<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/NCT03306342</url>
  </required_header>
  <id_info>
    <org_study_id>PHY 1703</org_study_id>
    <nct_id>NCT03306342</nct_id>
  </id_info>
  <brief_title>Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL</brief_title>
  <acronym>PHY1703</acronym>
  <official_title>Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL</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>
      Prospective, controlled, single-surgeon, single-center post-market clinical follow up study&#xD;
      to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical investigation is a prospective, controlled, single-surgeon, single-center&#xD;
      post-market clinical follow up study whereby patients undergoing routine cataract surgery&#xD;
      will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL,&#xD;
      Liège, Belgium).&#xD;
&#xD;
      The study purpose is to obtain clinical data on visual acuity, contrast sensitivity,&#xD;
      questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.&#xD;
&#xD;
      The device under investigation (FineVision POD F GF) is a trifocal glistening-free&#xD;
      hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL&#xD;
      sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients&#xD;
      suffering from cataract development.&#xD;
&#xD;
      In total 25 patients will be recruited for this clinical study and receive a bilateral&#xD;
      implantation of FineVision POD F GF intraocular lens.&#xD;
&#xD;
      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 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2018</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</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 Uncorrected Distance Visual Acuity (UDVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manifested refraction</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Distance Visual Acuity (UDVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected Distance Visual Acuity (CDVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Intermediate Visual Acuity (DCIVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Intermediate Visual Acuity (UIVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Near Visual Acuity (DCNVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Near Visual Acuity (UNVA)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast Sensitivity</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aberrometry</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCO rate</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The rate of patients showing posterior capsular opacities (PCO) long term after surgery will be assessed. The criteria is, if the eye requires a secondary treatment to remove the PCO.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>questionnaire</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cataract</condition>
  <condition>Lens Opacities</condition>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>IOL implantation experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hydrophobic, trifocal intraocular lens POD F GF</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IOL implantation experimental</intervention_name>
    <description>Implantation of trifocal IOL POD F GF consisting of hydrophobic material</description>
    <arm_group_label>IOL implantation experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cataractous 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;
          -  Irregular astigmatism&#xD;
&#xD;
          -  Age of patient &lt; 45 years&#xD;
&#xD;
          -  Regular corneal astigmatism &gt;0.75 dioptres by an automatic keratometer or biometer or&#xD;
             &gt;1.0 dioptres if the steep axis of cylinder is between 90° and 120° in one or both&#xD;
             eyes&#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;
          -  AMD suspicious eyes (determined by OCT)&#xD;
&#xD;
          -  Complicated surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Béatrice Cochener, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular Lens</keyword>
  <keyword>trifocal</keyword>
  <keyword>hydrophobic</keyword>
  <keyword>hydrophilic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Presbyopia</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/NCT03306342
org study id: PHY 1703
nct id: NCT03306342
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, controlled, single-surgeon, single-center post-market clinical follow up study
      to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)
This clinical investigation is a prospective, controlled, single-surgeon, single-center
      post-market clinical follow up study whereby patients undergoing routine cataract surgery
      will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL,
      Liège, Belgium).

      The study purpose is to obtain clinical data on visual acuity, contrast sensitivity,
      questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.

      The device under investigation (FineVision POD F GF) is a trifocal glistening-free
      hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL
      sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients
      suffering from cataract development.

      In total 25 patients will be recruited for this clinical study and receive a bilateral
      implantation of FineVision POD F GF intraocular lens.

      Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2
      operative and 5 postoperative) over a period of 24 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: binocular Uncorrected Distance Visual Acuity (UDVA)
time frame: 3 months postoperative
description: Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
measure: Manifested refraction
time frame: 3 months postoperative
description: The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
measure: Uncorrected Distance Visual Acuity (UDVA)
time frame: 3 months postoperative
description: UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
measure: Corrected Distance Visual Acuity (CDVA)
time frame: 3 months postoperative
description: CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
measure: Distance Corrected Intermediate Visual Acuity (DCIVA)
time frame: 3 months postoperative
description: DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
measure: Uncorrected Intermediate Visual Acuity (UIVA)
time frame: 3 months postoperative
description: UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
measure: Distance Corrected Near Visual Acuity (DCNVA)
time frame: 3 months postoperative
description: DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
measure: Uncorrected Near Visual Acuity (UNVA)
time frame: 3 months postoperative
description: UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
measure: Contrast Sensitivity
time frame: 3 months postoperative
description: Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
measure: Aberrometry
time frame: 3 months postoperative
description: Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
measure: PCO rate
time frame: 2 years postoperative
description: The rate of patients showing posterior capsular opacities (PCO) long term after surgery will be assessed. The criteria is, if the eye requires a secondary treatment to remove the PCO.
measure: questionnaire
time frame: 3 months postoperative
description: Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100.
arm group label: IOL implantation experimental
arm group type: Experimental
description: hydrophobic, trifocal intraocular lens POD F GF
intervention type: Device
intervention name: IOL implantation experimental
description: Implantation of trifocal IOL POD F GF consisting of hydrophobic material
arm group label: IOL implantation experimental
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Béatrice Cochener, Prof.
role: Principal Investigator
affiliation: Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
facility: 
country: France
responsible party type: Sponsor
mesh term: Cataract
mesh term: Presbyopia
sharing ipd: No