<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/NCT04465279</url>
  </required_header>
  <id_info>
    <org_study_id>0000755</org_study_id>
    <nct_id>NCT04465279</nct_id>
  </id_info>
  <brief_title>Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification</brief_title>
  <official_title>Evaluation of Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</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>
      Multifocal IOLs that maintain distance focus and improve near vision have been developed to&#xD;
      reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks,&#xD;
      such as reading crafts, hobbies, and social activities to a greater extent than do monofocal&#xD;
      IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal&#xD;
      IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been&#xD;
      developed to create intermediate focus to overcome these difficulties. Continuous reports of&#xD;
      the visual outcomes of the FineVision trifocal IOLs are encouraging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monofocal IOLs, which provide effective distance vision, currently account for the majority&#xD;
      of IOLs implantations. Patients who have undergone cataract surgery with implantation of&#xD;
      monofocal IOL may require spectacles to perform near-distance (e.g., reading) or&#xD;
      intermediate-distance (e.g., using a computer) tasks depending on their visual&#xD;
      demandsMultifocal IOLs that maintain distance focus and improve near vision have been&#xD;
      developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of&#xD;
      near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent&#xD;
      than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated&#xD;
      with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology&#xD;
      has been developed to create intermediate focus to overcome these difficulties. Continuous&#xD;
      reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective, non-comparative, non-randomized study including 36 eyes had implantation of trifocal diffractive IOL</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Defocus curve</measure>
    <time_frame>3 months</time_frame>
    <description>examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast sensitivity</measure>
    <time_frame>3 months</time_frame>
    <description>using the CSV-1000 contrast test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Satisfaction Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Refractive Errors</condition>
  <arm_group>
    <arm_group_label>Trifocal Diffractive Intraocular Lens (FineVision)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 eyes having implantation of trifocal diffractive IOL (FineVision)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trifocal diffractive intraocular lens</intervention_name>
    <description>Trifocal IOL having foldable single-piece fully diffractive pupil dependent aspheric IOL. Which have been made of hydrophilic acrylic with an ultraviolet (UV) and blue light inhibitor. It has an optic diameter of 6.15 mm and an overall diameter of 10.75 mm; it has +3.5D additional power for near vision and +1.75 D additional power for intermediate vision, consisting of 26 diffractive steps.</description>
    <arm_group_label>Trifocal Diffractive Intraocular Lens (FineVision)</arm_group_label>
    <other_name>(FineVision IOL)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient eyes had cataract with no other pathology, patients desire for spectacle&#xD;
             independence after surgery and with realistic expectation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any ocular comorbidity that affect the end results of the surgery, history of ocular&#xD;
             trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular&#xD;
             abnormalities that may affect postoperative centration as tilt of the lens (e.g.&#xD;
             pseudo exfoliation syndrome and Marfan's syndrome).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ehab Mossallam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
    <mesh_term>Capsule Opacification</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/NCT04465279
org study id: 0000755
nct id: NCT04465279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multifocal IOLs that maintain distance focus and improve near vision have been developed to
      reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks,
      such as reading crafts, hobbies, and social activities to a greater extent than do monofocal
      IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal
      IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been
      developed to create intermediate focus to overcome these difficulties. Continuous reports of
      the visual outcomes of the FineVision trifocal IOLs are encouraging.
Monofocal IOLs, which provide effective distance vision, currently account for the majority
      of IOLs implantations. Patients who have undergone cataract surgery with implantation of
      monofocal IOL may require spectacles to perform near-distance (e.g., reading) or
      intermediate-distance (e.g., using a computer) tasks depending on their visual
      demandsMultifocal IOLs that maintain distance focus and improve near vision have been
      developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of
      near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent
      than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated
      with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology
      has been developed to create intermediate focus to overcome these difficulties. Continuous
      reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective, non-comparative, non-randomized study including 36 eyes had implantation of trifocal diffractive IOL
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Acuity
time frame: 3 months
description: Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision
measure: Defocus curve
time frame: 3 months
description: examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame
measure: Contrast sensitivity
time frame: 3 months
description: using the CSV-1000 contrast test.
measure: Visual Satisfaction Questionnaire
time frame: 3 months
description: Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).
arm group label: Trifocal Diffractive Intraocular Lens (FineVision)
arm group type: Experimental
description: 36 eyes having implantation of trifocal diffractive IOL (FineVision)
intervention type: Device
intervention name: Trifocal diffractive intraocular lens
description: Trifocal IOL having foldable single-piece fully diffractive pupil dependent aspheric IOL. Which have been made of hydrophilic acrylic with an ultraviolet (UV) and blue light inhibitor. It has an optic diameter of 6.15 mm and an overall diameter of 10.75 mm; it has +3.5D additional power for near vision and +1.75 D additional power for intermediate vision, consisting of 26 diffractive steps.
arm group label: Trifocal Diffractive Intraocular Lens (FineVision)
other name: (FineVision IOL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ehab Mossallam, PhD
role: Principal Investigator
affiliation: Alexandria Faculty of Medicine
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Cataract
mesh term: Refractive Errors
mesh term: Capsule Opacification
sharing ipd: No