xml: <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/NCT06016231</url>
    </required_header>
    <id_info>
      <org_study_id>IIT-004</org_study_id>
      <nct_id>NCT06016231</nct_id>
    </id_info>
    <brief_title>Clinical Outcomes of Patients With a Light Adjustable Lens (LAL) in at Least One Eye</brief_title>
    <official_title>Clinial Outcomes of Bilateral Pseudophakic Patients With a Light Adjustable Lens (LAL) Implanted in at Least One Eye</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bucci Laser Vision Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bucci Laser Vision 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        To collect data on bilateral pseudophakic patients implanted with the RxSight Light&#xD;
        Adjustable Lens (LAL) in at least one eye&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Satisfaction - subjective questionnaire</measure>
      <time_frame>3-18 months after cataract surgery</time_frame>
      <description>Subjective questionnaire explores the frequency/need for glasses for various visual functions at distance/intermediate/near, experience with dysphotopsias, and overall satisfaction of visual function without glasses.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>IOL</condition>
    <arm_group>
      <arm_group_label>LAL in at least one eye</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Light Adjustable Lens</intervention_name>
      <description>The Light Adjustable Lens (LAL) is a posterior chamber, UV absorbing, three-piece, foldable, photoreactive silicone intraocular lens with a squared posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure of the implanted RxSight LAL using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change post-operatively. A subsequent lock-in exposure is delivered to the implanted LAL to stabilize the lens power.</description>
      <arm_group_label>LAL in at least one eye</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Bilateral pseudophakia in adults implanted with the LAL in at least one eye and who have&#xD;
          completed Light Delivery Device (LDD) light treatments&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults with bilateral pseudophakia who have been implanted with the LAL in at least&#xD;
               one eye and who have completed LDD light treatments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Visually significant eye disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Frank A Bucci, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bucci Laser Vision Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Bucci Laser Vision Institute</name>
        <address>
          <city>Wilkes-Barre</city>
          <state>Pennsylvania</state>
          <zip>18702</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016231
  org study id: IIT-004
  nct id: NCT06016231
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  To collect data on bilateral pseudophakic patients implanted with the RxSight Light
        Adjustable Lens (LAL) in at least one eye
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Patient Satisfaction - subjective questionnaire
  time frame: 3-18 months after cataract surgery
  description: Subjective questionnaire explores the frequency/need for glasses for various visual functions at distance/intermediate/near, experience with dysphotopsias, and overall satisfaction of visual function without glasses.
  arm group label: LAL in at least one eye
  intervention type: Device
  intervention name: Light Adjustable Lens
  description: The Light Adjustable Lens (LAL) is a posterior chamber, UV absorbing, three-piece, foldable, photoreactive silicone intraocular lens with a squared posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure of the implanted RxSight LAL using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change post-operatively. A subsequent lock-in exposure is delivered to the implanted LAL to stabilize the lens power.
  arm group label: LAL in at least one eye
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frank A Bucci, MD
  role: Principal Investigator
  affiliation: Bucci Laser Vision Institute
  facility: 
  country: United States
  responsible party type: Sponsor