<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/NCT03796624</url>
  </required_header>
  <id_info>
    <org_study_id>PHY1803</org_study_id>
    <nct_id>NCT03796624</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses</brief_title>
  <acronym>PHY1803</acronym>
  <official_title>Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient</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, non-randomised, open, controlled, single-center post-market clinical follow&#xD;
      study about Micropure 1.2.3. and PODEYE intraocular lenses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical investigation is a prospective, non-randomised, open, controlled, single-center&#xD;
      post-market clinical follow whereby study patients undergoing routine cataract surgery will&#xD;
      have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in&#xD;
      one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in&#xD;
      the contralateral eye of the same patient.&#xD;
&#xD;
      The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on&#xD;
      patients implanted with Micropure 1.2.3. and PODEYE&#xD;
&#xD;
      The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free&#xD;
      hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study&#xD;
      PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference&#xD;
      is the mechanical design of the haptics, that is not expected to have an influence on the&#xD;
      clinical outcomes.&#xD;
&#xD;
      The IOLs will be implanted as part of the routine cataract surgery on patients suffering from&#xD;
      cataract development.&#xD;
&#xD;
      In total 76 patients will be recruited for this clinical study and receive the implantation&#xD;
      of Micropure 1.2.3. and POPDEYE intraocular lenses.&#xD;
&#xD;
      Subjects participating in the trial will attend study visits over a period of 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">June 17, 2021</completion_date>
  <primary_completion_date type="Actual">June 17, 2021</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>monocular Corrected Distance Visual Acuity (CDVA)</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manifested refraction</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 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 11979-7:2018.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under photopic light conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions</measure>
    <time_frame>preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under photopic light conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions</measure>
    <time_frame>preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Contrast Sensitivity under photopic light conditions</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Contrast Sensitivity under mesopic light conditions</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Corneal status</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• Corneal status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Fundus</measure>
    <time_frame>preoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• Fundus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Signs of inflammation</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• Signs of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Pupillary block</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• Pupillary block.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Retinal detachment</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• Retinal detachment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Status of anterior and posterior capsule</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• Status of anterior and posterior capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - IOL decentration</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• IOL decentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination IOL tilt</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• IOL tilt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - IOL discoloration</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• IOL discoloration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - IOL opacity</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.&#xD;
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:&#xD;
• IOL opacity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intraocular pressure (IOP) measurement</measure>
    <time_frame>preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative</time_frame>
    <description>The IOP will be measured with non-contact tonometer as part of the routine follow up examinations</description>
  </other_outcome>
  <other_outcome>
    <measure>Questionnaire on IOL implantation</measure>
    <time_frame>peroperative</time_frame>
    <description>A questionnaire will be handed out to the surgeon right after the surgery to document the ease of use and possible issues during IOL implantation. These data will be used to compare the outcomes to different surgery techniques or injectors. The questionnaire is not validated and the outcomes serve only for the sponsor to receive feedback if one or the other IOL is easier to implant.</description>
  </other_outcome>
  <other_outcome>
    <measure>Keratometry</measure>
    <time_frame>preoperative</time_frame>
    <description>Keratometric measurements are performed to calculate the required IOL power</description>
  </other_outcome>
  <other_outcome>
    <measure>Biometry</measure>
    <time_frame>preoperative</time_frame>
    <description>Biometry measurements are performed to calculate the required IOL power</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Cataract</condition>
  <condition>Lens Opacities</condition>
  <arm_group>
    <arm_group_label>Investigational Device Micropure 1.2.3.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of monofocal intraocular lens (IOL) &quot;Micropure 1.2.3.&quot; in one of the eyes of the study subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator PODEYE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of monofocal intraocular lens (IOL) &quot;PODEYE&quot; in the contralateral eye of the study subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Micropure 1.2.3.</intervention_name>
    <description>Implantation of intraocular lens (IOL). Name: &quot;MicroPure 1.2.3.&quot; It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted</description>
    <arm_group_label>Investigational Device Micropure 1.2.3.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PODEYE</intervention_name>
    <description>Implantation of intraocular lens (IOL). Name: &quot;PODEYE&quot; It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.</description>
    <arm_group_label>Comparator PODEYE</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;
          -  Clear intraocular media other than cataract;&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age of patient &lt; 45 years;&#xD;
&#xD;
          -  Irregular astigmatism;&#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°;&#xD;
&#xD;
          -  Difficulty for cooperation (distance from their home, general health condition);&#xD;
&#xD;
          -  Previous intraocular or corneal surgery;&#xD;
&#xD;
          -  Traumatic cataract;&#xD;
&#xD;
          -  Any ocular comorbidity;&#xD;
&#xD;
          -  Instability of keratometry or biometry measurements.&#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>Pavel Stodůlka, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gemini Eye Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GEMINI Eye Clinic</name>
      <address>
        <city>Zlin</city>
        <zip>76001</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular lens</keyword>
  <keyword>Monofocal</keyword>
  <keyword>Hydrophobic</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/NCT03796624
org study id: PHY1803
nct id: NCT03796624
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, non-randomised, open, controlled, single-center post-market clinical follow
      study about Micropure 1.2.3. and PODEYE intraocular lenses.
This clinical investigation is a prospective, non-randomised, open, controlled, single-center
      post-market clinical follow whereby study patients undergoing routine cataract surgery will
      have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in
      one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in
      the contralateral eye of the same patient.

      The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on
      patients implanted with Micropure 1.2.3. and PODEYE

      The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free
      hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study
      PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference
      is the mechanical design of the haptics, that is not expected to have an influence on the
      clinical outcomes.

      The IOLs will be implanted as part of the routine cataract surgery on patients suffering from
      cataract development.

      In total 76 patients will be recruited for this clinical study and receive the implantation
      of Micropure 1.2.3. and POPDEYE intraocular lenses.

      Subjects participating in the trial will attend study visits over a period of 12 months.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: monocular Corrected Distance Visual Acuity (CDVA)
time frame: 6 months postoperative
description: Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit.
measure: Manifested refraction
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 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 11979-7:2018.
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under photopic light conditions
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
time frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under photopic light conditions
measure: Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
time frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions
measure: Monocular Contrast Sensitivity under photopic light conditions
time frame: 6 months postoperative
description: Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
measure: Monocular Contrast Sensitivity under mesopic light conditions
time frame: 6 months postoperative
description: Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
measure: Slitlamp examination - Corneal status
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• Corneal status.
measure: Slitlamp examination - Fundus
time frame: preoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• Fundus.
measure: Slitlamp examination - Signs of inflammation
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• Signs of inflammation.
measure: Slitlamp examination - Pupillary block
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• Pupillary block.
measure: Slitlamp examination - Retinal detachment
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• Retinal detachment.
measure: Slitlamp examination - Status of anterior and posterior capsule
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• Status of anterior and posterior capsule.
measure: Slitlamp examination - IOL decentration
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• IOL decentration.
measure: Slitlamp examination IOL tilt
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• IOL tilt.
measure: Slitlamp examination - IOL discoloration
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• IOL discoloration.
measure: Slitlamp examination - IOL opacity
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
• IOL opacity.
measure: Intraocular pressure (IOP) measurement
time frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
description: The IOP will be measured with non-contact tonometer as part of the routine follow up examinations
measure: Questionnaire on IOL implantation
time frame: peroperative
description: A questionnaire will be handed out to the surgeon right after the surgery to document the ease of use and possible issues during IOL implantation. These data will be used to compare the outcomes to different surgery techniques or injectors. The questionnaire is not validated and the outcomes serve only for the sponsor to receive feedback if one or the other IOL is easier to implant.
measure: Keratometry
time frame: preoperative
description: Keratometric measurements are performed to calculate the required IOL power
measure: Biometry
time frame: preoperative
description: Biometry measurements are performed to calculate the required IOL power
arm group label: Investigational Device Micropure 1.2.3.
arm group type: Experimental
description: Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject
arm group label: Comparator PODEYE
arm group type: Active Comparator
description: Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject
intervention type: Device
intervention name: Micropure 1.2.3.
description: Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted
arm group label: Investigational Device Micropure 1.2.3.
intervention type: Device
intervention name: PODEYE
description: Implantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.
arm group label: Comparator PODEYE
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pavel Stodůlka, MD, PhD
role: Principal Investigator
affiliation: Gemini Eye Clinic
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No