<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/NCT03771352</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-025-03</org_study_id>
    <nct_id>NCT03771352</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism</brief_title>
  <official_title>A Prospective Multi-Center Clinical Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RxLAL) With the Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RxSight, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RxSight, Inc.</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>
      For patients undergoing cataract surgery, the purpose of this study is to evaluate a&#xD;
      patient's far vision without glasses and quality of vision after implantation and UV&#xD;
      treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light&#xD;
      treatments, the patient's far vision without glasses and quality of vision will be assessed 6&#xD;
      months postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2018</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better</measure>
    <time_frame>at 6 months postop</time_frame>
    <description>Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better</description>
  </primary_outcome>
  <other_outcome>
    <measure>Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Number of study eyes experiencing Ocular adverse events (device related and unrelated)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Eyes That Received Secondary Surgical Interventions (SSIs)</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>RxSight RxLAL IOL</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RxSight RxLAL</intervention_name>
    <description>The patients will be assessed for 6 months</description>
    <arm_group_label>RxSight RxLAL IOL</arm_group_label>
    <other_name>Light Adjustable Lens</other_name>
    <other_name>Light Delivery Device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must sign a written Informed Consent form and be willing to undergo cataract surgery&#xD;
             for the bilateral implantation of the RxLAL.&#xD;
&#xD;
          -  Greater than the age of 40 on the day the cataract surgery is performed.&#xD;
&#xD;
          -  Preoperative keratometric cylinder of &gt;=0.50 D and &lt;=4.00 D in both eyes.&#xD;
&#xD;
          -  Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level&#xD;
             of 20/32 or worse with or without glare source in both eyes.&#xD;
&#xD;
          -  Willing and able to comply with the requirements for study specific procedures and&#xD;
             visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Zonular laxity or dehiscence.&#xD;
&#xD;
          -  Age-related macular degeneration involving the presence of geographic atrophy or soft&#xD;
             drusen.&#xD;
&#xD;
          -  Retinal degenerative disorder or macular disorder (other than mild macular&#xD;
             degeneration) that is expected to cause future vision loss.&#xD;
&#xD;
          -  History of uveitis&#xD;
&#xD;
          -  Keratoconus or suspected of having keratoconus.&#xD;
&#xD;
          -  Previous corneal or intraocular surgery, except eyes with previous pterygium excision&#xD;
             are permitted as long as the pterygium did not extend more than 2mm onto the cornea&#xD;
             from the limbus.&#xD;
&#xD;
          -  Serious co-morbid conditions that in the judgement of the investigator makes inclusion&#xD;
             in the study not in the best interest of the subject.&#xD;
&#xD;
          -  Subjects taking systemic medications that may increase sensitivity to UV light.&#xD;
&#xD;
          -  Subjects taking a systemic medication that is considered toxic to the retina such as&#xD;
             tamoxifen.&#xD;
&#xD;
          -  History of ocular herpes simplex virus&#xD;
&#xD;
          -  History of congenital color vision defect&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Burkhard Dick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Eye Clinic- Bochum, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fritz Hengerer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Eye Clinic- Heidelberg, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sathish Srinivasan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ayrshire Eye Clinic and Laser Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Eye Clinic</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Eye Clinic</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ayrshire Eye Clinic and Laser Center</name>
      <address>
        <city>Ayr</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <results_first_submitted>March 19, 2021</results_first_submitted>
  <results_first_submitted_qc>April 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2021</results_first_posted>
  <last_update_submitted>May 24, 2021</last_update_submitted>
  <last_update_submitted_qc>May 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cataract surgery</keyword>
  <keyword>eye disease</keyword>
  <keyword>lenticular opacification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Astigmatism</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: CSP-025-05 rev DE protocol and SAP 05-16-2019_Redacted</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03771352/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: CSP-025 rev 5 UK protocol and SAP 05-16-2019_Redacted</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03771352/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>RxSight RxLAL IOL</title>
          <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)&#xD;
RxSight RxLAL: The patients will be assessed for 6 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51">The fellow eye of one subject was not implanted per the discretion of the investigator.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen failure</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RxSight RxLAL IOL</title>
          <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)&#xD;
RxSight RxLAL: The patients will be assessed for 6 months</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.4" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Eyes Enrolled</title>
          <description>Subjects dominant eyes were assigned to the Primary Eye Enrolled group.</description>
          <population>&quot;Primary eyes enrolled&quot; represent a count of units distributed across mutually exclusive and exhaustive categories</population>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>OD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fellow Eyes Enrolled</title>
          <description>Subjects non- dominant eyes were assigned to the Fellow Eye Enrolled group.</description>
          <population>&quot;Fellow eyes enrolled&quot; represent a count of units distributed across mutually exclusive and exhaustive categories</population>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>OD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better</title>
        <description>Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better</description>
        <time_frame>at 6 months postop</time_frame>
        <population>A modified Effectiveness (m-Effectiveness) population was used for all effectiveness analyses which includes all observed data without treatment related protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>RxSight RxLAL IOL</title>
            <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)&#xD;
RxSight RxLAL: The patients will be assessed for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better</title>
          <description>Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better</description>
          <population>A modified Effectiveness (m-Effectiveness) population was used for all effectiveness analyses which includes all observed data without treatment related protocol deviations.</population>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)</title>
        <description>Number of study eyes experiencing Ocular adverse events (device related and unrelated)</description>
        <time_frame>Through study completion, an average of 6 months</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>RxSight RxLAL IOL</title>
            <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)&#xD;
RxSight RxLAL: The patients will be assessed for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)</title>
          <description>Number of study eyes experiencing Ocular adverse events (device related and unrelated)</description>
          <population>Safety population</population>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Eyes That Received Secondary Surgical Interventions (SSIs)</title>
        <description>Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.</description>
        <time_frame>Through study completion, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RxSight RxLAL IOL</title>
            <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)&#xD;
RxSight RxLAL: The patients will be assessed for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Eyes That Received Secondary Surgical Interventions (SSIs)</title>
          <description>Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.</description>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <desc>Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.</desc>
      <group_list>
        <group group_id="E1">
          <title>RxSight RxLAL IOL</title>
          <description>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)&#xD;
RxSight RxLAL: The patients will be assessed for 6 months</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis with diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>IOL Explant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of BSCVA of ≥ 10 letters due to dry Eye</sub_title>
                <description>Compared to postop week 3</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Clinically significant cystoid macular edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Corneal Edema</sub_title>
                <description>Corneal Edema (corneal swelling (stromal or epithelial) resulting in BCDVA ≤ 20/40 after Postop Week 3</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Blurred vision right eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cornea Epithelialized with SPK</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diabetic macular edema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Increased protein distribution after lock-in procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Giant cells on anterior surface of IOL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Non-clinically significant cystoid macular edema</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Posterior Capsular Opacity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Loss of BCDVA due to Posterior Capsular Opacity</sub_title>
                <description>Compared to postop week 3</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Loss of BCDVA due to lens aberrations</sub_title>
                <description>Compared to postop week 3</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </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 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>Jeffrey Ha, Senior Director of Clinical Research</name_or_title>
      <organization>RxSight</organization>
      <phone>949-521-7870</phone>
      <email>jha@rxsight.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/NCT03771352
org study id: CSP-025-03
nct id: NCT03771352
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
For patients undergoing cataract surgery, the purpose of this study is to evaluate a
      patient's far vision without glasses and quality of vision after implantation and UV
      treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light
      treatments, the patient's far vision without glasses and quality of vision will be assessed 6
      months postoperatively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
time frame: at 6 months postop
description: Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
measure: Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)
time frame: Through study completion, an average of 6 months
description: Number of study eyes experiencing Ocular adverse events (device related and unrelated)
measure: Number of Eyes That Received Secondary Surgical Interventions (SSIs)
time frame: Through study completion, an average of 6 months
description: Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.
arm group label: RxSight RxLAL IOL
arm group type: Other
description: Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)
intervention type: Device
intervention name: RxSight RxLAL
description: The patients will be assessed for 6 months
arm group label: RxSight RxLAL IOL
other name: Light Adjustable Lens
other name: Light Delivery Device
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Burkhard Dick, MD
role: Principal Investigator
affiliation: University Eye Clinic- Bochum, Germany
last name: Fritz Hengerer, MD
role: Principal Investigator
affiliation: University Eye Clinic- Heidelberg, Germany
last name: Sathish Srinivasan, MD
role: Principal Investigator
affiliation: Ayrshire Eye Clinic and Laser Center
facility: 
facility: 
facility: 
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Cataract
mesh term: Astigmatism
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 