<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/NCT03751254</url>
  </required_header>
  <id_info>
    <org_study_id>Stellaris</org_study_id>
    <nct_id>NCT03751254</nct_id>
  </id_info>
  <brief_title>Comparison of Stellaris Standard Infusion With Stellaris Elite</brief_title>
  <official_title>Comparison of Phacoemulsification Platform Stellaris With Standard Infusion and Stellaris Elite With Pressurised Bottle in Myopic Eyes Concerning Deepening of Anterior Chamber as Measured by Intra-operative OCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</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>
      Clinical performance of phacoemulsification platform Stellaris Elite with standard irrigation&#xD;
      fluid bottles in myopic eyes. Anterior chamber depth and patients comfort will be compared&#xD;
      between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Today phacoemulsification is the most important and safest procedure to perform cataract&#xD;
      surgery. However, there are factors that can increase the risk of complications, one of them&#xD;
      is an intraoperative increase of intraocular pressure (IOP) which may cause choroidal&#xD;
      haemorrhage, capsular block syndrome, or posterior capsular rupture .&#xD;
&#xD;
      Also, more regularly, alterations of IOP provoke sudden changes of the anterior chamber&#xD;
      depth, especially in myopic eyes due to intra-operative inverse irido-capsular block, which&#xD;
      may result in pain or discomfort for the patient. The deepening of the chamber also makes the&#xD;
      surgical maneuvers more challenging in such eyes.&#xD;
&#xD;
      As prevention of such adverse events, it is important to maintain a more or less constant IOP&#xD;
      intraoperatively. To ensure this, the pressure of the irrigation fluid must be adjusted to&#xD;
      the outflow of aqueous humor, usually by adapting the height of the irrigation fluid bottle&#xD;
      (passive fluidics system). As a variable vacuum is produced at the phaco tip to enable the&#xD;
      suction of lens fragments, there often are fluctuations of IOP, therefore the surgeon is&#xD;
      required to constantly adjust the height of the irrigation fluid bottle.&#xD;
&#xD;
      A novel method to relieve the surgeon of this often-distracting task is to use all-in-one&#xD;
      phacoemulsification systems that are able to monitor vacuum flow rates and then adjust the&#xD;
      pressure of the irrigation fluid intraoperatively, also resulting in less fluctuations of IOP&#xD;
      (active fluidics system). This should also result in reduced deepening of the anterior&#xD;
      chamber and less risk of the adverse events as explained above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>12 months</time_frame>
    <description>Anterior chamber depth will be measured using the IOL Master 700. Fluctuations in anterior chamber depth will be compared between the eyes where Stellaris and the contralateral eyes in which the Stellaris Elite platform was used</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients discomfort</measure>
    <time_frame>12 months</time_frame>
    <description>Patients will be asked concerning their discomfort during both cataract surgeries and results will be recorded using an visual analogue scale. In the visual analogue scale 10 means highest discomfort and 1 stands for lowest discomfort.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Myopic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In myopic patients with axial length over 25.0 mm during surgery of the first eye the Stellaris platform will be used and during surgery of the second eye the Stellaris Elite platform will be used</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stellaris Elite</intervention_name>
    <description>The Stellaris and the Stellaris Elite platform will be used in myopic patients (axial length &gt; 25.0 mm) during cataract surgery</description>
    <arm_group_label>Myopic patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age-related cataract in both eyes&#xD;
&#xD;
          -  Scheduled for bilateral cataract surgery&#xD;
&#xD;
          -  Myopic patiens with axial eye length &gt;25.0mm&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Written informed consent prior to recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)&#xD;
&#xD;
          -  Preceded ophthalmic surgery&#xD;
&#xD;
          -  Any ophthalmic abnormality that could compromise the measurements&#xD;
&#xD;
          -  Concurrent participation in another drug or device clinical investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kristina Stjepanek, MD</last_name>
    <phone>01 91021-57564</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julius Hienert, MD</last_name>
    <phone>01 91021-57564</phone>
    <email>office@viros.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS)</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristina Stjepanek, MD</last_name>
      <phone>01 910 21-57564</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Julius Hienert, MD</last_name>
      <phone>01 91021-57564</phone>
      <email>office@viros.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Cataract surgery</keyword>
  <keyword>Phacoemulsification platform</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT03751254
org study id: Stellaris
nct id: NCT03751254
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Clinical performance of phacoemulsification platform Stellaris Elite with standard irrigation
      fluid bottles in myopic eyes. Anterior chamber depth and patients comfort will be compared
      between the two groups.
Today phacoemulsification is the most important and safest procedure to perform cataract
      surgery. However, there are factors that can increase the risk of complications, one of them
      is an intraoperative increase of intraocular pressure (IOP) which may cause choroidal
      haemorrhage, capsular block syndrome, or posterior capsular rupture .

      Also, more regularly, alterations of IOP provoke sudden changes of the anterior chamber
      depth, especially in myopic eyes due to intra-operative inverse irido-capsular block, which
      may result in pain or discomfort for the patient. The deepening of the chamber also makes the
      surgical maneuvers more challenging in such eyes.

      As prevention of such adverse events, it is important to maintain a more or less constant IOP
      intraoperatively. To ensure this, the pressure of the irrigation fluid must be adjusted to
      the outflow of aqueous humor, usually by adapting the height of the irrigation fluid bottle
      (passive fluidics system). As a variable vacuum is produced at the phaco tip to enable the
      suction of lens fragments, there often are fluctuations of IOP, therefore the surgeon is
      required to constantly adjust the height of the irrigation fluid bottle.

      A novel method to relieve the surgeon of this often-distracting task is to use all-in-one
      phacoemulsification systems that are able to monitor vacuum flow rates and then adjust the
      pressure of the irrigation fluid intraoperatively, also resulting in less fluctuations of IOP
      (active fluidics system). This should also result in reduced deepening of the anterior
      chamber and less risk of the adverse events as explained above.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Anterior chamber depth
time frame: 12 months
description: Anterior chamber depth will be measured using the IOL Master 700. Fluctuations in anterior chamber depth will be compared between the eyes where Stellaris and the contralateral eyes in which the Stellaris Elite platform was used
measure: Patients discomfort
time frame: 12 months
description: Patients will be asked concerning their discomfort during both cataract surgeries and results will be recorded using an visual analogue scale. In the visual analogue scale 10 means highest discomfort and 1 stands for lowest discomfort.
arm group label: Myopic patients
arm group type: Experimental
description: In myopic patients with axial length over 25.0 mm during surgery of the first eye the Stellaris platform will be used and during surgery of the second eye the Stellaris Elite platform will be used
intervention type: Device
intervention name: Stellaris Elite
description: The Stellaris and the Stellaris Elite platform will be used in myopic patients (axial length > 25.0 mm) during cataract surgery
arm group label: Myopic patients
criteria: 
gender: All
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: No
last name: Kristina Stjepanek, MD
phone: 01 91021-57564
email: office@viros.at
last name: Julius Hienert, MD
phone: 01 91021-57564
email: office@viros.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: Undecided