<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/NCT04468308</url>
  </required_header>
  <id_info>
    <org_study_id>VRQOL Cataract COVID-19</org_study_id>
    <nct_id>NCT04468308</nct_id>
  </id_info>
  <brief_title>VRQOL in Cataract Patients During the COVID-19 Pandemic</brief_title>
  <official_title>Assessment of Vision-related Quality of Life (VRQOL) in Cataract Patients During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</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>
      The aim of this questionnaire survey is to evaluate the improvement in vision-related quality&#xD;
      of life before and after cataract surgery using the National Eye Institute Visual Function&#xD;
      Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</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>Improvement Vision-related quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Extent of improvement of vision-related qualitiy of life due to cataract surgery measured with the National Eye Institut Visual Function Questionnaire 25.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delay of Vision-related quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Delay of improvement of vision-related qualitiy of life in the COVID-19 pandemic measured in days between the originally scheduled operation and the actual operation date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>1 month</time_frame>
    <description>Visual acuity difference between visual acuity at the time of indication for cataract surgery, on the day of surgery and one month postoperatively.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Senile Cataract</condition>
  <arm_group>
    <arm_group_label>Senile Cataract</arm_group_label>
    <description>Patient with senile cataract, whose cataract surgery was postponed in the COVID-19 pandemic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively.</description>
    <arm_group_label>Senile Cataract</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with senile cataract with indication for for unilateral or bilateral cataract&#xD;
        surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 50 years&#xD;
&#xD;
          -  Senile cataract&#xD;
&#xD;
          -  Indication for unilateral or bilateral cataract surgery&#xD;
&#xD;
          -  Postponed cataract surgery due to the COVID-19 pandemic&#xD;
&#xD;
          -  Signed and dated declaration of consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complex form of cataract (traumatic cataract, secondary cataract after intraocular&#xD;
             inflammation)&#xD;
&#xD;
          -  Amblyopia on the eye that is to be operated on&#xD;
&#xD;
          -  Severe, visually impairing eye disease on the eye that is to operated on&#xD;
&#xD;
          -  Known dementia or memory problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Teresa Rauchegger, Dr.</last_name>
    <phone>+43 512 504 23721</phone>
    <email>teresa.rauchegger@i-med.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claus Zehetner, Dr.</last_name>
    <phone>+43 512 504 23721</phone>
    <email>claus.zehetner@i-med.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teresa Rauchegger, Dr.</last_name>
      <phone>+43 512 504 24184</phone>
      <email>teresa.rauchegger@i-med.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Claus Zehetner, Dr.</last_name>
      <phone>+43 512 504 24184</phone>
      <email>claus.zehetner@i-med.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 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>COVID-19</mesh_term>
    <mesh_term>Cataract</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/NCT04468308
org study id: VRQOL Cataract COVID-19
nct id: NCT04468308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this questionnaire survey is to evaluate the improvement in vision-related quality
      of life before and after cataract surgery using the National Eye Institute Visual Function
      Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.
observational model: Cohort
time perspective: Prospective
measure: Improvement Vision-related quality of life
time frame: 3 months
description: Extent of improvement of vision-related qualitiy of life due to cataract surgery measured with the National Eye Institut Visual Function Questionnaire 25.
measure: Delay of Vision-related quality of life
time frame: 3 months
description: Delay of improvement of vision-related qualitiy of life in the COVID-19 pandemic measured in days between the originally scheduled operation and the actual operation date
measure: Visual acuity
time frame: 1 month
description: Visual acuity difference between visual acuity at the time of indication for cataract surgery, on the day of surgery and one month postoperatively.
arm group label: Senile Cataract
description: Patient with senile cataract, whose cataract surgery was postponed in the COVID-19 pandemic
intervention type: Other
intervention name: Questionnaire
description: Patients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively.
arm group label: Senile Cataract
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
last name: Teresa Rauchegger, Dr.
phone: +43 512 504 23721
email: teresa.rauchegger@i-med.ac.at
last name: Claus Zehetner, Dr.
phone: +43 512 504 23721
email: claus.zehetner@i-med.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Cataract
sharing ipd: No