<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/NCT02983305</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00110408</org_study_id>
    <nct_id>NCT02983305</nct_id>
  </id_info>
  <brief_title>Optical Head-Mounted Display Technology for Low Vision Rehabilitation</brief_title>
  <official_title>Optical Head-Mounted Display Technology for Low Vision Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to examine the ability of optical head-mounted display technology&#xD;
      to enlarge the visual field of patients with severe visual field loss due to retinal&#xD;
      dystrophy and to improve mobility and patient-reported outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Worldwide it is estimated that 191 million people have moderate to severe visual impairment&#xD;
      (MSVI) and an additional 32.4 million are blind. Patients with uncorrectable MSVI may undergo&#xD;
      low vision rehabilitation (LVR), which has been shown to improve functional abilities, such&#xD;
      as mobility. However, existing LVR strategies do not adequately address severe visual field&#xD;
      constriction.&#xD;
&#xD;
      In this pilot study, the investigators will test the hypothesis that optical head-mounted&#xD;
      display (HMD) technology expands constricted visual fields and improves mobility outcomes for&#xD;
      patients with retinal dystrophy. We will use the Moverio HMD platform which is considered a&#xD;
      non-significant risk device. Outcomes for patients with retinal dystrophy will be compared to&#xD;
      normal age-matched controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)</measure>
    <time_frame>Baseline and two to four weeks</time_frame>
    <description>Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.&#xD;
Average of both eyes visual fields with intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Speed Compared to Baseline (Measured in Seconds)</measure>
    <time_frame>Baseline and two to four weeks</time_frame>
    <description>Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.&#xD;
Average of data from both feet with intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Retinal Dystrophies</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Retinal Dystrophy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Age-Matched Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Head-Mounted Display</intervention_name>
    <description>Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
    <arm_group_label>Healthy Age-Matched Controls</arm_group_label>
    <arm_group_label>Retinal Dystrophy</arm_group_label>
    <other_name>Epson Moverio</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for subjects with retinal dystrophy:&#xD;
&#xD;
          -  diagnosis of retinal dystrophy&#xD;
&#xD;
          -  severe vision loss that constitutes legal blindness&#xD;
&#xD;
          -  able to perform a reliable Goldmann visual field test&#xD;
&#xD;
          -  constricted visual field less than or equal to 20 degrees by Goldmann perimetry using&#xD;
             the III4e stimulus in at least one eye with best-corrected visual acuity ≥ 20/60&#xD;
&#xD;
        Inclusion criteria for control subjects:&#xD;
&#xD;
          -  healthy controls&#xD;
&#xD;
          -  visit history with the Comprehensive and Pediatric Ophthalmology Services at the&#xD;
             University of Michigan&#xD;
&#xD;
          -  able to perform a reliable Goldmann visual field test&#xD;
&#xD;
        Exclusion criteria for subjects with retinal dystrophy:&#xD;
&#xD;
          -  movement disorder that precludes evaluation of mobility&#xD;
&#xD;
          -  functional vision loss&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
        Exclusion criteria for control subjects:&#xD;
&#xD;
          -  visually significant ocular condition other than correctable refractive error&#xD;
&#xD;
          -  movement disorder that precludes evaluation of mobility&#xD;
&#xD;
          -  functional vision loss&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua R Ehrlich, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>August 23, 2019</results_first_submitted>
  <results_first_submitted_qc>September 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2019</results_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Joshua Ehrlich</investigator_full_name>
    <investigator_title>Professor</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>Retinal Dystrophies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>June 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02983305/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Retinal Dystrophy</title>
          <description>Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
        </group>
        <group group_id="P2">
          <title>Healthy Age-Matched Controls</title>
          <description>Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>incomplete data</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Retinal Dystrophy</title>
          <description>Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
        </group>
        <group group_id="B2">
          <title>Healthy Age-Matched Controls</title>
          <description>Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.5" lower_limit="23" upper_limit="37"/>
                    <measurement group_id="B2" value="33" lower_limit="23.5" upper_limit="39.75"/>
                    <measurement group_id="B3" value="33.5" lower_limit="23" upper_limit="39.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Visual Field Area</title>
          <description>Average of both eyes visual fields at baseline (no intervention).</description>
          <units>degrees^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="568.96" lower_limit="232.40" upper_limit="742.94"/>
                    <measurement group_id="B2" value="19280.09" lower_limit="18441.30" upper_limit="19388.97"/>
                    <measurement group_id="B3" value="19009.42" lower_limit="12235.76" upper_limit="19355.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gait Speed</title>
          <description>Average of both feet at baseline (no intervention).</description>
          <units>meters per second</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.27" lower_limit="1.10" upper_limit="1.31"/>
                    <measurement group_id="B2" value="1.25" lower_limit="1.21" upper_limit="1.42"/>
                    <measurement group_id="B3" value="1.26" lower_limit="1.15" upper_limit="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)</title>
        <description>Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.&#xD;
Average of both eyes visual fields with intervention.</description>
        <time_frame>Baseline and two to four weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Retinal Dystrophy</title>
            <description>Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Age-Matched Controls</title>
            <description>Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)</title>
          <description>Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.&#xD;
Average of both eyes visual fields with intervention.</description>
          <units>degrees^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="563.08" lower_limit="331.97" upper_limit="715.60"/>
                    <measurement group_id="O2" value="-3799.19" lower_limit="-4482.99" upper_limit="-2598.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test of equivalence of visual field area at baseline.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.</non_inferiority_desc>
            <p_value>.0001</p_value>
            <p_value_desc>P &lt; .05 was considered a priori to be statistically significant.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test of equivalence of visual field area under intervention conditions.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.</non_inferiority_desc>
            <p_value>0.0001</p_value>
            <p_value_desc>P &lt; .05 was considered a priori to be statistically significant.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.</non_inferiority_desc>
            <p_value>.003</p_value>
            <p_value_desc>P &lt; .05 was considered a priori to be statistically significant.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Speed Compared to Baseline (Measured in Seconds)</title>
        <description>Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.&#xD;
Average of data from both feet with intervention.</description>
        <time_frame>Baseline and two to four weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Retinal Dystrophy</title>
            <description>Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
          </group>
          <group group_id="O2">
            <title>Healthy Age-Matched Controls</title>
            <description>Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Speed Compared to Baseline (Measured in Seconds)</title>
          <description>Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.&#xD;
Average of data from both feet with intervention.</description>
          <units>meters per second</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.01" lower_limit="-.05" upper_limit="0.00"/>
                    <measurement group_id="O2" value="-.01" lower_limit="-.05" upper_limit=".05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test of equivalence of gait speed at baseline.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.</non_inferiority_desc>
            <p_value>0.38</p_value>
            <p_value_desc>P &lt; .05 was considered a priori to be statistically significant.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test of equivalence of gait speed under intervention conditions.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.</non_inferiority_desc>
            <p_value>0.27</p_value>
            <p_value_desc>P &lt; .05 was considered a priori to be statistically significant.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between study arms of the change in the gait speed detected between baseline and intervention.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.</non_inferiority_desc>
            <p_value>0.79</p_value>
            <p_value_desc>P &lt; .05 was considered a priori to be statistically significant.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 2-4 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Retinal Dystrophy</title>
          <description>Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</description>
        </group>
        <group group_id="E2">
          <title>Healthy Age-Matched Controls</title>
          <description>Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.&#xD;
Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Sara</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-936-7567</phone>
      <email>weisssar@umich.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/NCT02983305
org study id: HUM00110408
nct id: NCT02983305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The goal of this study is to examine the ability of optical head-mounted display technology
      to enlarge the visual field of patients with severe visual field loss due to retinal
      dystrophy and to improve mobility and patient-reported outcomes.
Worldwide it is estimated that 191 million people have moderate to severe visual impairment
      (MSVI) and an additional 32.4 million are blind. Patients with uncorrectable MSVI may undergo
      low vision rehabilitation (LVR), which has been shown to improve functional abilities, such
      as mobility. However, existing LVR strategies do not adequately address severe visual field
      constriction.

      In this pilot study, the investigators will test the hypothesis that optical head-mounted
      display (HMD) technology expands constricted visual fields and improves mobility outcomes for
      patients with retinal dystrophy. We will use the Moverio HMD platform which is considered a
      non-significant risk device. Outcomes for patients with retinal dystrophy will be compared to
      normal age-matched controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)
time frame: Baseline and two to four weeks
description: Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.
Average of both eyes visual fields with intervention.
measure: Change in Gait Speed Compared to Baseline (Measured in Seconds)
time frame: Baseline and two to four weeks
description: Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.
Average of data from both feet with intervention.
arm group label: Retinal Dystrophy
arm group type: Experimental
description: Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.
arm group label: Healthy Age-Matched Controls
arm group type: Experimental
description: Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested.
intervention type: Device
intervention name: Head-Mounted Display
description: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.
arm group label: Healthy Age-Matched Controls
arm group label: Retinal Dystrophy
other name: Epson Moverio
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua R Ehrlich, MD, MPH
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Joshua Ehrlich
investigator title: Professor
mesh term: Vision, Low
mesh term: Retinal Dystrophies
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 