<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/NCT03270865</url>
  </required_header>
  <id_info>
    <org_study_id>Notal U-001 V. 1.0</org_study_id>
    <nct_id>NCT03270865</nct_id>
  </id_info>
  <brief_title>Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging</brief_title>
  <official_title>Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Notal Vision Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Notal Vision Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study &quot;Usability and Ergonomic Evaluation of Self-Positioning System for&#xD;
      Retinal Imaging&quot; is to enable self-operation of a monitoring device in home-simulated&#xD;
      environment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the main challenges in developing a retinal imager is to design it to be self-operated&#xD;
      by elderly patients in their home setting The study's objective is to explore ergonomic&#xD;
      solutions that will allow the user to perform imaging on their own. The study will be done in&#xD;
      a home-simulated environment using a dedicated ergonomic system (termed &quot;PAF&quot; - Positioning&#xD;
      And Fixation system) that stimulates the retinal imager and enables to record the tested&#xD;
      subject using standard cameras. The prototype doesn't include the retinal imager and does not&#xD;
      include any imaging capabilities aside from standard means of photography Subjects will be&#xD;
      evaluating for positioning accuracy and comfort by comparing different methods. Pupil&#xD;
      position will be recorded using commercial off the shelf cameras when the subject is&#xD;
      performing simple ergonomic tasks while looking at a screen presenting images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>spatial location of the pupil, during an eye examination</measure>
    <time_frame>1 year</time_frame>
    <description>documentation of pupil location by a camera</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>AMD Population - Intermediate or Advanced AMD</condition>
  <condition>DR Population- With or Without Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Usability and Ergonomic Evaluation of Self-Positioning System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PAF (Positioning And Fixation device)</intervention_name>
    <description>Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation.&#xD;
The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded.&#xD;
Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes.</description>
    <arm_group_label>Usability and Ergonomic Evaluation of Self-Positioning System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 65&#xD;
&#xD;
          -  Able to understand and sign the informed consent form&#xD;
&#xD;
          -  Ability to communicate verbally&#xD;
&#xD;
          -  AMD (interim and advanced) or diabetic retinopathy (with and without DME)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual acuity &gt;=20/200 in the better eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sorasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2019</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>Macular Edema</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/NCT03270865
org study id: Notal U-001 V. 1.0
nct id: NCT03270865
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for
      Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated
      environment
One of the main challenges in developing a retinal imager is to design it to be self-operated
      by elderly patients in their home setting The study's objective is to explore ergonomic
      solutions that will allow the user to perform imaging on their own. The study will be done in
      a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning
      And Fixation system) that stimulates the retinal imager and enables to record the tested
      subject using standard cameras. The prototype doesn't include the retinal imager and does not
      include any imaging capabilities aside from standard means of photography Subjects will be
      evaluating for positioning accuracy and comfort by comparing different methods. Pupil
      position will be recorded using commercial off the shelf cameras when the subject is
      performing simple ergonomic tasks while looking at a screen presenting images.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: spatial location of the pupil, during an eye examination
time frame: 1 year
description: documentation of pupil location by a camera
arm group label: Usability and Ergonomic Evaluation of Self-Positioning System
arm group type: Experimental
intervention type: Device
intervention name: PAF (Positioning And Fixation device)
description: Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation.
The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded.
Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes.
arm group label: Usability and Ergonomic Evaluation of Self-Positioning System
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Macular Edema