<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/NCT02981186</url>
  </required_header>
  <id_info>
    <org_study_id>PHY1603</org_study_id>
    <nct_id>NCT02981186</nct_id>
  </id_info>
  <brief_title>Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)</brief_title>
  <official_title>Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)</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 study is a prospective randomised controlled study. The patients get monolateral IOL&#xD;
      implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs&#xD;
      consisting of the same optical design. The difference between the IOLs is the material&#xD;
      (hydrophilic and hydrophobic).&#xD;
&#xD;
      To decide which eye receives POD F and which eye receives POD F GF, a randomization table&#xD;
      will be provided to the principle investigator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp&#xD;
      examinations.&#xD;
&#xD;
      Follow up will be up to 6 months postoperative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2016</start_date>
  <completion_date type="Actual">September 25, 2017</completion_date>
  <primary_completion_date type="Actual">September 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity at far, near and intermediate distance</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>ability to read letters at different distances</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cataract</condition>
  <condition>Lens Opacity</condition>
  <arm_group>
    <arm_group_label>IOL Implantation experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of POD F GF in one of the eyes of the study subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IOL Implantation Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of POD F in the contralateral eye of the study subject</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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IOL implantation comparator</intervention_name>
    <description>Implantation of trifocal IOL POD F consisting of hydrophilic material</description>
    <arm_group_label>IOL Implantation Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cataractous Eyes with no comorbidity&#xD;
&#xD;
          -  Patient older than 50 years old&#xD;
&#xD;
          -  Regular corneal astigmatism &lt;0.75 dioptres by an automatic keratometer (regularity&#xD;
             determined by the topography of the keratometry) or &lt;1.0 dioptres if the steep axis of&#xD;
             cylinder is between 90° and 120°&#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;
          -  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;
      </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>Zoltan Nagy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University - Department of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Semmelweis University - Department of Ophthalmology</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</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/NCT02981186
org study id: PHY1603
nct id: NCT02981186
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective randomised controlled study. The patients get monolateral IOL
      implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs
      consisting of the same optical design. The difference between the IOLs is the material
      (hydrophilic and hydrophobic).

      To decide which eye receives POD F and which eye receives POD F GF, a randomization table
      will be provided to the principle investigator.
The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp
      examinations.

      Follow up will be up to 6 months postoperative.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Acuity at far, near and intermediate distance
time frame: 6 months postoperative
description: ability to read letters at different distances
arm group label: IOL Implantation experimental
arm group type: Experimental
description: Implantation of POD F GF in one of the eyes of the study subject
arm group label: IOL Implantation Comparator
arm group type: Active Comparator
description: Implantation of POD F in the contralateral eye of the study subject
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
intervention type: Device
intervention name: IOL implantation comparator
description: Implantation of trifocal IOL POD F consisting of hydrophilic material
arm group label: IOL Implantation Comparator
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zoltan Nagy, MD
role: Principal Investigator
affiliation: Semmelweis University - Department of Ophthalmology
facility: 
country: Hungary
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No