<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/NCT03803852</url>
  </required_header>
  <id_info>
    <org_study_id>1978/2018</org_study_id>
    <nct_id>NCT03803852</nct_id>
  </id_info>
  <brief_title>Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C &amp; Alcon Clareon Toric &amp; Hoya Vivinex Impress &amp; Hoya Nanex</brief_title>
  <official_title>Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C &amp; Alcon Clareon Toric &amp; Hoya Vivinex Impress &amp; Hoya Nanex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</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 investigational devices are approved intraocular lenses (IOL) intended to be implanted&#xD;
      after phacoemulsification in individuals suffering from age-related cataract with the need of&#xD;
      cataract surgery. Within the study, three different IOLs will be investigated and separately&#xD;
      evaluated. Cataract surgery with IOL implantation will be performed in subjects who have&#xD;
      signed an informed consent form. Postoperative examinations will be postoperative refraction,&#xD;
      visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month&#xD;
      and 4-7 months.&#xD;
&#xD;
      In the Alcon Clareon toric group, patients receive a toric IOL according to their&#xD;
      preoperative astigmatism&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">October 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 14, 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>The study involves 4 different groups. All groups will be investigated seperately Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Hoya Nanex group: 130 eyes</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of axial intraocular lens position</measure>
    <time_frame>7 months</time_frame>
    <description>Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressfrom or Alcon Clareon toric from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decentration</measure>
    <time_frame>7 months</time_frame>
    <description>Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressfrom or Alcon Clareon toric will be measured with the Casia 2 OCT. Decentration will be described as &quot;Decentration in milimeter&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tilt</measure>
    <time_frame>7 months</time_frame>
    <description>Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric will be measured with the Casia 2 OCT. Tilt will be described as &quot;Tilt in degrees at a certain axis&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>1 month</time_frame>
    <description>The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity (BCVA)</measure>
    <time_frame>7 months</time_frame>
    <description>BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCIVA in the Alcon Clareon toric group</measure>
    <time_frame>7 months</time_frame>
    <description>Uncorrected Intermediate Visual Acuity mono or bilateral</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">510</enrollment>
  <condition>Age Related Cataracts</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>0°</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°</description>
  </arm_group>
  <arm_group>
    <arm_group_label>45°</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90°</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°</description>
  </arm_group>
  <arm_group>
    <arm_group_label>135°</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraocular Lens Implantation</intervention_name>
    <description>Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens.&#xD;
Implantation of the Alcon Clareon toric IOL on the axis according to the steep meridian of the cornea</description>
    <arm_group_label>0°</arm_group_label>
    <arm_group_label>135°</arm_group_label>
    <arm_group_label>45°</arm_group_label>
    <arm_group_label>90°</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uni- or bilateral age-related cataract necessitating phacoemulsification extraction&#xD;
             and posterior IOL implantation&#xD;
&#xD;
          -  Age: 45 to 95&#xD;
&#xD;
          -  Need for spherical IOL correction between 10.00 and 30.00 D&#xD;
&#xD;
          -  Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric&#xD;
             group)&#xD;
&#xD;
          -  Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)&#xD;
&#xD;
          -  Astigmatism of at least 1.0 Diopters (Alcon Clareon toric group)&#xD;
&#xD;
          -  Pupil dilation &gt;5.5mm (Alcon Clareon toric group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preceding ocular surgery or trauma&#xD;
&#xD;
               -  Recurrent intraocular inflammation of unknown etiology&#xD;
&#xD;
               -  Uncontrolled glaucoma&#xD;
&#xD;
               -  Uncontrolled systemic or ocular disease&#xD;
&#xD;
               -  Blind fellow eye&#xD;
&#xD;
               -  Microphthalmus&#xD;
&#xD;
               -  Corneal abnormality (Corneal scaring)&#xD;
&#xD;
               -  History of uveitis/iritis&#xD;
&#xD;
               -  Iris neovascularization&#xD;
&#xD;
               -  Proliferative diabetic retinopathy&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Lactation&#xD;
&#xD;
               -  Females of childbearing age will be asked if pregnancy is possible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rupert Menapace, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rupert Menapace, Prof.Dr.</last_name>
    <phone>0043-1-40400</phone>
    <phone_ext>- 66300</phone_ext>
    <email>rupert.menapace@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Schartmueller, Dr.</last_name>
    <phone>0043-1-40400</phone>
    <phone_ext>79450</phone_ext>
    <email>daniel.schartmueller@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna Allgemeines Krankenhaus</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rupert Menapace, Prof.</last_name>
      <phone>014040066300</phone>
      <email>rupert.menapace@meduniwien.ac.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Rupert Menapace</investigator_full_name>
    <investigator_title>Ao.Univ.Prof.Dr. Rupert Menapace</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Astigmatism</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/NCT03803852
org study id: 1978/2018
nct id: NCT03803852
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigational devices are approved intraocular lenses (IOL) intended to be implanted
      after phacoemulsification in individuals suffering from age-related cataract with the need of
      cataract surgery. Within the study, three different IOLs will be investigated and separately
      evaluated. Cataract surgery with IOL implantation will be performed in subjects who have
      signed an informed consent form. Postoperative examinations will be postoperative refraction,
      visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month
      and 4-7 months.

      In the Alcon Clareon toric group, patients receive a toric IOL according to their
      preoperative astigmatism
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study involves 4 different groups. All groups will be investigated seperately Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Hoya Nanex group: 130 eyes
primary purpose: Treatment
masking: None (Open Label)
measure: Change of axial intraocular lens position
time frame: 7 months
description: Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressfrom or Alcon Clareon toric from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
measure: Decentration
time frame: 7 months
description: Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressfrom or Alcon Clareon toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"
measure: Tilt
time frame: 7 months
description: Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
measure: Anterior chamber depth
time frame: 1 month
description: The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter
measure: Best corrected visual acuity (BCVA)
time frame: 7 months
description: BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)
measure: UCIVA in the Alcon Clareon toric group
time frame: 7 months
description: Uncorrected Intermediate Visual Acuity mono or bilateral
arm group label: 0°
arm group type: Experimental
description: Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
arm group label: 45°
arm group type: Experimental
description: Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
arm group label: 90°
arm group type: Experimental
description: Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
arm group label: 135°
arm group type: Experimental
description: Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
intervention type: Device
intervention name: Intraocular Lens Implantation
description: Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens.
Implantation of the Alcon Clareon toric IOL on the axis according to the steep meridian of the cornea
arm group label: 0°
arm group label: 135°
arm group label: 45°
arm group label: 90°
criteria: 
gender: All
minimum age: 45 Years
maximum age: 95 Years
healthy volunteers: No
last name: Rupert Menapace, Prof.Dr.
role: Principal Investigator
affiliation: Medical University Vienna
last name: Rupert Menapace, Prof.Dr.
phone: 0043-1-40400
phone ext: - 66300
email: rupert.menapace@meduniwien.ac.at
last name: Daniel Schartmueller, Dr.
phone: 0043-1-40400
phone ext: 79450
email: daniel.schartmueller@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Rupert Menapace
investigator title: Ao.Univ.Prof.Dr. Rupert Menapace
mesh term: Cataract
mesh term: Astigmatism
sharing ipd: No