<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/NCT03749161</url>
  </required_header>
  <id_info>
    <org_study_id>Oculentis</org_study_id>
    <nct_id>NCT03749161</nct_id>
  </id_info>
  <brief_title>Low-add Multifocal vs. Monofocal IOLs</brief_title>
  <official_title>Comparison Between Bilateral Low-add Multifocal Intraocular Lenses and Monofocal Intraocular Lenses: A Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare low-add multifocal IOLs with monofocal IOLs to evaluate if patients in the low-add&#xD;
      multifocal IOL group have better unaided distance visual acuity compared to the monofocal&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spectacle independence is one of the main aims in modern cataract surgery. Although bilateral&#xD;
      monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of&#xD;
      patient satisfaction in distance vision, spectacle dependence for intermediate vision,&#xD;
      reading and other near vision tasks is the usual result.&#xD;
&#xD;
      There are different techniques to reduce spectacle dependence, the most common one is the use&#xD;
      of multifocal IOLs. However, a variable number of patients complain of problems, such as&#xD;
      glare or haloes (positive dysphotopsia symptoms). Dysphotopsia symptoms may vary&#xD;
      significantly from patient to patient. The real incidence of dysphotopsia like symptoms after&#xD;
      cataract surgery and multifocal IOL is unknown and the implantation of multifocal IOLs is a&#xD;
      commonly accepted contraindication in patients who are night drivers. Another characteristic&#xD;
      of many multifocal IOLs is that it can provide patients with excellent near and distance&#xD;
      vision but lack in the intermediate range.&#xD;
&#xD;
      One option to enhance intermediate vision and to leave patients with good contrast&#xD;
      sensitivity is the use of low-add multifocal IOLs. These IOLs are adequate to expectations a&#xD;
      lot of patients have, who were used to have a good distance vision and who were wearing&#xD;
      spectacles when performing near vision tasks before surgery. Many of these patients would&#xD;
      prefer to keep their reading spectacles after surgery and ideally would like to function well&#xD;
      at distance and intermediate (60 to 80 cm - computer distance, household work…) range without&#xD;
      glasses.&#xD;
&#xD;
      One example of these low-add multifocal IOLs is the LENTIS Comfort MF15 with a near add of&#xD;
      1.50D (on IOL plane). Its single, blended transition zone works to deliver patients the same&#xD;
      kind of distance vision as a monofocal IOL with the addition of enhanced intermediate vision.&#xD;
      In particular, this design provides improved vision at a distance of 60 cm and more.&#xD;
      Additional key features of the Comfort IOL include good contrast sensitivity for twilight&#xD;
      vision, optimized depth of focus, and natural imaging quality and color sensitivity.&#xD;
      Especially this type of IOL may lead to more tolerance of postoperative refractive errors due&#xD;
      to biometry and IOL power calculation imprecision. This should result in better unaided&#xD;
      distance vision and therefore higher patient satisfaction after cataract surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spectacle independence questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Spectacle independence will be assessed using a questionnaire. In this questionnaire the patient will be asked about usage of spectacles for far, near and intermediate distance. Best result will be if the patient is independent from any spectacles in the different distances.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Best corrected distance and uncorrected intermediate visual acuity will be assessed using the ETDRS charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Titmus Fly Stereo test</measure>
    <time_frame>12 months</time_frame>
    <description>Stereo Vision assessment will be done using the Titmus Fly Stereo test. The patients will be asked to detect stereoscopic objects of different difficulty levels. The result will be better, the more correct stereoscopic objects the patient will detect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Lentis comfort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive the low-add multifocal IOL during cataract surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lentis L-313</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive the monofocal IOL Lentis L-313 during cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low-add multifocal IOL</intervention_name>
    <description>Lentis comfort, low-add multifocal, IOL</description>
    <arm_group_label>Lentis comfort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monofocal IOL</intervention_name>
    <description>Lentis L-313, monofocal IOL</description>
    <arm_group_label>Lentis L-313</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age-related cataract in both eyes&#xD;
&#xD;
          -  Scheduled for bilateral cataract surgery&#xD;
&#xD;
          -  Motivated to be less spectacle dependant in the distance to intermediate vision range&#xD;
&#xD;
          -  Patients with an expected BCDVA of 0.8 snellen score or better after surgery&#xD;
&#xD;
          -  Patients with the need of an IOL Power in the range of 10 to 30D (biometry performed&#xD;
             with the IOL master 700)&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Written informed consent prior to recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)&#xD;
&#xD;
          -  Retinopathia pigmentosa&#xD;
&#xD;
          -  Chronic uveitis&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Pupil decentration &gt; 1mm center shift&#xD;
&#xD;
          -  preceded retinal surgery&#xD;
&#xD;
          -  preceded Laser-in-situ-Keratomileusis (LASIK)&#xD;
&#xD;
          -  Any ophthalmic abnormality that could compromise visual function or the measurements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>John Falasinnu, MD</last_name>
    <phone>01 / 91021 / 57559</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nino Hirnschall, MD</last_name>
    <phone>01 / 91021 / 57562</phone>
    <email>office@viros.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS)</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Falasinnu, MD</last_name>
      <phone>01 / 91021 / 57559</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Nino Hirnschall, MD</last_name>
      <phone>01 / 91021 / 57562</phone>
      <email>office@viros.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cataract Surgery</keyword>
  <keyword>Low-add intraocular lens</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>Undecided</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/NCT03749161
org study id: Oculentis
nct id: NCT03749161
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Compare low-add multifocal IOLs with monofocal IOLs to evaluate if patients in the low-add
      multifocal IOL group have better unaided distance visual acuity compared to the monofocal
      group.
Spectacle independence is one of the main aims in modern cataract surgery. Although bilateral
      monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of
      patient satisfaction in distance vision, spectacle dependence for intermediate vision,
      reading and other near vision tasks is the usual result.

      There are different techniques to reduce spectacle dependence, the most common one is the use
      of multifocal IOLs. However, a variable number of patients complain of problems, such as
      glare or haloes (positive dysphotopsia symptoms). Dysphotopsia symptoms may vary
      significantly from patient to patient. The real incidence of dysphotopsia like symptoms after
      cataract surgery and multifocal IOL is unknown and the implantation of multifocal IOLs is a
      commonly accepted contraindication in patients who are night drivers. Another characteristic
      of many multifocal IOLs is that it can provide patients with excellent near and distance
      vision but lack in the intermediate range.

      One option to enhance intermediate vision and to leave patients with good contrast
      sensitivity is the use of low-add multifocal IOLs. These IOLs are adequate to expectations a
      lot of patients have, who were used to have a good distance vision and who were wearing
      spectacles when performing near vision tasks before surgery. Many of these patients would
      prefer to keep their reading spectacles after surgery and ideally would like to function well
      at distance and intermediate (60 to 80 cm - computer distance, household work…) range without
      glasses.

      One example of these low-add multifocal IOLs is the LENTIS Comfort MF15 with a near add of
      1.50D (on IOL plane). Its single, blended transition zone works to deliver patients the same
      kind of distance vision as a monofocal IOL with the addition of enhanced intermediate vision.
      In particular, this design provides improved vision at a distance of 60 cm and more.
      Additional key features of the Comfort IOL include good contrast sensitivity for twilight
      vision, optimized depth of focus, and natural imaging quality and color sensitivity.
      Especially this type of IOL may lead to more tolerance of postoperative refractive errors due
      to biometry and IOL power calculation imprecision. This should result in better unaided
      distance vision and therefore higher patient satisfaction after cataract surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Spectacle independence questionnaire
time frame: 12 months
description: Spectacle independence will be assessed using a questionnaire. In this questionnaire the patient will be asked about usage of spectacles for far, near and intermediate distance. Best result will be if the patient is independent from any spectacles in the different distances.
measure: Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity
time frame: 12 months
description: Best corrected distance and uncorrected intermediate visual acuity will be assessed using the ETDRS charts
measure: Titmus Fly Stereo test
time frame: 12 months
description: Stereo Vision assessment will be done using the Titmus Fly Stereo test. The patients will be asked to detect stereoscopic objects of different difficulty levels. The result will be better, the more correct stereoscopic objects the patient will detect.
arm group label: Lentis comfort
arm group type: Experimental
description: Patient will receive the low-add multifocal IOL during cataract surgery
arm group label: Lentis L-313
arm group type: Experimental
description: Patient will receive the monofocal IOL Lentis L-313 during cataract surgery
intervention type: Device
intervention name: Low-add multifocal IOL
description: Lentis comfort, low-add multifocal, IOL
arm group label: Lentis comfort
intervention type: Device
intervention name: Monofocal IOL
description: Lentis L-313, monofocal IOL
arm group label: Lentis L-313
criteria: 
gender: All
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: No
last name: John Falasinnu, MD
phone: 01 / 91021 / 57559
email: office@viros.at
last name: Nino Hirnschall, MD
phone: 01 / 91021 / 57562
email: office@viros.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: Undecided