<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/NCT03297372</url>
  </required_header>
  <id_info>
    <org_study_id>PHY1604</org_study_id>
    <nct_id>NCT03297372</nct_id>
  </id_info>
  <brief_title>Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.</brief_title>
  <official_title>Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.</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>
      The clinical investigation is a post-market clinical follow up study whereby patients&#xD;
      undergoing routine cataract surgery will have monolateral implantation of a commercially&#xD;
      available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp&#xD;
      examinations and posterior capsule opacification (PCO) grading.&#xD;
&#xD;
      Follow up will be up to 24 months postoperative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">September 8, 2022</completion_date>
  <primary_completion_date type="Actual">September 8, 2022</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>monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Posterior capsule opacification (PCO) grading</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>grade of the PCO determined by slitlamp</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Distance Visual acuity (UDVA)</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Monocular Uncorrected Distance Visual acuity (UDVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast Sensitivity</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Contrast Sensitivity under photopic and mesopic light conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glistening assessment</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Assessment of glistenings by slitlamp determination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Cataract</condition>
  <condition>Lens Opacities</condition>
  <arm_group>
    <arm_group_label>IOL Implantation experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of Micropure 1.2.3. in one of the eyes of the study subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IOL implantation</intervention_name>
    <description>Implantation of monofocal IOL Micropure 1.2.3</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;
          -  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 D on study eye 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>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Domenico Schiano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione GB Bietti - IRCCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico</name>
      <address>
        <city>Rome</city>
        <zip>00184</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione GB Bietti - IRCCS</name>
      <address>
        <city>Rome</city>
        <zip>00198</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular lens</keyword>
  <keyword>monofocal</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/NCT03297372
org study id: PHY1604
nct id: NCT03297372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The clinical investigation is a post-market clinical follow up study whereby patients
      undergoing routine cataract surgery will have monolateral implantation of a commercially
      available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).
The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp
      examinations and posterior capsule opacification (PCO) grading.

      Follow up will be up to 24 months postoperative.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
time frame: 6 months postoperative
description: The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).
measure: Posterior capsule opacification (PCO) grading
time frame: 2 years postoperative
description: grade of the PCO determined by slitlamp
measure: Uncorrected Distance Visual acuity (UDVA)
time frame: 6 months postoperative
description: Monocular Uncorrected Distance Visual acuity (UDVA)
measure: Contrast Sensitivity
time frame: 6 months postoperative
description: Contrast Sensitivity under photopic and mesopic light conditions
measure: Glistening assessment
time frame: 2 years postoperative
description: Assessment of glistenings by slitlamp determination
arm group label: IOL Implantation experimental
arm group type: Experimental
description: Implantation of Micropure 1.2.3. in one of the eyes of the study subject
intervention type: Device
intervention name: IOL implantation
description: Implantation of monofocal IOL Micropure 1.2.3
arm group label: IOL Implantation experimental
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Domenico Schiano, MD
role: Principal Investigator
affiliation: Fondazione GB Bietti - IRCCS
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No