<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/NCT03027024</url>
  </required_header>
  <id_info>
    <org_study_id>PHY 1602</org_study_id>
    <nct_id>NCT03027024</nct_id>
  </id_info>
  <brief_title>Clinical Study to Investigate Visual Performance of IOL: FineVision HP</brief_title>
  <official_title>Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beaver-Visitec International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beaver-Visitec International, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market&#xD;
      clinical follow up study whereby patient undergoing routine cataract surgery will have&#xD;
      bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia)&#xD;
      approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and&#xD;
      secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any&#xD;
      adverse events will be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2&#xD;
      operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard&#xD;
      follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have&#xD;
      the option for unscheduled visits if required medically.&#xD;
&#xD;
      Primary endpoint data will be collected at the final visit. Data analyses will be done in the&#xD;
      end to support the study publication plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">October 22, 2018</completion_date>
  <primary_completion_date type="Actual">October 22, 2018</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>binocular Distance Corrected Near Visual Acuity (DCNVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>monocular and binocular Uncorrected Distance Visual Acuity (UDVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>monocular and binocular Corrected Distance Visual Acuity (CDVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>monocular and binocular Uncorrected Near Visual Acuity (UNVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logMAR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast Sensitivity (mesopic and photopic)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>measured in logCS</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Cataract</condition>
  <condition>Lens Opacity</condition>
  <arm_group>
    <arm_group_label>IOL Implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of IOL: PhysIOL POD F GF</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of IOL: PhysIOL POD F GF</intervention_name>
    <description>Implantation of trifocal IOL POD F GF consisting of hydrophobic material</description>
    <arm_group_label>IOL Implantation</arm_group_label>
    <other_name>PhysIOL HP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cataracteous eyes with no comorbidity&#xD;
&#xD;
          -  Spontaneously emitting the desire for spectacle independence after surgery and with&#xD;
             realistic expectation.&#xD;
&#xD;
          -  Availability, willingness and sufficient cognitive awareness to comply with&#xD;
             examination procedures&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unrealistic expectation&#xD;
&#xD;
          -  Irregular astigmatism&#xD;
&#xD;
          -  Regular corneal astigmatism &gt;0.75 D on one or both eyes as measured by an automatic&#xD;
             keratometer (regularity determined by the topography of the keratometry)&#xD;
&#xD;
          -  Difficulty for cooperation (distance from their home, general health condition)&#xD;
&#xD;
          -  Acute or chronic disease or illness that would increase risk or confound study results&#xD;
             (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)&#xD;
&#xD;
          -  Any ocular comorbidity&#xD;
&#xD;
          -  History of ocular trauma or prior ocular surgery including refractive procedures&#xD;
&#xD;
          -  Capsule or zonular abnormalities that may affect postoperative centration or tilt of&#xD;
             the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)&#xD;
&#xD;
          -  Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils&#xD;
             that do not dilate under mesopic/scotopic conditions)&#xD;
&#xD;
          -  Complicated surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uday Bhatt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vision Eye Institute - Footscray</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vision Eye Institute</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular Lens</keyword>
  <keyword>trifocal</keyword>
  <keyword>cataract</keyword>
  <keyword>PhysIOL</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>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/NCT03027024
org study id: PHY 1602
nct id: NCT03027024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market
      clinical follow up study whereby patient undergoing routine cataract surgery will have
      bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia)
      approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and
      secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any
      adverse events will be collected.
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2
      operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard
      follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have
      the option for unscheduled visits if required medically.

      Primary endpoint data will be collected at the final visit. Data analyses will be done in the
      end to support the study publication plan.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: binocular Distance Corrected Near Visual Acuity (DCNVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: monocular and binocular Corrected Distance Visual Acuity (CDVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: monocular and binocular Uncorrected Near Visual Acuity (UNVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
time frame: 3 months postoperative
description: measured in logMAR
measure: Contrast Sensitivity (mesopic and photopic)
time frame: 3 months postoperative
description: measured in logCS
arm group label: IOL Implantation
arm group type: Experimental
description: Implantation of IOL: PhysIOL POD F GF
intervention type: Device
intervention name: Implantation of IOL: PhysIOL POD F GF
description: Implantation of trifocal IOL POD F GF consisting of hydrophobic material
arm group label: IOL Implantation
other name: PhysIOL HP
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Uday Bhatt, MD
role: Principal Investigator
affiliation: Vision Eye Institute - Footscray
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No