<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/NCT03751241</url>
  </required_header>
  <id_info>
    <org_study_id>Eyetracker</org_study_id>
    <nct_id>NCT03751241</nct_id>
  </id_info>
  <brief_title>Reading Quality in Three Different Patient Groups</brief_title>
  <official_title>Evaluation of Reading Quality in Three Different Patient Groups (Extended Range Of Vision vs Minimonovision vs Single Focus Distance Vision)</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>
      Influence of different ophthalmic conditions after cataract surgery (extended range of vision&#xD;
      IOL (EROV) with micromonovision, minimonovision with standard IOL and single focus distance&#xD;
      vision with standard IOL) on reading quality.&#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. It also slows down when the understanding&#xD;
      is difficult, which is why reading one's mother tongue generally is faster than reading a&#xD;
      foreign language. Reading skill is therefore influenced by visuo-motor and cognitive (i.e.&#xD;
      linguistic, personality, learning, ageing) factors. Reading ability is currently evaluated&#xD;
      using various reading tests, which usually have long paragraphs with small print and shorter&#xD;
      ones with larger print, to allow determination of reading acuity. To evaluate sustained&#xD;
      reading performance, and reading speed, the International Reading Speed Texts (IReST) which&#xD;
      contain longer paragraphs with continuous text of fixed size, have been developed. Although&#xD;
      clinical reading tests are thoroughly standardized, a significant inter-individual variation&#xD;
      in reading speed exists, as a result of the high influence of cognitive factors. When&#xD;
      reading, sensorimotor coordination must happen to make a sequence of fixations and saccades&#xD;
      so that new information falls onto the fovea. Eye movement efficiency develops almost in&#xD;
      parallel with reading ability, in terms of speed and accuracy, as the child progresses from a&#xD;
      beginner to a proficient adult reader. Less skilled readers (e.g. children with reading&#xD;
      difficulties) typically make more fixations of longer duration and shorter saccades than&#xD;
      skilled readers. For an adult reader mean fixation duration is around 220 to 250 ms. However,&#xD;
      fixations of variable durations (from 100 ms to over 500 ms) are recorded during a reading&#xD;
      session. Although the distribution of fixation durations varies among individuals, due to&#xD;
      differences in reading skill, age and other cognitive factors, it is never normal; it always&#xD;
      exhibits a pronounced right tail, i.e. an increased frequency of long fixations. Such&#xD;
      distributions can be fitted with an ex-Gaussian function, a convolution of Gaussian (normal)&#xD;
      and exponential functions, which could provide more efficient analysis. The team in&#xD;
      university of Crete recently showed that pre-retinal factors (e.g. text contrast and&#xD;
      luminance) influence the mean of the normal distribution, while cognitive factors affect the&#xD;
      number of fixations and the mean of the exponential distribution of fixation duration, due to&#xD;
      an increased frequency of long fixations. Moreover, inter-individual variation was&#xD;
      significantly improved when analysis was performed separately for visuo-motor vs. cognitive&#xD;
      components, with most of variability being attributed to the mean of the exponential&#xD;
      distribution.&#xD;
&#xD;
      To evaluate functional vision in &quot;simultaneous-image' correction and more specifically visual&#xD;
      performance at near, a functional outcome, such as reading speed and ocular fixation times&#xD;
      during sustained reading, should be measured. Such recordings could then answer the question&#xD;
      how the binocular improvement in reading depends on the difference in acuity between the eyes&#xD;
      and the analysis suggested above could help us to distinguish sensory vs. motor components&#xD;
      especially in patients with reduced contrast sensitivity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>Screening</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 in the 3 different IOL groups (EROV, monofocal, minimonovision) will be assessed using the EyeTracker device. Patients are asked to read 4 texts with different contrast levels. The faster the patients can read the texts, the better the outcome.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Pseudophakia</condition>
  <arm_group>
    <arm_group_label>Intraocular lens types</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with different types of IOLs (EROV, monofocal, minimonovision) are tested for their reading quality using the EyeTracker device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EyeTracker</intervention_name>
    <description>The EyeTracker is used to determine reading quality of patients with different intraocular lens types (EROV, monofocal, minimonovision)</description>
    <arm_group_label>Intraocular lens types</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Extended range of vision group: Patients with EROV intraocular lenses and a&#xD;
             best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the&#xD;
             better eye has to be at least 0.8 (uncorrected visual acuity) and the difference&#xD;
             between the eyes should be between 0.5D and 1D)&#xD;
&#xD;
          -  Minimonovision standard IOL group: Patients with monofocal intraocular lenses and a&#xD;
             best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the&#xD;
             better eye has to be at least 0.8 (uncorrected visual acuity) and the difference&#xD;
             between the eyes should be between 0.75D and 1.50D)&#xD;
&#xD;
          -  Single focus distance vision group: Patients with monofocal intraocular lenses and a&#xD;
             best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the&#xD;
             better eye has to be at least 0.8 (uncorrected visual acuity) and both eyes should&#xD;
             have a spherical equivalent between +0.25D and -0.5D&#xD;
&#xD;
          -  Maximum of allowed Cylinder: +0.75D&#xD;
&#xD;
          -  Fluent in German&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opacities, such as corneal scars&#xD;
&#xD;
          -  In case of pregnancy (pregnancy test will be taken preoperatively in women of&#xD;
             reproductive age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sahand Amir-Asgari, MD</last_name>
    <phone>01 91021-57557</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stefan Palkovits, MD</last_name>
    <phone>01 91021-57564</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>Sahand Amir-Asgari, MD</last_name>
      <phone>01 91021-57557</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Stefan Palkovits, MD</last_name>
      <phone>01 91021-57564</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 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 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>Pseudophakia</keyword>
  <keyword>Reading speed</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pseudophakia</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/NCT03751241
org study id: Eyetracker
nct id: NCT03751241
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Influence of different ophthalmic conditions after cataract surgery (extended range of vision
      IOL (EROV) with micromonovision, minimonovision with standard IOL and single focus distance
      vision with standard IOL) on reading quality.
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. It also slows down when the understanding
      is difficult, which is why reading one's mother tongue generally is faster than reading a
      foreign language. Reading skill is therefore influenced by visuo-motor and cognitive (i.e.
      linguistic, personality, learning, ageing) factors. Reading ability is currently evaluated
      using various reading tests, which usually have long paragraphs with small print and shorter
      ones with larger print, to allow determination of reading acuity. To evaluate sustained
      reading performance, and reading speed, the International Reading Speed Texts (IReST) which
      contain longer paragraphs with continuous text of fixed size, have been developed. Although
      clinical reading tests are thoroughly standardized, a significant inter-individual variation
      in reading speed exists, as a result of the high influence of cognitive factors. When
      reading, sensorimotor coordination must happen to make a sequence of fixations and saccades
      so that new information falls onto the fovea. Eye movement efficiency develops almost in
      parallel with reading ability, in terms of speed and accuracy, as the child progresses from a
      beginner to a proficient adult reader. Less skilled readers (e.g. children with reading
      difficulties) typically make more fixations of longer duration and shorter saccades than
      skilled readers. For an adult reader mean fixation duration is around 220 to 250 ms. However,
      fixations of variable durations (from 100 ms to over 500 ms) are recorded during a reading
      session. Although the distribution of fixation durations varies among individuals, due to
      differences in reading skill, age and other cognitive factors, it is never normal; it always
      exhibits a pronounced right tail, i.e. an increased frequency of long fixations. Such
      distributions can be fitted with an ex-Gaussian function, a convolution of Gaussian (normal)
      and exponential functions, which could provide more efficient analysis. The team in
      university of Crete recently showed that pre-retinal factors (e.g. text contrast and
      luminance) influence the mean of the normal distribution, while cognitive factors affect the
      number of fixations and the mean of the exponential distribution of fixation duration, due to
      an increased frequency of long fixations. Moreover, inter-individual variation was
      significantly improved when analysis was performed separately for visuo-motor vs. cognitive
      components, with most of variability being attributed to the mean of the exponential
      distribution.

      To evaluate functional vision in "simultaneous-image' correction and more specifically visual
      performance at near, a functional outcome, such as reading speed and ocular fixation times
      during sustained reading, should be measured. Such recordings could then answer the question
      how the binocular improvement in reading depends on the difference in acuity between the eyes
      and the analysis suggested above could help us to distinguish sensory vs. motor components
      especially in patients with reduced contrast sensitivity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Reading speed
time frame: 12 months
description: Reading speed in the 3 different IOL groups (EROV, monofocal, minimonovision) will be assessed using the EyeTracker device. Patients are asked to read 4 texts with different contrast levels. The faster the patients can read the texts, the better the outcome.
arm group label: Intraocular lens types
arm group type: Experimental
description: Patients with different types of IOLs (EROV, monofocal, minimonovision) are tested for their reading quality using the EyeTracker device
intervention type: Device
intervention name: EyeTracker
description: The EyeTracker is used to determine reading quality of patients with different intraocular lens types (EROV, monofocal, minimonovision)
arm group label: Intraocular lens types
criteria: 
gender: All
minimum age: 21 Years
maximum age: 110 Years
healthy volunteers: No
last name: Sahand Amir-Asgari, MD
phone: 01 91021-57557
email: office@viros.at
last name: Stefan Palkovits, MD
phone: 01 91021-57564
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: Pseudophakia
sharing ipd: Undecided