<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/NCT02258113</url>
  </required_header>
  <id_info>
    <org_study_id>T109/2014</org_study_id>
    <nct_id>NCT02258113</nct_id>
  </id_info>
  <brief_title>Measuring of Neuro-visual Functionality With Ocusweep</brief_title>
  <official_title>Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ocuspecto Oy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ocuspecto Oy</source>
  <brief_summary>
    <textblock>
      The aim of this study is to measure visual acuity, contrast sensitivity and visual field by&#xD;
      SAP-method using a novel device Ocusweep compared to currently widely used methods. Addition&#xD;
      to that, the aim is to validate a novel perimetry method (Visual Search Test, VST) which is&#xD;
      based on reaction times in visual decision- making task, where the subject is allowed to move&#xD;
      eyes and where the fixation is verified by the subject himself in contrast to standard&#xD;
      automatic perimetry (SAP) where prolonged stationary fixation and external fixation&#xD;
      monitoring apparatus is required. Reaction-time based visual field device Ocusweep is&#xD;
      compared to generally used SAP methods. Those tests will be done for healthy volunteers and&#xD;
      for persons with diagnosed eye or brain disease.&#xD;
&#xD;
      Ocusweep OcuRT vision based choice reaction time test is validated for test repeatability and&#xD;
      compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS)&#xD;
      reaction time tests. To evaluate the ability to detect unreliable results, OcuRT test is also&#xD;
      done under cognitive load and with instructions to cheat the test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>One visit per one patient (1h/visit)</time_frame>
    <description>Visual acuity is measured as logMAR unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast sensitivity</measure>
    <time_frame>One visit per one patient (1h/visit)</time_frame>
    <description>Contrast sensitivity is measured as logCS unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reaction time visual field</measure>
    <time_frame>One visit per one patient (1h/visit)</time_frame>
    <description>Reaction time is measured using a novel reaction-time based visual field device and compared with generally used visual field program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vision based choice reaction time</measure>
    <time_frame>One visit per one test subject (1h/visit)</time_frame>
    <description>Reaction time is measured with Ocusweep OcuRT test three times to asses repeatability of the test. OcuRT reaction time results will be compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT will also be done under cognitive load and with instructions to cheat the test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Visual Impairment</condition>
  <arm_group>
    <arm_group_label>LEA numbers, Pelli-Robson, Octopus</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ocusweep</intervention_name>
    <description>A novel reaction-time based visual field device.</description>
    <arm_group_label>LEA numbers, Pelli-Robson, Octopus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ocusweep OcuRT</intervention_name>
    <description>Vision based choice reaction time test method</description>
    <arm_group_label>LEA numbers, Pelli-Robson, Octopus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Persons suffering diagnosed eye disease&#xD;
&#xD;
          -  Persons suffering diagnosed brain disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No diabetes&#xD;
&#xD;
          -  Only one diagnosed disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Markku Leinonen, Dr</last_name>
    <email>markku.leinonen@ocuspecto.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jaakko Suominen, MSc</last_name>
    <email>jaakko.suominen@ocuspecto.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ocuspecto Oy</name>
      <address>
        <city>Turku</city>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markku Leinonen, PhD</last_name>
      <email>markku.leinonen@ocuspecto.com</email>
    </contact>
    <contact_backup>
      <last_name>Jaakko Suominen, MSc</last_name>
      <email>jaakko.suominen@ocuspecto.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 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>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</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/NCT02258113
org study id: T109/2014
nct id: NCT02258113
lead sponsor: 
The aim of this study is to measure visual acuity, contrast sensitivity and visual field by
      SAP-method using a novel device Ocusweep compared to currently widely used methods. Addition
      to that, the aim is to validate a novel perimetry method (Visual Search Test, VST) which is
      based on reaction times in visual decision- making task, where the subject is allowed to move
      eyes and where the fixation is verified by the subject himself in contrast to standard
      automatic perimetry (SAP) where prolonged stationary fixation and external fixation
      monitoring apparatus is required. Reaction-time based visual field device Ocusweep is
      compared to generally used SAP methods. Those tests will be done for healthy volunteers and
      for persons with diagnosed eye or brain disease.

      Ocusweep OcuRT vision based choice reaction time test is validated for test repeatability and
      compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS)
      reaction time tests. To evaluate the ability to detect unreliable results, OcuRT test is also
      done under cognitive load and with instructions to cheat the test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Visual acuity
time frame: One visit per one patient (1h/visit)
description: Visual acuity is measured as logMAR unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.
measure: Contrast sensitivity
time frame: One visit per one patient (1h/visit)
description: Contrast sensitivity is measured as logCS unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.
measure: Reaction time visual field
time frame: One visit per one patient (1h/visit)
description: Reaction time is measured using a novel reaction-time based visual field device and compared with generally used visual field program.
measure: Vision based choice reaction time
time frame: One visit per one test subject (1h/visit)
description: Reaction time is measured with Ocusweep OcuRT test three times to asses repeatability of the test. OcuRT reaction time results will be compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT will also be done under cognitive load and with instructions to cheat the test.
arm group label: LEA numbers, Pelli-Robson, Octopus
arm group type: Other
description: Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field.
intervention type: Device
intervention name: Ocusweep
description: A novel reaction-time based visual field device.
arm group label: LEA numbers, Pelli-Robson, Octopus
intervention type: Device
intervention name: Ocusweep OcuRT
description: Vision based choice reaction time test method
arm group label: LEA numbers, Pelli-Robson, Octopus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Markku Leinonen, Dr
email: markku.leinonen@ocuspecto.com
last name: Jaakko Suominen, MSc
email: jaakko.suominen@ocuspecto.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Finland
responsible party type: Sponsor
mesh term: Vision Disorders
mesh term: Vision, Low