<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/NCT03024073</url>
  </required_header>
  <id_info>
    <org_study_id>300/13-1/2017</org_study_id>
    <nct_id>NCT03024073</nct_id>
  </id_info>
  <brief_title>Assessment of Near Vision Capacity in Different Light Intensities</brief_title>
  <official_title>Assessment of Near Vision Capacity in Different Light Intensities and Temperatures in Patients Who Underwent Pseudophakic Presbyopic Correction</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 presbyopic correction with bilateral bifocal intraocular lenses&#xD;
      implantation are supposed to have sufficient uncorrected vision capacity for activities of&#xD;
      daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is&#xD;
      known that light intensity and temperature has a great impact on near vision capacity.&#xD;
      Primary objective of this study is to identify the optimal task lighting conditions (in terms&#xD;
      of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa&#xD;
      patients who underwent presbyopic correction with bilateral bifocal intraocular lenses&#xD;
      implantation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">April 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Uncorrected Near Vision Acuity (UnVA)</measure>
    <time_frame>6 months</time_frame>
    <description>Near Vision Acuity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Near Vision Capacity (NVC)</measure>
    <time_frame>6 months</time_frame>
    <description>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="Actual">50</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>SG</arm_group_label>
    <description>Study group (patients who underwent pseudophakic presbyopic correction with bilateral bifocal lenses implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CG</arm_group_label>
    <description>Control group (age-matched participants without pseudophakic presbyopic correction)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BB-Phaco</intervention_name>
    <description>Phacoemulsification with bilateral bifocal lenses implantation</description>
    <arm_group_label>SG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral&#xD;
        bifocal intraocular lenses implantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presbyopia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Corneal pathology&#xD;
&#xD;
          -  Fundus pathology&#xD;
&#xD;
          -  Severe neurological/mental diseases that interfere with visual acuity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 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>Democritus University of Thrace</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Democritus University of Thrace</name>
      <address>
        <city>Alexandroupolis</city>
        <state>Evros</state>
        <zip>68100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</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/NCT03024073
org study id: 300/13-1/2017
nct id: NCT03024073
lead sponsor: 
has dmc: No
Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses
      implantation are supposed to have sufficient uncorrected vision capacity for activities of
      daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is
      known that light intensity and temperature has a great impact on near vision capacity.
      Primary objective of this study is to identify the optimal task lighting conditions (in terms
      of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa
      patients who underwent presbyopic correction with bilateral bifocal intraocular lenses
      implantation
observational model: Cohort
time perspective: Prospective
measure: Uncorrected Near Vision Acuity (UnVA)
time frame: 6 months
description: Near Vision Acuity
measure: Near Vision Capacity (NVC)
time frame: 6 months
description: 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: SG
description: Study group (patients who underwent pseudophakic presbyopic correction with bilateral bifocal lenses implantation
arm group label: CG
description: Control group (age-matched participants without pseudophakic presbyopic correction)
intervention type: Procedure
intervention name: BB-Phaco
description: Phacoemulsification with bilateral bifocal lenses implantation
arm group label: SG
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Georgios Labiris, MD, PhD
role: Principal Investigator
affiliation: Democritus University of Thrace
facility: 
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