<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/NCT04465344</url>
  </required_header>
  <id_info>
    <org_study_id>CE2001</org_study_id>
    <nct_id>NCT04465344</nct_id>
  </id_info>
  <brief_title>Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens</brief_title>
  <official_title>Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cutting Edge SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>targomedGmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cutting Edge SAS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be a multicentric, prospective open-label ethics committee approved clinical&#xD;
      study to investigate safety, visual outcomes, contrast sensitivity and rotational stability&#xD;
      after bilateral implantation of Isatis TF IOL following cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a staged, multicentric, controlled, prospective, open-label clinical study whereby&#xD;
      patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic&#xD;
      acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device&#xD;
      Isatis.&#xD;
&#xD;
      The investigational device, Control lens and all study products, including the devices used&#xD;
      for the study examinations, will be used within the intended use specifications from the&#xD;
      manufacturer. In addition, no invasive or other burdening examinations will occur for the&#xD;
      patient.&#xD;
&#xD;
      The study will be carried out in up to five clinical centers in Spain.&#xD;
&#xD;
      The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL)&#xD;
      manufactured by the sponsor of this study. The trifocality of this investigational device is&#xD;
      based on a purely refractive principle with the goal to provide additional near and&#xD;
      intermediate visual acuity with low photic side effects. The IOLs will be implanted in the&#xD;
      course of routine cataract surgery and will benefit to patients suffering from cataract&#xD;
      development.&#xD;
&#xD;
      The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be&#xD;
      implanted during cataract surgery. This control lens is CE approved and commercially&#xD;
      available in Spain. Isatis monofocal lens is the parent lens of the device under&#xD;
      investigation and both lenses share mechanical and material properties.&#xD;
&#xD;
      In total 180 patients will be recruited for this clinical study and undergo bilateral&#xD;
      implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects&#xD;
      participating in the trial will attend a total of maximum 11 study visits over a period of&#xD;
      11-13 months. Subjects would have the option for unscheduled visits if required medically.&#xD;
&#xD;
      Data analyses will be performed after the last patient finished the 120-180 days&#xD;
      postoperative examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 31, 2021</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Safety Endpoint: Rates of Adverse Events</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Performance Endpoint: Best Corrected Distance Visual Acuity</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions</measure>
    <time_frame>Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>Monocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions</measure>
    <time_frame>120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>Binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions</measure>
    <time_frame>Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Binocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions</measure>
    <time_frame>7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>Monocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions</measure>
    <time_frame>120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>Binocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions</measure>
    <time_frame>7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>Monocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions</measure>
    <time_frame>120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>Binocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions</measure>
    <time_frame>Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under mesopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Binocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions</measure>
    <time_frame>Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Monocular Distance Corrected Near Visual Acuity (DCNVA) under mesopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Binocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Manifest refraction</measure>
    <time_frame>Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>The manifest 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. This data will also be used to calculate the manifest refractive spherical equivalent (MRSE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Adjusted Mean Refractive Spherical Equivalent (MRSE)</measure>
    <time_frame>7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>The predictability of the postoperative manifest refraction will be evaluated using the absolute value of the adjusted MRSE calculated by the following formula:&#xD;
MRSEadjusted = MRSEpostop - MRSEtarget.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Defocus Curve</measure>
    <time_frame>120-180 days 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 -4.5 D to +2.0 D in 0.5 D steps. This examination is performed binocularly.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Contrast Sensitivity under photopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Contrast Sensitivity under mesopic light conditions</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Contrast Sensitivity under photopic light conditions and using a glare source</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Contrast Sensitivity under photopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.</description>
  </other_outcome>
  <other_outcome>
    <measure>Binocular Contrast Sensitivity under mesopic light conditions and using a glare source</measure>
    <time_frame>120-180 days postoperative</time_frame>
    <description>Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]</measure>
    <time_frame>preoperative, 120-180 days postoperative</time_frame>
    <description>To assess the subjective perception of disturbances by photic phenomena, the validated and verified Quality of Vision (QoV) questionnaire will be used.&#xD;
This questionnaire is a linear-scaled 30-item instrument and is designed with 10 symptoms rated in each of three scales (frequency, severity, and bothersome).&#xD;
The QoV Questionnaire provides a QoV score in terms of symptom frequency, severity, and bothersome [McAlinden et al, 2010].</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]</measure>
    <time_frame>preoperative, 120-180 days postoperative</time_frame>
    <description>To assess if difficulties in daily life occur due to impaired sight. This questionnaire is a 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009].</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]</measure>
    <time_frame>preoperative, 120-180 days postoperative</time_frame>
    <description>The PRSIQ is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence [Morlock et al, 2017].</description>
  </other_outcome>
  <other_outcome>
    <measure>Pupil Size under photopic light conditions</measure>
    <time_frame>preoperative, 120-180 days postoperative</time_frame>
    <description>Photopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. In addition to the measurement with a ruler, pupil diameters under photopic light conditions will be recorded from the preoperative Pentacam measurement.&#xD;
For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes).&#xD;
The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pupil Size under mesopic light conditions</measure>
    <time_frame>preoperative, 120-180 days postoperative</time_frame>
    <description>Mesopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes).&#xD;
The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fundus examination with dilated pupil</measure>
    <time_frame>preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - Corneal status</measure>
    <time_frame>Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - Iris status</measure>
    <time_frame>Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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;
• Iris Status</description>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - Signs of inflammation</measure>
    <time_frame>Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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&#xD;
Anterior chamber cells,&#xD;
Anterior chamber flare,&#xD;
Cystoid macular oedema,&#xD;
Hypopyon, and&#xD;
Endophthalmitis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - Pupillary block</measure>
    <time_frame>1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - Retinal detachment</measure>
    <time_frame>preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - Status of anterior and posterior capsule</measure>
    <time_frame>1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - IOL decentration</measure>
    <time_frame>1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - IOL tilt</measure>
    <time_frame>1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - IOL discoloration</measure>
    <time_frame>1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Slitlamp examination - IOL opacity</measure>
    <time_frame>1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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>
  </other_outcome>
  <other_outcome>
    <measure>Intraocular pressure (IOP) measurement</measure>
    <time_frame>Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>Keratometry</measure>
    <time_frame>Preoperative</time_frame>
    <description>Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>IOL power and target refraction</measure>
    <time_frame>day of surgery</time_frame>
    <description>The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fundus OCT</measure>
    <time_frame>Preoperative</time_frame>
    <description>An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>Biometry</measure>
    <time_frame>Preoperative</time_frame>
    <description>Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.</description>
  </other_outcome>
  <other_outcome>
    <measure>Corneal topography</measure>
    <time_frame>Preoperative</time_frame>
    <description>Pentacam device (Oculus, Germany) will be used to perform corneal topography. This examination is needed to exclude patients showing an irregular corneal astigmatism.</description>
  </other_outcome>
  <other_outcome>
    <measure>Corneal aberrometry</measure>
    <time_frame>Preoperative</time_frame>
    <description>Pentacam device (Oculus, Germany) will be used to perform corneal aberrometry measurement. The following values will be evaluated in this study: Spherical aberrations, high order aberrations.</description>
  </other_outcome>
  <other_outcome>
    <measure>IOL rotation</measure>
    <time_frame>day of surgery, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative</time_frame>
    <description>To determine the rotational stability of the lenses after implantation, the actual IOL orientation has to be recorded as the intended surgical position during surgery using a photograph through the surgery microscope or within one hour after surgery using a photograph through a slit lamp to document the rotational position of the IOL. Additional orientations are measured and recorded at the follow up visits by taking retroilluminated photographs in mydriasis using the slit lamp.&#xD;
To determine the rotational stability, it is important that the IOL axis marks of the IOL are visible as well as concurrent structures of the eye (in the same image) that are fixed and stable. Preferred fixed structures are limbal vessels. The pupil is dilated if necessary to visualize the IOL axis marks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Halo and glare scores</measure>
    <time_frame>Preoperative, 120-180 days postoperative, 330-420 days postoperative</time_frame>
    <description>A Halo and Glare simulator software (Eyeland Design Network GmbH, Germany) will be used to assess the subjective perception of photic phenomena. The patients will be asked to adjust the halo and glare level in a simulated image to the amount they perceive of such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes serve as a baseline measurement.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Cataract</condition>
  <condition>Lens Opacities</condition>
  <arm_group>
    <arm_group_label>IOL implantation experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental arm: Trifocal intraocular lens Isatis TF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IOL implantation active comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparator arm: Monofocal intraocular lens Isatis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of trifocal IOL, Isatis TF (device under investigation)</intervention_name>
    <description>Patients will be implanted with study IOL in both eyes</description>
    <arm_group_label>IOL implantation experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of monofocal IOL, Isatis (control device)</intervention_name>
    <description>Patients will be implanted with Control IOL in both eyes</description>
    <arm_group_label>IOL implantation active comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically documented age-related cataract in both eyes with no comorbidity;&#xD;
&#xD;
          -  Calculated IOL power is within the range of the investigational IOLs;&#xD;
&#xD;
          -  Male or female adults ages 50 years or older on the day of screening who have&#xD;
             cataracts in both eyes;&#xD;
&#xD;
          -  Regular corneal astigmatism (measured by topographer)&#xD;
&#xD;
          -  Astigmatism ≤1.0 D (measured by an automatic keratometer)&#xD;
&#xD;
          -  Clear intraocular media other than cataract;&#xD;
&#xD;
          -  Availability, willingness and sufficient cognitive awareness to comply with&#xD;
             examination procedures;&#xD;
&#xD;
          -  Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion&#xD;
             criteria applies only to the study group, not the control group);&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age of patient &lt; 50 years;&#xD;
&#xD;
          -  Regular corneal astigmatism &gt;1.0 dioptres (measured by an automatic keratometer)&#xD;
&#xD;
          -  Irregular astigmatism (measured by topographer);&#xD;
&#xD;
          -  Difficulty for cooperation (distance from their home, general health conditions);&#xD;
&#xD;
          -  Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or&#xD;
             other retinal or optic disorders);&#xD;
&#xD;
          -  Subjects with AMD suspicious eyes as determined by OCT examination;&#xD;
&#xD;
          -  Previous intraocular or corneal surgery;&#xD;
&#xD;
          -  Traumatic cataract;&#xD;
&#xD;
          -  Instability of keratometry or biometry measurements; Acceptable maximum standard&#xD;
             deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;&#xD;
&#xD;
          -  Ocular hypertension, suspicious glaucoma or glaucoma;&#xD;
&#xD;
          -  Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils&#xD;
             that do not dilate under mesopic / scotopic conditions);&#xD;
&#xD;
          -  Expected complicated surgery;&#xD;
&#xD;
          -  Ocular surface disease (clinical symptoms or keratitis);&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Second eye treatment will only be performed when Best Corrected Distance Visual Acuity&#xD;
             (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);&#xD;
&#xD;
          -  Concurrent participation in another drug or device investigation.&#xD;
&#xD;
        In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued&#xD;
        when certain conditions are present at the time of surgery, including:&#xD;
&#xD;
          -  zonular instability;&#xD;
&#xD;
          -  need for iris manipulation;&#xD;
&#xD;
          -  capsular fibrosis or other opacity; and&#xD;
&#xD;
          -  inability to fixate IOL in desired position. In such cases, the subject shall be&#xD;
             followed until the condition has stabilized.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jochen Kandulla, PhD</last_name>
    <phone>+49 176 55708170</phone>
    <email>jochen.kandulla@targomed.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Line Bettinelli</last_name>
    <phone>+33 619 53 07 01</phone>
    <email>line.bettinelli@cutting-edge.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gemini Eye Clinic Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>700 30</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Slovak</last_name>
      <phone>+420 730 873 183</phone>
      <email>martin.slovak@gemini.cz</email>
    </contact>
    <contact_backup>
      <last_name>Simona Rakusanova</last_name>
      <phone>+420 730 873 184</phone>
      <email>simona.rakusonova@gemini.cz</email>
    </contact_backup>
    <investigator>
      <last_name>Dalibor Cholevik, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gemini Eye Clinic Praha-Krc</name>
      <address>
        <city>Praha</city>
        <zip>140 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Slovak</last_name>
      <phone>+420 730 873 183</phone>
      <email>martin.slovak@gemini.cz</email>
    </contact>
    <contact_backup>
      <last_name>Simona Rakusanova</last_name>
      <phone>+420 730 873 184</phone>
      <email>simona.rakusonova@gemini.cz</email>
    </contact_backup>
    <investigator>
      <last_name>Drahomira Barakova, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gemini Eye Clinic Zlín</name>
      <address>
        <city>Zlín</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Slovak</last_name>
      <phone>+420 730 873 183</phone>
      <email>martin.slovak@gemini.cz</email>
    </contact>
    <contact_backup>
      <last_name>Simona Rakusanova</last_name>
      <phone>+420 730 873 184</phone>
      <email>simona.rakusonova@gemini.cz</email>
    </contact_backup>
    <investigator>
      <last_name>Pavel Stodulka, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Donostia</name>
      <address>
        <city>Donostia San Sebastian</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Iraia Reparaz Bonilla</last_name>
      <phone>(+34) 676 52 96 84</phone>
      <email>IRAIA.REPARAZ@biodonostia.org</email>
    </contact>
    <investigator>
      <last_name>Javier Medicute del Barrio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oftalvist Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arturo Corroto</last_name>
      <email>acorroto@oftalvist.es</email>
    </contact>
    <investigator>
      <last_name>Enrique Artiaga, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marta Ibarz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marceliano Crespo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nuria Garzón Jiménez, PhD</last_name>
      <phone>(+34) 659 057 151</phone>
      <email>mgarzonj@ucm.es</email>
    </contact>
    <contact_backup>
      <last_name>Celia Villanueva</last_name>
      <phone>(+34) 91 330 39 00</phone>
      <email>celia.villanueva.hcsc@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Javier García Bella, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta Jiménez</last_name>
      <phone>(+34) 976 76 55 58</phone>
      <email>mjimenez@iisaragon.es</email>
    </contact>
    <contact_backup>
      <last_name>Irene Altemir</last_name>
      <phone>(+34) 976 76 55 58</phone>
      <email>irealtemir@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Luis Pablo Júlvez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>José M Larrosa, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francisco J Castro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vicente Polo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio J Mateo Orobia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Puzo Bayod, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.</citation>
    <PMID>20505205</PMID>
  </reference>
  <reference>
    <citation>Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.</citation>
    <PMID>28341605</PMID>
  </reference>
  <reference>
    <citation>Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.</citation>
    <PMID>19251145</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular Lens</keyword>
  <keyword>IOL</keyword>
  <keyword>hydrophobic</keyword>
  <keyword>trifocal</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/NCT04465344
org study id: CE2001
nct id: NCT04465344
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will be a multicentric, prospective open-label ethics committee approved clinical
      study to investigate safety, visual outcomes, contrast sensitivity and rotational stability
      after bilateral implantation of Isatis TF IOL following cataract surgery.
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby
      patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic
      acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device
      Isatis.

      The investigational device, Control lens and all study products, including the devices used
      for the study examinations, will be used within the intended use specifications from the
      manufacturer. In addition, no invasive or other burdening examinations will occur for the
      patient.

      The study will be carried out in up to five clinical centers in Spain.

      The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL)
      manufactured by the sponsor of this study. The trifocality of this investigational device is
      based on a purely refractive principle with the goal to provide additional near and
      intermediate visual acuity with low photic side effects. The IOLs will be implanted in the
      course of routine cataract surgery and will benefit to patients suffering from cataract
      development.

      The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be
      implanted during cataract surgery. This control lens is CE approved and commercially
      available in Spain. Isatis monofocal lens is the parent lens of the device under
      investigation and both lenses share mechanical and material properties.

      In total 180 patients will be recruited for this clinical study and undergo bilateral
      implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects
      participating in the trial will attend a total of maximum 11 study visits over a period of
      11-13 months. Subjects would have the option for unscheduled visits if required medically.

      Data analyses will be performed after the last patient finished the 120-180 days
      postoperative examination.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Safety Endpoint: Rates of Adverse Events
time frame: 120-180 days postoperative
description: The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
measure: Primary Performance Endpoint: Best Corrected Distance Visual Acuity
time frame: 120-180 days postoperative
description: The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
measure: Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
time frame: 120-180 days postoperative
description: The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
measure: Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
time frame: 120-180 days postoperative
description: Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye.
measure: Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
time frame: 120-180 days postoperative
description: Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye.
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
time frame: Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: Monocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
time frame: 120-180 days postoperative, 330-420 days postoperative
description: Binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
time frame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
description: Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
measure: Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
time frame: 120-180 days postoperative
description: Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
measure: Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
time frame: 120-180 days postoperative
description: Binocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
measure: Monocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
time frame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: Monocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
time frame: 120-180 days postoperative, 330-420 days postoperative
description: Binocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
measure: Monocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
time frame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: Monocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
measure: Binocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
time frame: 120-180 days postoperative, 330-420 days postoperative
description: Binocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
time frame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under mesopic light conditions
time frame: 120-180 days postoperative
description: Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
measure: Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
time frame: 120-180 days postoperative
description: Binocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
measure: Monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
time frame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
measure: Monocular Distance Corrected Near Visual Acuity (DCNVA) under mesopic light conditions
time frame: 120-180 days postoperative
description: Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
measure: Binocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
time frame: 120-180 days postoperative
description: Binocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
measure: Manifest refraction
time frame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
description: The manifest 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. This data will also be used to calculate the manifest refractive spherical equivalent (MRSE)
measure: Adjusted Mean Refractive Spherical Equivalent (MRSE)
time frame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: The predictability of the postoperative manifest refraction will be evaluated using the absolute value of the adjusted MRSE calculated by the following formula:
MRSEadjusted = MRSEpostop - MRSEtarget.
measure: Binocular Defocus Curve
time frame: 120-180 days 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 -4.5 D to +2.0 D in 0.5 D steps. This examination is performed binocularly.
measure: Binocular Contrast Sensitivity under photopic light conditions
time frame: 120-180 days postoperative
description: Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
measure: Binocular Contrast Sensitivity under mesopic light conditions
time frame: 120-180 days postoperative
description: Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
measure: Binocular Contrast Sensitivity under photopic light conditions and using a glare source
time frame: 120-180 days postoperative
description: Contrast Sensitivity under photopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
measure: Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
time frame: 120-180 days postoperative
description: Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
measure: Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
time frame: preoperative, 120-180 days postoperative
description: To assess the subjective perception of disturbances by photic phenomena, the validated and verified Quality of Vision (QoV) questionnaire will be used.
This questionnaire is a linear-scaled 30-item instrument and is designed with 10 symptoms rated in each of three scales (frequency, severity, and bothersome).
The QoV Questionnaire provides a QoV score in terms of symptom frequency, severity, and bothersome [McAlinden et al, 2010].
measure: Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]
time frame: preoperative, 120-180 days postoperative
description: To assess if difficulties in daily life occur due to impaired sight. This questionnaire is a 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009].
measure: Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
time frame: preoperative, 120-180 days postoperative
description: The PRSIQ is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence [Morlock et al, 2017].
measure: Pupil Size under photopic light conditions
time frame: preoperative, 120-180 days postoperative
description: Photopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. In addition to the measurement with a ruler, pupil diameters under photopic light conditions will be recorded from the preoperative Pentacam measurement.
For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes).
The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: Pupil Size under mesopic light conditions
time frame: preoperative, 120-180 days postoperative
description: Mesopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes).
The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: Fundus examination with dilated pupil
time frame: preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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 - Corneal status
time frame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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 - Iris status
time frame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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:
• Iris Status
measure: Slitlamp examination - Signs of inflammation
time frame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
Anterior chamber cells,
Anterior chamber flare,
Cystoid macular oedema,
Hypopyon, and
Endophthalmitis.
measure: Slitlamp examination - Pupillary block
time frame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days 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, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
description: The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: Keratometry
time frame: Preoperative
description: Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: IOL power and target refraction
time frame: day of surgery
description: The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: Fundus OCT
time frame: Preoperative
description: An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: Biometry
time frame: Preoperative
description: Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
measure: Corneal topography
time frame: Preoperative
description: Pentacam device (Oculus, Germany) will be used to perform corneal topography. This examination is needed to exclude patients showing an irregular corneal astigmatism.
measure: Corneal aberrometry
time frame: Preoperative
description: Pentacam device (Oculus, Germany) will be used to perform corneal aberrometry measurement. The following values will be evaluated in this study: Spherical aberrations, high order aberrations.
measure: IOL rotation
time frame: day of surgery, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
description: To determine the rotational stability of the lenses after implantation, the actual IOL orientation has to be recorded as the intended surgical position during surgery using a photograph through the surgery microscope or within one hour after surgery using a photograph through a slit lamp to document the rotational position of the IOL. Additional orientations are measured and recorded at the follow up visits by taking retroilluminated photographs in mydriasis using the slit lamp.
To determine the rotational stability, it is important that the IOL axis marks of the IOL are visible as well as concurrent structures of the eye (in the same image) that are fixed and stable. Preferred fixed structures are limbal vessels. The pupil is dilated if necessary to visualize the IOL axis marks.
measure: Halo and glare scores
time frame: Preoperative, 120-180 days postoperative, 330-420 days postoperative
description: A Halo and Glare simulator software (Eyeland Design Network GmbH, Germany) will be used to assess the subjective perception of photic phenomena. The patients will be asked to adjust the halo and glare level in a simulated image to the amount they perceive of such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes serve as a baseline measurement.
arm group label: IOL implantation experimental
arm group type: Experimental
description: Experimental arm: Trifocal intraocular lens Isatis TF
arm group label: IOL implantation active comparator
arm group type: Active Comparator
description: Comparator arm: Monofocal intraocular lens Isatis
intervention type: Device
intervention name: Implantation of trifocal IOL, Isatis TF (device under investigation)
description: Patients will be implanted with study IOL in both eyes
arm group label: IOL implantation experimental
intervention type: Device
intervention name: Implantation of monofocal IOL, Isatis (control device)
description: Patients will be implanted with Control IOL in both eyes
arm group label: IOL implantation active comparator
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jochen Kandulla, PhD
phone: +49 176 55708170
email: jochen.kandulla@targomed.de
last name: Line Bettinelli
phone: +33 619 53 07 01
email: line.bettinelli@cutting-edge.fr
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status: Recruiting
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country: Czechia
country: Spain
citation: McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
PMID: 20505205
citation: Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
PMID: 28341605
citation: Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
PMID: 19251145
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No