<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/NCT01669031</url>
  </required_header>
  <id_info>
    <org_study_id>Oftalmo_Glaucoma_002</org_study_id>
    <nct_id>NCT01669031</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial on Visual Field Training</brief_title>
  <official_title>Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oftalmologia Hospital Sotero del Rio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oftalmologia Hospital Sotero del Rio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unreliability and visual field variability is a known problem with automated perimetry in&#xD;
      both developing and developed country settings. This study will look at the effects of a&#xD;
      computer program that allows new patients to practice the visual field exam before taking the&#xD;
      actual exam. Our hypothesis is that the intervention group will have less variability as&#xD;
      measured by mean deviation between exams and greater reliability as measured by the standard&#xD;
      unreliability indexes of false positive rate, false negative rate, and fixation losses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      3 study visits. Visit 1: Baseline visit for consent, getting baseline data and finally&#xD;
      randomizing the patient. Those randomized to intervention get their first session of&#xD;
      simulated visual field (2 per eye) on a regular computer for training purposes.&#xD;
&#xD;
      Visit 2: 1 to 2 days after baseline. The intervention group gets 1 practice test per eye.&#xD;
      Then both groups get a regular automated visual field Visit 3: 1 to 2 weeks after baseline.&#xD;
      The intervention group gets 1 practice test per eye. Then both groups get a regular automated&#xD;
      visual field.&#xD;
&#xD;
      Study Ends, patient gets seen by the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The absolute value of the difference in mean deviation of the first and second visual field exam</measure>
    <time_frame>Visual field exams obtained 1 to 2 weeks apart</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile</measure>
    <time_frame>Visual field exams obtained 1 to 2 weeks apart</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group</measure>
    <time_frame>Visual field exams obtained 1 to 2 weeks apart</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the time required to complete the first and second exam</measure>
    <time_frame>Visual field exams obtained 1 to 2 weeks apart</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups</measure>
    <time_frame>Visual field exams obtained 1 to 2 weeks apart</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No practice tests are performed in this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Practice Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the 3 study visits exposed to a training session (simulated visual field test on a computer).&#xD;
Visit 1 they get 2 simulated tests tests per eye. At visits 2 and 3 they get 1 simulated test per eye. Each simulated test takes 3-15 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Practice program</intervention_name>
    <description>Each practice session (simulated visual field test on computer) takes 3-15 minutes</description>
    <arm_group_label>Practice Program</arm_group_label>
    <other_name>Computer Simulated practice Visual Field Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or greater&#xD;
&#xD;
          -  Referred to the glaucoma clinic for examination due to suspected glaucoma or glaucoma&#xD;
             diagnosis&#xD;
&#xD;
          -  No more than 1 automated visual field test within the last 4 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who cannot remain seated for 10 minutes&#xD;
&#xD;
          -  patients with neck problems that prevent them from using the field analyzer properly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Justin B Hellman, Bachelors</last_name>
    <phone>67313177</phone>
    <email>justin@tentacle.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eugenio Maul, MD/MPH</last_name>
    <email>eugenio.maul@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Sótero del Río</name>
      <address>
        <city>Santiago</city>
        <state>Puente Alto</state>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eugenio A Maul, MD/MPH</last_name>
      <phone>+56 9 66593935</phone>
      <email>eugenio.maul@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Militza Sanchez, CTO</last_name>
      <phone>+56 9 73927416</phone>
      <email>militza_a@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Eugenio A Maul, MD MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jimena Schmidt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andres Gerhard, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oftalmologia Hospital Sotero del Rio</investigator_affiliation>
    <investigator_full_name>Eugenio A. Maul</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>automated perimetry</keyword>
  <keyword>visual fields</keyword>
  <keyword>reliability</keyword>
  <keyword>vision tests/standards</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>false positive reactions</keyword>
  <keyword>false negative reactions</keyword>
  <keyword>fixation, ocular</keyword>
  <keyword>mean deviation</keyword>
  <keyword>variability</keyword>
  <keyword>program</keyword>
  <keyword>software</keyword>
  <keyword>glaucoma/diagnosis</keyword>
  <keyword>visual field tests/methods</keyword>
  <keyword>aged</keyword>
  <keyword>humans</keyword>
  <keyword>female</keyword>
  <keyword>male</keyword>
  <keyword>prospective studies</keyword>
  <keyword>reproducibility of results</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT01669031
org study id: Oftalmo_Glaucoma_002
nct id: NCT01669031
lead sponsor: 
has dmc: Yes
Unreliability and visual field variability is a known problem with automated perimetry in
      both developing and developed country settings. This study will look at the effects of a
      computer program that allows new patients to practice the visual field exam before taking the
      actual exam. Our hypothesis is that the intervention group will have less variability as
      measured by mean deviation between exams and greater reliability as measured by the standard
      unreliability indexes of false positive rate, false negative rate, and fixation losses.
3 study visits. Visit 1: Baseline visit for consent, getting baseline data and finally
      randomizing the patient. Those randomized to intervention get their first session of
      simulated visual field (2 per eye) on a regular computer for training purposes.

      Visit 2: 1 to 2 days after baseline. The intervention group gets 1 practice test per eye.
      Then both groups get a regular automated visual field Visit 3: 1 to 2 weeks after baseline.
      The intervention group gets 1 practice test per eye. Then both groups get a regular automated
      visual field.

      Study Ends, patient gets seen by the patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: The absolute value of the difference in mean deviation of the first and second visual field exam
time frame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile
time frame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group
time frame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the time required to complete the first and second exam
time frame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups
time frame: Visual field exams obtained 1 to 2 weeks apart
arm group label: Control Group
arm group type: No Intervention
description: No practice tests are performed in this arm
arm group label: Practice Program
arm group type: Experimental
description: At the 3 study visits exposed to a training session (simulated visual field test on a computer).
Visit 1 they get 2 simulated tests tests per eye. At visits 2 and 3 they get 1 simulated test per eye. Each simulated test takes 3-15 minutes
intervention type: Other
intervention name: Practice program
description: Each practice session (simulated visual field test on computer) takes 3-15 minutes
arm group label: Practice Program
other name: Computer Simulated practice Visual Field Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Justin B Hellman, Bachelors
phone: 67313177
email: justin@tentacle.net
last name: Eugenio Maul, MD/MPH
email: eugenio.maul@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Oftalmologia Hospital Sotero del Rio
investigator full name: Eugenio A. Maul
investigator title: Investigator
mesh term: Glaucoma