<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/NCT04405648</url>
  </required_header>
  <id_info>
    <org_study_id>4-8/1/2018</org_study_id>
    <nct_id>NCT04405648</nct_id>
  </id_info>
  <brief_title>Computer Vision Syndrome Prevalence Among University Students</brief_title>
  <official_title>Prevalence and Severity of Computer Vision Syndrome Among Medical Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</source>
  <oversight_info>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity&#xD;
      among medical students&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CVS-F3 is a valid questionnaire that includes 26 questions to be responded by the medical&#xD;
      students to detect CVS complains and possible complications. The questionnaire includes&#xD;
      questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric&#xD;
      complains caused by CVS. Complete statistical analysis of the survey data will be done using&#xD;
      univariate and multivariate logistic and linear regression analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of CVS</measure>
    <time_frame>1 month</time_frame>
    <description>will be reorted in form of percentage (%) of students with CVS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of visual acuity using distance visual charts in logMAR measurements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Refraction</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of refractive power in diopters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schirmer test</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of tear volume production with Schirmer test in mm unit measurements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tear Break Up Time (TBUT)</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of tear film stability with TBUT in seconds time unit measurements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mfERG examinations</measure>
    <time_frame>6 months</time_frame>
    <description>mfERG will be performed for the students to document the effect of CVS on retina</description>
  </primary_outcome>
  <enrollment type="Actual">49</enrollment>
  <condition>Computer Vision Syndrome</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CVS GROUP</intervention_name>
    <description>the students will respond to CVS-F3 questionnaire to report their potential CVS complains and associated screen factors as screen-time, screen-size, screen-resolution and other factors.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        medical students who are using screens in their medical studies or personal lives and how&#xD;
        these screens affect their medical studies and the effect of mandated medical computer use&#xD;
        if present on their screen-behaviour and associated risk factor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  university students&#xD;
&#xD;
          -  studying medicine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular surgery&#xD;
&#xD;
          -  amblyopia&#xD;
&#xD;
          -  anisometropia&#xD;
&#xD;
          -  strabismus&#xD;
&#xD;
          -  DM&#xD;
&#xD;
          -  hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed Iqbal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sohag University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>Sohag</city>
        <zip>82425</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sohag Faculty of Medicine</name>
      <address>
        <city>Sohag</city>
        <zip>82425</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>Prof. Mohammed Iqbal</investigator_full_name>
    <investigator_title>Assistant Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT04405648
org study id: 4-8/1/2018
nct id: NCT04405648
lead sponsor: 
is fda regulated device: No
CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity
      among medical students
CVS-F3 is a valid questionnaire that includes 26 questions to be responded by the medical
      students to detect CVS complains and possible complications. The questionnaire includes
      questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric
      complains caused by CVS. Complete statistical analysis of the survey data will be done using
      univariate and multivariate logistic and linear regression analysis.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Prevalence of CVS
time frame: 1 month
description: will be reorted in form of percentage (%) of students with CVS
measure: Visual acuity
time frame: 1 month
description: measurement of visual acuity using distance visual charts in logMAR measurements
measure: Refraction
time frame: 1 month
description: measurement of refractive power in diopters
measure: Schirmer test
time frame: 1 month
description: measurement of tear volume production with Schirmer test in mm unit measurements
measure: Tear Break Up Time (TBUT)
time frame: 1 month
description: measurement of tear film stability with TBUT in seconds time unit measurements
measure: mfERG examinations
time frame: 6 months
description: mfERG will be performed for the students to document the effect of CVS on retina
intervention type: Behavioral
intervention name: CVS GROUP
description: the students will respond to CVS-F3 questionnaire to report their potential CVS complains and associated screen factors as screen-time, screen-size, screen-resolution and other factors.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohammed Iqbal
role: Principal Investigator
affiliation: Sohag University Hospital
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: Prof. Mohammed Iqbal
investigator title: Assistant Professor of Ophthalmology
mesh term: Syndrome