<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/NCT03750149</url>
  </required_header>
  <id_info>
    <org_study_id>TRC</org_study_id>
    <nct_id>NCT03750149</nct_id>
  </id_info>
  <brief_title>Reading Analysis in Ophthalmologic Patients</brief_title>
  <official_title>Reading Analysis in Ophthalmologic Patients: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of the reading parameters and fixation behavior in patients with different&#xD;
      ocular diseases (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal&#xD;
      membrane) and healthy subjects. In addition, fixation analysis and retinal sensitivity&#xD;
      measurements will be done with a microperimeter in each subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reading is a complex function. It requires a proper retinal image that is received by the&#xD;
      brain. There it is analyzed for letter and word recognition and then the semantics is&#xD;
      detected. Reading speed slows down when letters are blurred, or do not have enough contrast&#xD;
      or luminance or when binocular fusion is hampered. Hence, it is obvious that reading ability&#xD;
      is reduced in patients with various ocular diseases. Especially, pathologies effecting the&#xD;
      posterior pole (central and paracentral vision) might impair reading parameters&#xD;
      significantly.&#xD;
&#xD;
      Recently, the Eyetracker Eyelink 1000 (SR Research Ltd, Canada) became available. It´s&#xD;
      application was described previously. Briefly, a high-speed infrared camera detects the&#xD;
      position of eye (pupil and corneal reflex) and in turn the direction of gaze 500 times per&#xD;
      second. During the calibration process the position can be linked to the position on a screen&#xD;
      where, for instance, a text or a fixation target can be projected. Direction of gaze is&#xD;
      recorded during the reading process and the gathered data are analyzed.&#xD;
&#xD;
      Fixation ability was assessed using Eyelink 1000 in patients with age-related macular&#xD;
      degeneration. It was shown that fixation is related to visual function. The worse eye showed&#xD;
      reduced fixation ability which is improved during binocular fixation. This study investigates&#xD;
      reading parameters in patients with various ocular diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reading speed</measure>
    <time_frame>12 months</time_frame>
    <description>Reading speed (words per minute) will be analysed using the EyeTracker device. The patient has to read 4 texts with different contrast levels. The faster the patient can read a text, the better the results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retinal perimetry</measure>
    <time_frame>12 months</time_frame>
    <description>Analysis of retinal fixation will be done using microperimetry.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetic Maculopathy</condition>
  <condition>Age Related Macular Degeneration</condition>
  <condition>Glaucoma</condition>
  <condition>Epiretinal Membrane</condition>
  <arm_group>
    <arm_group_label>Ophthalmologic Disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with glaucoma, AMD, diabetic maculopathy, epiretinal membranes, and healthy patients will undergo a reading analysis using the EyeTracker</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EyeTracker</intervention_name>
    <description>Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker</description>
    <arm_group_label>Ophthalmologic Disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Absence of ocular disease (Group 1)&#xD;
&#xD;
          -  Present ocular disease (age-related macular degeneration, glaucoma, diabetic&#xD;
             maculopathy, epiretinal membrane/macular hole) as judged by the investigator (Group 2&#xD;
             - 5)&#xD;
&#xD;
          -  Maximum of allowed cylinder-power in the spectacles: +1.50D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ocular pathologies, that may interfere with study measurements, such as corneal scars&#xD;
&#xD;
          -  In case of pregnancy (pregnancy test will be taken prior to inclusion into the study&#xD;
             in women of reproductive age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Stefan Palkovits, MD</last_name>
    <phone>01 910 21-57573</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sahand Amir-Asgari, MD</last_name>
    <phone>01 910 21-57557</phone>
    <email>office@viros.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS)</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Palkovits, MD</last_name>
      <phone>01 910 21-57573</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Sahand Amir-Asgari, MD</last_name>
      <phone>01 910 21-57557</phone>
      <email>office@viros.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetic Maculopathy</keyword>
  <keyword>Age Related Macular Degeneration</keyword>
  <keyword>Glaucoma</keyword>
  <keyword>Epiretinal membrane</keyword>
  <keyword>Reading analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Epiretinal Membrane</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03750149
org study id: TRC
nct id: NCT03750149
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Investigation of the reading parameters and fixation behavior in patients with different
      ocular diseases (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal
      membrane) and healthy subjects. In addition, fixation analysis and retinal sensitivity
      measurements will be done with a microperimeter in each subject.
Reading is a complex function. It requires a proper retinal image that is received by the
      brain. There it is analyzed for letter and word recognition and then the semantics is
      detected. Reading speed slows down when letters are blurred, or do not have enough contrast
      or luminance or when binocular fusion is hampered. Hence, it is obvious that reading ability
      is reduced in patients with various ocular diseases. Especially, pathologies effecting the
      posterior pole (central and paracentral vision) might impair reading parameters
      significantly.

      Recently, the Eyetracker Eyelink 1000 (SR Research Ltd, Canada) became available. It´s
      application was described previously. Briefly, a high-speed infrared camera detects the
      position of eye (pupil and corneal reflex) and in turn the direction of gaze 500 times per
      second. During the calibration process the position can be linked to the position on a screen
      where, for instance, a text or a fixation target can be projected. Direction of gaze is
      recorded during the reading process and the gathered data are analyzed.

      Fixation ability was assessed using Eyelink 1000 in patients with age-related macular
      degeneration. It was shown that fixation is related to visual function. The worse eye showed
      reduced fixation ability which is improved during binocular fixation. This study investigates
      reading parameters in patients with various ocular diseases.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Reading speed
time frame: 12 months
description: Reading speed (words per minute) will be analysed using the EyeTracker device. The patient has to read 4 texts with different contrast levels. The faster the patient can read a text, the better the results.
measure: Retinal perimetry
time frame: 12 months
description: Analysis of retinal fixation will be done using microperimetry.
arm group label: Ophthalmologic Disease
arm group type: Experimental
description: Patients with glaucoma, AMD, diabetic maculopathy, epiretinal membranes, and healthy patients will undergo a reading analysis using the EyeTracker
intervention type: Device
intervention name: EyeTracker
description: Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker
arm group label: Ophthalmologic Disease
criteria: 
gender: All
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Palkovits, MD
phone: 01 910 21-57573
email: office@viros.at
last name: Sahand Amir-Asgari, MD
phone: 01 910 21-57557
email: office@viros.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Principal Investigator
mesh term: Glaucoma
mesh term: Macular Degeneration
mesh term: Epiretinal Membrane
sharing ipd: Undecided