<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/NCT03794752</url>
  </required_header>
  <id_info>
    <org_study_id>STU 012014-015</org_study_id>
    <nct_id>NCT03794752</nct_id>
  </id_info>
  <brief_title>Visual Enhancement Device in Low Vision Patients</brief_title>
  <acronym>Evergaze</acronym>
  <official_title>Evaluation of a Head Mounted Electronic Visual Enhancement Device in Low Vision Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a prospective, non-randomized study of low-vision individuals diagnosed&#xD;
      with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS&#xD;
      visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern&#xD;
      (UTSW) Medical Center at Dallas. Specifically, the primary objective of this testing is to&#xD;
      establish the benefits of a wide field-of-view (FOV) monocular head-mounted visual&#xD;
      enhancement device display (HMD), aiding the most degraded eye, as compared to best corrected&#xD;
      visual acuity with glasses. It should be noted that in this approach, the HMD incorporates a&#xD;
      camera, mounted coaxially with the visual axis of the eye with worse vision, and also&#xD;
      image-enhancing or correction algorithms. Following review and execution of the informed&#xD;
      consent, each subject will undergo an examination of their eyes, including: 1) ETDRS&#xD;
      Best-corrected distance visual acuity; 2) Best-corrected near visual acuity; 3) Tests based&#xD;
      on questions 5,6,7 and 11 of the National Eye Institute 25-item visual function questionnaire&#xD;
      (NEI VFQ-25).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single visit, prospective, non-randomized study of low vision individuals diagnosed with&#xD;
      Age Related Macular Degeneration or Diabetic macular edema research project is designed to&#xD;
      last about 1.5 hours. All testing will be used for research purposes. There will be an 1)&#xD;
      Early Treatment Diabetic Retinopathy Study visual acuity test, 2) near vision test, 3)&#xD;
      Testing based on questions 5,6,7, and 11 of the National Eye Institute 25 item visual&#xD;
      function questionnaire, (NEI VFQ-25) which includes a speed reading test, identifying&#xD;
      objects, physically taking them and returning the items to correct original placement, once&#xD;
      with glasses only, once with the head mounted visual device placed over the worst eye&#xD;
      visually. There will also be an video tracks showing a conversation between 2 individuals -&#xD;
      Subjects will be queried about the facial expressions of the actors during the conversation.&#xD;
      The device is a wide field of view (FOV) monocular head-mounted visual enhancement device&#xD;
      (HMD). The HMD has a camera mounted coaxially with the visual axis of the worse vision eye,&#xD;
      and also image enhancing or correction algorithms. There are breaks planned between testing&#xD;
      on the visual function exam portion of the NEI-25.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 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>
    <intervention_model_description>Participants will wear a head mounted visual enhancement device.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device</measure>
    <time_frame>5 minutes post intervention</time_frame>
    <description>ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.&#xD;
The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device</measure>
    <time_frame>10 minutes post intervention</time_frame>
    <description>ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device</measure>
    <time_frame>Day 1 up to 6 minutes post intervention</time_frame>
    <description>Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.</measure>
    <time_frame>Day 1 up to 1 minute post intervention</time_frame>
    <description>Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device</measure>
    <time_frame>Initial Baseline and 3 minutes</time_frame>
    <description>Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Macular Degeneration, Age-Related</condition>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>Vision Aided by a Head Mounted Device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A Head-Mounted Visual Enhancement Device developed by Evergaze Technology LLC has designed an electronic visual enhancement device that is compact and similar to glasses. It will be powered by a battery pack connected to the device. The electronic display will be affixed over only one of the user's eyes. The vision through the unobstructed eye will aid with the subject's balance and spatial orientation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Head-Mounted Visual Enhancement Device</intervention_name>
    <description>Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black &amp; white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).</description>
    <arm_group_label>Vision Aided by a Head Mounted Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient of any sex, race, or ethnicity who are 18 years of age or older. Spanish&#xD;
             speaking patients will be encouraged to participate, Spanish forms will be available&#xD;
             to review and execute.&#xD;
&#xD;
          -  Patient willing to review, understand and sign written informed consent. Parents or&#xD;
             legal guardians will consent on behalf of minors.&#xD;
&#xD;
          -  Written authorization for use or release of health and research study information.&#xD;
&#xD;
          -  Patient who volunteers is suffering from a posterior segment ophthalmic disorder&#xD;
             including AMD and/or Diabetic Retinopathy and visual acuity from 20/60 to 20/400 in&#xD;
             the better seeing eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded if they are less than 18 years of age.&#xD;
&#xD;
          -  Subjects will not be considered for this research study if they will not review and&#xD;
             execute the informed consent form.&#xD;
&#xD;
          -  During the screening process, subjects will be excluded from further consideration if&#xD;
             they are identified with having a potential ophthalmic diagnosis other than&#xD;
             age-related macular degeneration or diabetic macular edema that could be negatively&#xD;
             affecting the visual testing.&#xD;
&#xD;
          -  ETDRS Visual Acuity better than 20/60 or worse than 20/400&#xD;
&#xD;
          -  During screening, subjects will be disqualified from further assessment if it is&#xD;
             determined that their refractive error is outside of the -5.00 to +5.00 D corrective&#xD;
             range.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafael Ufret-Vincenty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTSW Medical Center</affiliation>
  </overall_official>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <results_first_submitted>September 24, 2020</results_first_submitted>
  <results_first_submitted_qc>December 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2021</results_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Rafael Ufret-Vincenty</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision, Low</mesh_term>
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03794752/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Use of Head Mounted Device</title>
          <description>Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400.&#xD;
The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants performing skills without the head mounted visual aid device will be provide the baseline values for each aspect of this study.</population>
      <group_list>
        <group group_id="B1">
          <title>Vision Aided by a Head Mounted Device</title>
          <description>Head-Mounted Visual Enhancement Device: Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black &amp; white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Rows represent Race and Ethnicity.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Non-HIspanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device</title>
        <description>ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.&#xD;
The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
        <time_frame>5 minutes post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vision Aided by a Head Mounted Device</title>
            <description>ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions.&#xD;
1. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device</title>
          <description>ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.&#xD;
The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>BCVA unable to read</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCVA &lt;/= 20/50</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCVA &lt;/= 20/80</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCVA &gt; 20/350</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device</title>
        <description>ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
        <time_frame>10 minutes post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vision Aided by a Head Mounted Device</title>
            <description>ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected near visual acuity (BCNVA) will be determined for each participant using the following conditions.&#xD;
1. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device</title>
          <description>ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>BCVNA Unable to read</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCVNA &lt;=20/50</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCVNA &lt;=20/150</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCVNA &gt; 20/150</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device</title>
        <description>Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.</description>
        <time_frame>Day 1 up to 6 minutes post intervention</time_frame>
        <population>Participants were asked to read a passage 98 words within a 3 min. time period</population>
        <group_list>
          <group group_id="O1">
            <title>Vision Aided by a Head Mounted Device</title>
            <description>Reading speed is measured by using a standard paragraph. English Paragraph Reference: 3-Minute Reading Assessments, Rasinski TV and Padak N, 2005. Scholastic Inc., NY.&#xD;
This outcome examines change in reading speed of the participant in two separate conditions:&#xD;
1. Baseline reading - no use of the head-mounted electronic visual enhancement device. and 2. reading using head-mounted electronic visual enhancement device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device</title>
          <description>Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.</description>
          <population>Participants were asked to read a passage 98 words within a 3 min. time period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Completed reading assignment with device</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Did not complete reading assignment with device</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.</title>
        <description>Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
        <time_frame>Day 1 up to 1 minute post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vision Aided by a Head Mounted Device</title>
            <description>Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions will be determined for each participant using the following conditions.&#xD;
1. Using the head-mounted electronic visual enhancement device. 2. Without using the head-mounted electronic visual enhancement device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.</title>
          <description>Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Able to distinguish expressions w/ device</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to distinguish expressions w/ device</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device</title>
        <description>Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
        <time_frame>Initial Baseline and 3 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vision Aided by a Head Mounted Device</title>
            <description>Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded. Data will record change in response speed to identify shapes and objects under 2 conditions; 1. with the participant using the head-mounted electronic visual enhancement device and 2. with the participant not using the head-mounted electronic visual enhancement device .</description>
          </group>
        </group_list>
        <measure>
          <title>Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device</title>
          <description>Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device.&#xD;
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Identify items with device &lt; 15 sec w/ headset</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Identify items with device &gt; 15 sec w/ headset</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cannot identify items w/ headset</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Use of Head Mounted Device</title>
          <description>Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400.&#xD;
The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study had a small enrollment of 8 initial pilot study participants that were tested but not analyzed due to an early termination of the study. Termination was due to irreconcilable differences regarding intellectual property.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Peter Chen</name_or_title>
      <organization>UT Southwestern Medical Center</organization>
      <phone>12146283837</phone>
      <email>peter.chen@utsouthwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03794752
org study id: STU 012014-015
nct id: NCT03794752
lead sponsor: 
has dmc: No
This study will be a prospective, non-randomized study of low-vision individuals diagnosed
      with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS
      visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern
      (UTSW) Medical Center at Dallas. Specifically, the primary objective of this testing is to
      establish the benefits of a wide field-of-view (FOV) monocular head-mounted visual
      enhancement device display (HMD), aiding the most degraded eye, as compared to best corrected
      visual acuity with glasses. It should be noted that in this approach, the HMD incorporates a
      camera, mounted coaxially with the visual axis of the eye with worse vision, and also
      image-enhancing or correction algorithms. Following review and execution of the informed
      consent, each subject will undergo an examination of their eyes, including: 1) ETDRS
      Best-corrected distance visual acuity; 2) Best-corrected near visual acuity; 3) Tests based
      on questions 5,6,7 and 11 of the National Eye Institute 25-item visual function questionnaire
      (NEI VFQ-25).
A single visit, prospective, non-randomized study of low vision individuals diagnosed with
      Age Related Macular Degeneration or Diabetic macular edema research project is designed to
      last about 1.5 hours. All testing will be used for research purposes. There will be an 1)
      Early Treatment Diabetic Retinopathy Study visual acuity test, 2) near vision test, 3)
      Testing based on questions 5,6,7, and 11 of the National Eye Institute 25 item visual
      function questionnaire, (NEI VFQ-25) which includes a speed reading test, identifying
      objects, physically taking them and returning the items to correct original placement, once
      with glasses only, once with the head mounted visual device placed over the worst eye
      visually. There will also be an video tracks showing a conversation between 2 individuals -
      Subjects will be queried about the facial expressions of the actors during the conversation.
      The device is a wide field of view (FOV) monocular head-mounted visual enhancement device
      (HMD). The HMD has a camera mounted coaxially with the visual axis of the worse vision eye,
      and also image enhancing or correction algorithms. There are breaks planned between testing
      on the visual function exam portion of the NEI-25.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will wear a head mounted visual enhancement device.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device
time frame: 5 minutes post intervention
description: ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.
The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
measure: Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device
time frame: 10 minutes post intervention
description: ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
measure: Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device
time frame: Day 1 up to 6 minutes post intervention
description: Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.
measure: Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.
time frame: Day 1 up to 1 minute post intervention
description: Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device.
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
measure: Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device
time frame: Initial Baseline and 3 minutes
description: Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device.
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
arm group label: Vision Aided by a Head Mounted Device
arm group type: Other
description: A Head-Mounted Visual Enhancement Device developed by Evergaze Technology LLC has designed an electronic visual enhancement device that is compact and similar to glasses. It will be powered by a battery pack connected to the device. The electronic display will be affixed over only one of the user's eyes. The vision through the unobstructed eye will aid with the subject's balance and spatial orientation.
intervention type: Device
intervention name: Head-Mounted Visual Enhancement Device
description: Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black & white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).
arm group label: Vision Aided by a Head Mounted Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rafael Ufret-Vincenty, MD
role: Principal Investigator
affiliation: UTSW Medical Center
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Rafael Ufret-Vincenty
investigator title: Associate Professor of Medicine
mesh term: Vision, Low
mesh term: Macular Degeneration
mesh term: Diabetic Retinopathy
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study had a small enrollment of 8 initial pilot study participants that were tested but not analyzed due to an early termination of the study. Termination was due to irreconcilable differences regarding intellectual property.
point of contact: 