<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/NCT03306355</url>
  </required_header>
  <id_info>
    <org_study_id>PHY 1706</org_study_id>
    <nct_id>NCT03306355</nct_id>
  </id_info>
  <brief_title>Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes</brief_title>
  <acronym>PHY1706</acronym>
  <official_title>Clinical Study to Compare Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes</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, randomised, controlled, single-surgeon, single-center clinical study to compare&#xD;
      the clinical outcomes of two trifocal IOLs with different material (hydrophobic and&#xD;
      hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomised, controlled, single-surgeon, single-center clinical study&#xD;
      whereby patients undergoing routine cataract surgery will have bilateral implantation of&#xD;
      trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL&#xD;
      FineVision POD F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège,&#xD;
      Belgium).&#xD;
&#xD;
      The devices under investigation (FineVision POD F GF and POD F) are trifocal glistening-free&#xD;
      acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv.&#xD;
      The main difference between the lenses is the material (hydrophobic and hydrophilic). The&#xD;
      IOLs will be implanted as part of the routine cataract surgery on patients suffering from&#xD;
      cataract development.&#xD;
&#xD;
      Subjects participating in the trial will attend a total of 12 study visits (1 preoperative, 2&#xD;
      operative and 9 postoperative) over a period of 36 months. Subjects would have the option for&#xD;
      unscheduled visits if required medically.&#xD;
&#xD;
      Primary endpoint data will be collected at the 3 months follow up visit and secondary&#xD;
      endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. Data&#xD;
      analyses will be done after the last patient finished the final examination to support the&#xD;
      study publication plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">February 10, 2022</completion_date>
  <primary_completion_date type="Actual">January 24, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p &lt; 0.05) will be considered statistically significant. 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>Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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) - monocular</measure>
    <time_frame>1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Distance Visual Acuity (UDVA) - binocular</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected Distance Visual Acuity (CDVA) - monocular</measure>
    <time_frame>Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected Distance Visual Acuity (CDVA) - binocular</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular</measure>
    <time_frame>1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular</measure>
    <time_frame>1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular</measure>
    <time_frame>1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Near Visual Acuity at 35cm (UNVA)</measure>
    <time_frame>1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Near Visual Acuity at 35cm (UNVA)</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast Sensitivity</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.</time_frame>
    <description>Contrast Sensitivity under photopic and mesopic light conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aberrometry</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>AcuTarget diagnostic device</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.</time_frame>
    <description>Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Functioning Questionnaire - 25 (VFQ-25)</measure>
    <time_frame>3 months postoperative, 12 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 Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Defocus Curve</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.</time_frame>
    <description>To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed monocularly and binocularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slitlamp examination - Corneal Status</measure>
    <time_frame>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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>Keratometry</measure>
    <time_frame>Pre-OP</time_frame>
    <description>Keratometric measurements are performed to calculate the required IOL power</description>
  </other_outcome>
  <other_outcome>
    <measure>Biometry</measure>
    <time_frame>Pre-OP</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">45</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>
  <arm_group>
    <arm_group_label>IOL implantation active comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>hydrophilic, trifocal intraocular lens POD F</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 active comparator</intervention_name>
    <description>Implantation of trifocal IOL POD F consisting of hydrophilic material</description>
    <arm_group_label>IOL implantation active comparator</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;
          -  Unrealistic expectation&#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;
          -  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;
          -  Age-related Macular Degeneration (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>Robert Edward Ang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asian Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asian Eye Institute</name>
      <address>
        <city>Makati City</city>
        <zip>1200</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 28, 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>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</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/NCT03306355
org study id: PHY 1706
nct id: NCT03306355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare
      the clinical outcomes of two trifocal IOLs with different material (hydrophobic and
      hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.
This is a prospective, randomised, controlled, single-surgeon, single-center clinical study
      whereby patients undergoing routine cataract surgery will have bilateral implantation of
      trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL
      FineVision POD F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège,
      Belgium).

      The devices under investigation (FineVision POD F GF and POD F) are trifocal glistening-free
      acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv.
      The main difference between the lenses is the material (hydrophobic and hydrophilic). The
      IOLs will be implanted as part of the routine cataract surgery on patients suffering from
      cataract development.

      Subjects participating in the trial will attend a total of 12 study visits (1 preoperative, 2
      operative and 9 postoperative) over a period of 36 months. Subjects would have the option for
      unscheduled visits if required medically.

      Primary endpoint data will be collected at the 3 months follow up visit and secondary
      endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. Data
      analyses will be done after the last patient finished the final examination to support the
      study publication plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
time frame: 3 months postoperative
description: No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
measure: Manifested refraction
time frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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) - monocular
time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
description: UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly.
measure: Uncorrected Distance Visual Acuity (UDVA) - binocular
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
description: UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.
measure: Corrected Distance Visual Acuity (CDVA) - monocular
time frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.
measure: Corrected Distance Visual Acuity (CDVA) - binocular
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.
measure: Uncorrected Near Visual Acuity at 35cm (UNVA)
time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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.
measure: Uncorrected Near Visual Acuity at 35cm (UNVA)
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 binocularly.
measure: Contrast Sensitivity
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
description: Contrast Sensitivity under photopic and mesopic light conditions
measure: Aberrometry
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: AcuTarget diagnostic device
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
description: Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
measure: Visual Functioning Questionnaire - 25 (VFQ-25)
time frame: 3 months postoperative, 12 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 Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.
measure: Defocus Curve
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
description: To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed monocularly and binocularly.
measure: Slitlamp examination - Corneal Status
time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
description: The IOP will be measured with non-contact tonometer as part of the routine follow up examinations
measure: Keratometry
time frame: Pre-OP
description: Keratometric measurements are performed to calculate the required IOL power
measure: Biometry
time frame: Pre-OP
description: Biometry measurements are performed to calculate the required IOL power
arm group label: IOL implantation experimental
arm group type: Experimental
description: hydrophobic, trifocal intraocular lens POD F GF
arm group label: IOL implantation active comparator
arm group type: Active Comparator
description: hydrophilic, trifocal intraocular lens POD F
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 active comparator
description: Implantation of trifocal IOL POD F consisting of hydrophilic material
arm group label: IOL implantation active comparator
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Edward Ang, MD
role: Principal Investigator
affiliation: Asian Eye Institute
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Cataract
mesh term: Presbyopia
sharing ipd: No