<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/NCT03021512</url>
  </required_header>
  <id_info>
    <org_study_id>299/13-1-2017</org_study_id>
    <nct_id>NCT03021512</nct_id>
  </id_info>
  <brief_title>Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction</brief_title>
  <official_title>Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Democritus University of Thrace</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Democritus University of Thrace</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia&#xD;
      correction with monofocal intraocular lenses implantation are supposed to have sufficient&#xD;
      uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant&#xD;
      vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c)&#xD;
      near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a&#xD;
      series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses&#xD;
      implantation, group 2: subjects with bilateral trifocal lenses implantation)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Capacity (VC)</measure>
    <time_frame>1 year following surgery</time_frame>
    <description>Assessment of Visual capacity (VC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distant Visual Capacity (DVC)</measure>
    <time_frame>1 year following surgery</time_frame>
    <description>Visual capacity for activities that require distant vision (DVC). DVC score will be measured by the performance score in the following ADLs: a) walking specific pathway, 2) walking up stairs, 3) walking down stairs, 4) day-time driving simulation, 5) night-time driving simulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intermediate Visual Capacity (IVC)</measure>
    <time_frame>1 year following surgery</time_frame>
    <description>Visual Capacity for activities that require intermediate vision (IVC). VC score will be measured by the performance score in the following ADLs: a) reading ability of movie subtitles, b) reading ability of a predefined computer screen text, c) reading a supermarket badge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near Visual Capacity (NVC)</measure>
    <time_frame>1 year follwoing surgery</time_frame>
    <description>Visual Capacity for activities that require near vision (NVC). NVC score will be measured by the performance score in the following ADLs: a) cellular phone directory entry search, b) reading of message in a cellular phone, c) reading a medical prescription, d) reading a public phonebook</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Group 1 (BFG)</arm_group_label>
    <description>(Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (TFG)</arm_group_label>
    <description>(Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Phaco with Restor</intervention_name>
    <description>Phacoemulsification with bilateral bifocal intraocular lenses implantation</description>
    <arm_group_label>Group 1 (BFG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Phaco with Panoptix</intervention_name>
    <description>Phacoemulsification with bilateral trifocal intraocular lenses implantation</description>
    <arm_group_label>Group 2 (TFG)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Grade 1 Cataract Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular&#xD;
             lenses implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georgios Labiris, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dimitrios Aggelonias</last_name>
    <phone>00302551039891</phone>
    <email>dimagelonias@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Democritus University of Thrace</name>
      <address>
        <city>Alexandhroupolis</city>
        <state>Evros</state>
        <zip>68100</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georgios Labiris, MD, PhD</last_name>
      <phone>00302551030990</phone>
      <email>labiris@usa.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Democritus University of Thrace</investigator_affiliation>
    <investigator_full_name>Georgios Labiris</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021512
org study id: 299/13-1-2017
nct id: NCT03021512
lead sponsor: 
has dmc: No
Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia
      correction with monofocal intraocular lenses implantation are supposed to have sufficient
      uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant
      vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c)
      near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a
      series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses
      implantation, group 2: subjects with bilateral trifocal lenses implantation)
observational model: Cohort
time perspective: Retrospective
measure: Visual Capacity (VC)
time frame: 1 year following surgery
description: Assessment of Visual capacity (VC)
measure: Distant Visual Capacity (DVC)
time frame: 1 year following surgery
description: Visual capacity for activities that require distant vision (DVC). DVC score will be measured by the performance score in the following ADLs: a) walking specific pathway, 2) walking up stairs, 3) walking down stairs, 4) day-time driving simulation, 5) night-time driving simulation
measure: Intermediate Visual Capacity (IVC)
time frame: 1 year following surgery
description: Visual Capacity for activities that require intermediate vision (IVC). VC score will be measured by the performance score in the following ADLs: a) reading ability of movie subtitles, b) reading ability of a predefined computer screen text, c) reading a supermarket badge
measure: Near Visual Capacity (NVC)
time frame: 1 year follwoing surgery
description: Visual Capacity for activities that require near vision (NVC). NVC score will be measured by the performance score in the following ADLs: a) cellular phone directory entry search, b) reading of message in a cellular phone, c) reading a medical prescription, d) reading a public phonebook
arm group label: Group 1 (BFG)
description: (Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention).
arm group label: Group 2 (TFG)
description: (Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention).
intervention type: Procedure
intervention name: Phaco with Restor
description: Phacoemulsification with bilateral bifocal intraocular lenses implantation
arm group label: Group 1 (BFG)
intervention type: Procedure
intervention name: Phaco with Panoptix
description: Phacoemulsification with bilateral trifocal intraocular lenses implantation
arm group label: Group 2 (TFG)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
last name: Georgios Labiris, MD, PhD
role: Principal Investigator
affiliation: Assistant Professor
last name: Dimitrios Aggelonias
phone: 00302551039891
email: dimagelonias@yahoo.com
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Democritus University of Thrace
investigator full name: Georgios Labiris
investigator title: Assistant Professor
mesh term: Presbyopia
sharing ipd: No