glaucoma</arm_group_label>
    <other_name>OMNI surgical systems</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile /&#xD;
             normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40&#xD;
             mmHg on maximum tolerated medical therapy who are either progressing, above IOP&#xD;
             target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes&#xD;
             and previous laser trabeculoplasty will be included.&#xD;
&#xD;
          -  Exclusions: Other forms of glaucoma, prior incisional glaucoma surgery, prior corneal&#xD;
             graft (PKP, DALK, DSAEK, DMEK), Shafer angle grading &lt;2 in 2 or more quadrants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile /&#xD;
             normal pressure open angle glaucoma or combined mechanism glaucoma.&#xD;
&#xD;
          -  An IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing,&#xD;
             above IOP target, or poorly adherent or tolerant to medical therapy.&#xD;
&#xD;
          -  Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other forms of glaucoma,&#xD;
&#xD;
          -  prior incisional glaucoma surgery,&#xD;
&#xD;
          -  prior corneal graft (PKP, DALK, DSAEK, DMEK),&#xD;
&#xD;
          -  Shafer angle grading &lt;2 in 2 or more quadrants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Iqbal Ahmed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prism Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prism Eye Institute</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6H 0J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://omnisurgical.com/.</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173332.pdf</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.</citation>
    <PMID>28237137</PMID>
  </results_reference>
  <results_reference>
    <citation>Francis BA, Akil H, Bert BB. Ab interno Schlemm's Canal Surgery. Dev Ophthalmol. 2017;59:127-146. doi: 10.1159/000458492. Epub 2017 Apr 25.</citation>
    <PMID>28442693</PMID>
  </results_reference>
  <results_reference>
    <citation>Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956.</citation>
    <PMID>29613978</PMID>
  </results_reference>
  <results_reference>
    <citation>Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm's canal for the reduction of IOP via an ab-interno approach. Clin Ophthalmol. 2018 Oct 23;12:2149-2155. doi: 10.2147/OPTH.S177597. eCollection 2018.</citation>
    <PMID>30425450</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Prism Eye Institute</investigator_affiliation>
    <investigator_full_name>Iqbal Ahmed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>Undecided</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/NCT04427995
org study id: 948
nct id: NCT04427995
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential
      innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™
      Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It
      combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one
      hand held device without the need for additional incisions or extra instrumentation. The
      device recently received FDA approval in the United States for certain indications in
      ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and
      trabeculotomy on glaucoma drop burden and IOP.
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential
      innovative surgical alternatives to help better control intraocular pressure (IOP).1 The
      OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which
      targets the conventional outflow pathway.2 This device treats the trabecular meshwork,
      Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous
      outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal,
      dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by
      stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted
      transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach
      to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP
      lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device
      without the need for additional incisions or extra instrumentation. The device recently
      received FDA approval in the United States for delivery of small amounts of viscoelastic
      fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy
      procedures.6 To date, no study has examined the effect of standalone viscodilation and
      trabeculotomy on glaucoma drop burden and IOP.
observational model: Cohort
time perspective: Prospective
measure: Lower Intraocular Pressure and medication dependence
time frame: Postoperative week 1, month 1, month 3, annually
description: Change in IOP less than or equal to baseline with a medication reduction to 1 or less or an IOP change of 20% or less from baseline with medication
measure: Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.
time frame: 1 month post operatively
description: Absence of the following complications:
1. ) Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia, and/or; 2.) At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, endophthalmitis
arm group label: Oen Angle Glaucoma
description: • Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.
intervention type: Device
intervention name: OMNI surgical system
description: GATT + viscodilation
arm group label: Oen Angle Glaucoma
other name: OMNI surgical systems
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 95 Years
last name: Iqbal Ahmed, MD
role: Principal Investigator
affiliation: Prism Eye Institute
facility: 
country: Canada
url: https://omnisurgical.com/.
description: Related Info
url: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173332.pdf
description: Related Info
citation: Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.
PMID: 28237137
citation: Francis BA, Akil H, Bert BB. Ab interno Schlemm's Canal Surgery. Dev Ophthalmol. 2017;59:127-146. doi: 10.1159/000458492. Epub 2017 Apr 25.
PMID: 28442693
citation: Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956.
PMID: 29613978
citation: Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm's canal for the reduction of IOP via an ab-interno approach. Clin Ophthalmol. 2018 Oct 23;12:2149-2155. doi: 10.2147/OPTH.S177597. eCollection 2018.
PMID: 30425450
responsible party type: Sponsor-Investigator
investigator affiliation: Prism Eye Institute
investigator full name: Iqbal Ahmed
investigator title: Principal Investigator
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: Undecided