<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/NCT03298841</url>
  </required_header>
  <id_info>
    <org_study_id>ZEISS-2017-003</org_study_id>
    <nct_id>NCT03298841</nct_id>
  </id_info>
  <brief_title>Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope</brief_title>
  <official_title>Zeiss Lumera Microscope With Callisto Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toyos Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toyos Clinic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Study design will be a mix of retrospective (older Zeiss microscope previously in use at our&#xD;
      surgery center) and prospective data collection with the Lumera and Callisto software.&#xD;
&#xD;
      The Lumera and Callisto software system will be used for all cataract surgeries including&#xD;
      toric analyses and lens placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Needs Assessment&#xD;
&#xD;
      Research on this topic is needed as over 3 million cataract surgeries are performed in the&#xD;
      United States each year. The number of surgeries performed is growing as baby boomers age.&#xD;
      Reimbursements continue to decline, necessitating ever improving operating and surgical&#xD;
      efficiencies in the operating room setting for physicians and small business owners to remain&#xD;
      financially viable. New governmental regulations dictate that physician payments will be&#xD;
      related to patient satisfaction and outcomes which may be better provided by newer and better&#xD;
      surgical technologies.&#xD;
&#xD;
      The Lumera operating microscope and Callisto software system provide several features that&#xD;
      may enhance operating room flow including HD video screen and co-observant microscopes that&#xD;
      can be independently adjusted to help operating room staff anticipate the needs of the&#xD;
      surgeon. Enhanced retroillumination would be expected to translate into fewer complications&#xD;
      and more confidence during surgery which could lead to less operating time, phaco energy used&#xD;
      and improved visual outcomes. The toric alignment assistance device may lead to more accurate&#xD;
      toric placement and improved visual outcomes after surgery.&#xD;
&#xD;
      Target audience would include all cataract surgeons both high and lower volume.&#xD;
&#xD;
      There is currently a dearth of published literature on this technology and its benefits in&#xD;
      routine cataract surgery. There are no registered similar trials on Clinicaltrials.gov&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 20, 2017</completion_date>
  <primary_completion_date type="Actual">September 20, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope</measure>
    <time_frame>during surgery assessed up to one hour</time_frame>
    <description>operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Adverse Events During Intra-operative and Post-operative Period</measure>
    <time_frame>6 weeks</time_frame>
    <description>events that are life or vision threatening, that require hospitalization or permanent disability of any type</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Cataract</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zeiss</intervention_name>
    <description>This study proposal will highlight the advanced technology features of the Zeiss Lumera surgical operating microscope which include but are not limited to:&#xD;
Stereo Coaxial Illumination for improved visualization High resolution video screen/co-observation tool to help OR staff anticipate next steps Integrated toric alignment tool Surgical microscope touch screen Cordless foot control for faster turnover between cases</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 patients with visually significant cataracts&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Visually significant cataract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not visually significant cataract&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Toyos, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toyos Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toyos Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <results_first_submitted>January 11, 2018</results_first_submitted>
  <results_first_submitted_qc>April 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 22, 2021</results_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Toyos Clinic</investigator_affiliation>
    <investigator_full_name>Melissa Toyos</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>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03298841/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03298841/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03298841/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zeiss Group</title>
          <description>patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software</description>
        </group>
        <group group_id="P2">
          <title>Leica Stativ S3B</title>
          <description>patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>sequential series of patients with uncomplicated cataracts undergoing phacoemulsification at one surgery site</population>
      <group_list>
        <group group_id="B1">
          <title>Zeiss Group</title>
          <description>patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software</description>
        </group>
        <group group_id="B2">
          <title>Leica Stativ S3B</title>
          <description>patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope</title>
        <description>operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center</description>
        <time_frame>during surgery assessed up to one hour</time_frame>
        <population>patients undergoing uncomplicated phacoemulsification by two surgeons at one surgery site</population>
        <group_list>
          <group group_id="O1">
            <title>Zeiss Group</title>
            <description>patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software</description>
          </group>
          <group group_id="O2">
            <title>Leica Stativ S3B</title>
            <description>patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope</title>
          <description>operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center</description>
          <population>patients undergoing uncomplicated phacoemulsification by two surgeons at one surgery site</population>
          <units>minutes per surgical procedure</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.15" spread="2.42"/>
                    <measurement group_id="O2" value="14.18" spread="8.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Serious Adverse Events During Intra-operative and Post-operative Period</title>
        <description>events that are life or vision threatening, that require hospitalization or permanent disability of any type</description>
        <time_frame>6 weeks</time_frame>
        <population>patients scheduled for routine cataract surgery with one of two experienced surgeons</population>
        <group_list>
          <group group_id="O1">
            <title>Cataract Surgery Patients</title>
            <description>Patients undergoing immediate cataract surgery at a single site with one of two operating microscopes</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Serious Adverse Events During Intra-operative and Post-operative Period</title>
          <description>events that are life or vision threatening, that require hospitalization or permanent disability of any type</description>
          <population>patients scheduled for routine cataract surgery with one of two experienced surgeons</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Zeiss Group</title>
          <description>patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software</description>
        </group>
        <group group_id="E2">
          <title>Leica Stativ S3B</title>
          <description>patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Melissa Toyos</name_or_title>
      <organization>Toyos Clinic</organization>
      <phone>6153274015</phone>
      <email>mtoyos@toyosclinic.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03298841
org study id: ZEISS-2017-003
nct id: NCT03298841
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study design will be a mix of retrospective (older Zeiss microscope previously in use at our
      surgery center) and prospective data collection with the Lumera and Callisto software.

      The Lumera and Callisto software system will be used for all cataract surgeries including
      toric analyses and lens placement.
Needs Assessment

      Research on this topic is needed as over 3 million cataract surgeries are performed in the
      United States each year. The number of surgeries performed is growing as baby boomers age.
      Reimbursements continue to decline, necessitating ever improving operating and surgical
      efficiencies in the operating room setting for physicians and small business owners to remain
      financially viable. New governmental regulations dictate that physician payments will be
      related to patient satisfaction and outcomes which may be better provided by newer and better
      surgical technologies.

      The Lumera operating microscope and Callisto software system provide several features that
      may enhance operating room flow including HD video screen and co-observant microscopes that
      can be independently adjusted to help operating room staff anticipate the needs of the
      surgeon. Enhanced retroillumination would be expected to translate into fewer complications
      and more confidence during surgery which could lead to less operating time, phaco energy used
      and improved visual outcomes. The toric alignment assistance device may lead to more accurate
      toric placement and improved visual outcomes after surgery.

      Target audience would include all cataract surgeons both high and lower volume.

      There is currently a dearth of published literature on this technology and its benefits in
      routine cataract surgery. There are no registered similar trials on Clinicaltrials.gov
observational model: Cohort
time perspective: Retrospective
measure: Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope
time frame: during surgery assessed up to one hour
description: operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center
measure: Number of Serious Adverse Events During Intra-operative and Post-operative Period
time frame: 6 weeks
description: events that are life or vision threatening, that require hospitalization or permanent disability of any type
intervention type: Device
intervention name: Zeiss
description: This study proposal will highlight the advanced technology features of the Zeiss Lumera surgical operating microscope which include but are not limited to:
Stereo Coaxial Illumination for improved visualization High resolution video screen/co-observation tool to help OR staff anticipate next steps Integrated toric alignment tool Surgical microscope touch screen Cordless foot control for faster turnover between cases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa Toyos, md
role: Principal Investigator
affiliation: Toyos Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Toyos Clinic
investigator full name: Melissa Toyos
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 