xml: <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/NCT06002399</url>
    </required_header>
    <id_info>
      <org_study_id>23219_EDOF study</org_study_id>
      <nct_id>NCT06002399</nct_id>
    </id_info>
    <brief_title>Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison</brief_title>
    <acronym>COMEDI</acronym>
    <official_title>Combining a Monofocal With an EDOF IOL: Is There an Improvement in Quality of Vision After Cataract Surgery Over Bilateral Monofocal IOL Implantation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vrije Universiteit Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vrije Universiteit Brussel</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>
        The goal of this clinical trial is to compare visual quality after cataract surgery between&#xD;
        two groups: bilateral monofocal intraocular lenses (IOL) and monofocal and contralateral&#xD;
        extended depth-of-focus (EDOF) IOL implantation. The main question it aims to answer is:&#xD;
  &#xD;
        • does the combination of both monofocal and EDOF IOLs presents an advantage over bilateral&#xD;
        monofocal IOL implantation in the daily life of patients undergoing cataract surgery without&#xD;
        the disadvantages of bilateral EDOF IOL implantation?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  be randomised in either bilateral monofocal group or monofocal and EDOF group&#xD;
  &#xD;
          -  undergo visual acuity testing with and without correction at all distances&#xD;
  &#xD;
          -  be asked to complete a quality of vision questionnaire&#xD;
  &#xD;
          -  undergo non-invasive examinations to measure residual astigmatism, contrast sensitivity,&#xD;
             straylight, optical aberrations, reading spead.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</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>Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.</measure>
      <time_frame>3 months</time_frame>
      <description>Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Cataract</condition>
    <arm_group>
      <arm_group_label>Bilateral monofocal intraocular lens</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Standard treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Monofocal and contralateral extended depth-of-focus intraocular lens</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>cataract surgery</intervention_name>
      <description>cataract surgery</description>
      <arm_group_label>Bilateral monofocal intraocular lens</arm_group_label>
      <arm_group_label>Monofocal and contralateral extended depth-of-focus intraocular lens</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged between 50 and 90 years with bilateral cataract without concomitant&#xD;
               exclusion criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  prior refractive surgery&#xD;
  &#xD;
            -  patients with corneal opacities, retinopathy, opticopathy, glaucoma, uveitis and&#xD;
               amblyopia&#xD;
  &#xD;
            -  patients with corneal astigmatism greater than 3 diopters (D)&#xD;
  &#xD;
            -  patients with expected postoperative astigmatism higher than 0.75D&#xD;
  &#xD;
            -  prior ocular surgery in the last six months&#xD;
  &#xD;
            -  patients with prior unilateral cataract surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vrije Universiteit Brussel</investigator_affiliation>
      <investigator_full_name>Karolien Termote, MD FEBOpht</investigator_full_name>
      <investigator_title>MD FEBOpht</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cataract</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002399
  org study id: 23219_EDOF study
  nct id: NCT06002399
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare visual quality after cataract surgery between
        two groups: bilateral monofocal intraocular lenses (IOL) and monofocal and contralateral
        extended depth-of-focus (EDOF) IOL implantation. The main question it aims to answer is:
  
        • does the combination of both monofocal and EDOF IOLs presents an advantage over bilateral
        monofocal IOL implantation in the daily life of patients undergoing cataract surgery without
        the disadvantages of bilateral EDOF IOL implantation?
  
        Participants will:
  
          -  be randomised in either bilateral monofocal group or monofocal and EDOF group
  
          -  undergo visual acuity testing with and without correction at all distances
  
          -  be asked to complete a quality of vision questionnaire
  
          -  undergo non-invasive examinations to measure residual astigmatism, contrast sensitivity,
             straylight, optical aberrations, reading spead.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
  time frame: 3 months
  description: Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
  arm group label: Bilateral monofocal intraocular lens
  arm group type: Other
  description: Standard treatment
  arm group label: Monofocal and contralateral extended depth-of-focus intraocular lens
  arm group type: Experimental
  description: Experimental treatment
  intervention type: Device
  intervention name: cataract surgery
  description: cataract surgery
  arm group label: Bilateral monofocal intraocular lens
  arm group label: Monofocal and contralateral extended depth-of-focus intraocular lens
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Vrije Universiteit Brussel
  investigator full name: Karolien Termote, MD FEBOpht
  investigator title: MD FEBOpht
  mesh term: Cataract