<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/NCT03021707</url>
  </required_header>
  <id_info>
    <org_study_id>RFO268-E001</org_study_id>
    <nct_id>NCT03021707</nct_id>
  </id_info>
  <brief_title>Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction</brief_title>
  <official_title>Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Actual">October 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 27, 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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of optical treatment zone corneal haze</measure>
    <time_frame>Up to Month 6 (post-operative)</time_frame>
    <description>Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from screening in presence of disruption in the integrity of retinal layers in the macula</measure>
    <time_frame>Screening, Up to Month 6 (post-operative)</time_frame>
    <description>Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure</measure>
    <time_frame>Screening, Up to Month 6 (post-operative)</time_frame>
    <description>Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean percentage change in lens opacification from screening to each visit post procedure</measure>
    <time_frame>Screening, Up to Month 6 (post-operative)</time_frame>
    <description>A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean percentage change in foveal thickness from screening to each visit post procedure</measure>
    <time_frame>Screening, Up to Month 6 (post-operative)</time_frame>
    <description>Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Refractive Error - Myopia Severe</condition>
  <condition>Refractive Error - Myopia Simple</condition>
  <arm_group>
    <arm_group_label>UV-FS laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WaveLight® Ultraviolet Femtosecond (FS) Laser System</intervention_name>
    <description>Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction</description>
    <arm_group_label>UV-FS laser</arm_group_label>
    <other_name>Model 1026</other_name>
    <other_name>UV-FS laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser Assisted Lenticular Extraction</intervention_name>
    <description>Used for refractive error correction</description>
    <arm_group_label>UV-FS laser</arm_group_label>
    <other_name>UV-Femto</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400&#xD;
             in the study eye;&#xD;
&#xD;
          -  Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or&#xD;
             higher in the study eye;&#xD;
&#xD;
          -  Able to comprehend and provide documented informed consent;&#xD;
&#xD;
          -  Willing and able to comply with schedule for follow-up visits;&#xD;
&#xD;
          -  Minimum required endothelial cell density (ECD) in study eye as outlined in the&#xD;
             protocol;&#xD;
&#xD;
          -  Presence of natural lens in study eye;&#xD;
&#xD;
          -  A treatment simulation with spectacles or contact lenses on the study eye does not&#xD;
             negatively impact participant's daily activities;&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing;&#xD;
&#xD;
          -  Acute or chronic disease or illness that would increase the operative risk or confound&#xD;
             the outcomes of the study as clinically assessed by the Investigator;&#xD;
&#xD;
          -  Active implanted device, including but not limited to, heart pacemaker or&#xD;
             defibrillator, for which laser use may be a contraindication;&#xD;
&#xD;
          -  Current use of medications with known ocular side effects;&#xD;
&#xD;
          -  Predicted residual stromal bed thickness &lt;300 micrometers (μm) in study eye&#xD;
&#xD;
          -  Ocular conditions in the study eye;&#xD;
&#xD;
          -  Previous ocular surgery in the study eye that resulted in corneal distortions within&#xD;
             the treatment zone;&#xD;
&#xD;
          -  Residual, recurrent or active ocular disease that may impact study outcomes;&#xD;
&#xD;
          -  Previous or current diagnosis of dry eye;&#xD;
&#xD;
          -  Known allergic reaction to medications expected to be used preoperatively, during&#xD;
             laser refractive surgery, and for postoperative care;&#xD;
&#xD;
          -  Pre-existing corneal opacities in study eye;&#xD;
&#xD;
          -  Contact lens worn in study eye and not removed prior to study testing affected by wear&#xD;
             per timeframe specified in the protocol;&#xD;
&#xD;
          -  Other protocol-specified exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Manager, Surgical</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Dublin</city>
        <zip>18</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>168751</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>Singapore</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03021707
org study id: RFO268-E001
nct id: NCT03021707
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Presence of optical treatment zone corneal haze
time frame: Up to Month 6 (post-operative)
description: Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail.
measure: Mean change from screening in presence of disruption in the integrity of retinal layers in the macula
time frame: Screening, Up to Month 6 (post-operative)
description: Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity.
measure: Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure
time frame: Screening, Up to Month 6 (post-operative)
description: Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.
measure: Mean percentage change in lens opacification from screening to each visit post procedure
time frame: Screening, Up to Month 6 (post-operative)
description: A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned.
measure: Mean percentage change in foveal thickness from screening to each visit post procedure
time frame: Screening, Up to Month 6 (post-operative)
description: Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.
arm group label: UV-FS laser
arm group type: Experimental
description: WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)
intervention type: Device
intervention name: WaveLight® Ultraviolet Femtosecond (FS) Laser System
description: Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction
arm group label: UV-FS laser
other name: Model 1026
other name: UV-FS laser
intervention type: Procedure
intervention name: Laser Assisted Lenticular Extraction
description: Used for refractive error correction
arm group label: UV-FS laser
other name: UV-Femto
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Manager, Surgical
role: Study Director
affiliation: Alcon Research
facility: 
facility: 
facility: 
facility: 
country: Ireland
country: Singapore
country: United States
responsible party type: Sponsor
mesh term: Myopia
mesh term: Refractive Errors
sharing ipd: No