<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/NCT03804684</url>
  </required_header>
  <id_info>
    <org_study_id>IRB Control #18-768E</org_study_id>
    <nct_id>NCT03804684</nct_id>
  </id_info>
  <brief_title>visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry</brief_title>
  <official_title>How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Olleyes, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wills Eye</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal&#xD;
      sensitivity and to assess the repeatability of the measured values and compare them with&#xD;
      those measured by a Standard Automatic Perimetry (SAP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central&#xD;
      and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases&#xD;
      such as glaucoma. The current device has its own limitation such as positioning for the&#xD;
      duration of the test which makes is hard for older patients especially those with back or&#xD;
      other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the&#xD;
      patients refractive errors, etc.&#xD;
&#xD;
      Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the&#xD;
      Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient&#xD;
      comfort.&#xD;
&#xD;
      The main goal of this study is to evaluate the repeatability of a novel psychophysical&#xD;
      platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities.&#xD;
      Other objectives of this study include the development of an initial reference database and&#xD;
      comparison of the measured parameters with HFA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Retinal Sensitivity From Two Machines</measure>
    <time_frame>three hours</time_frame>
    <description>Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Correlation (Agreement Between Two Machines in the Overall Visual Field)</measure>
    <time_frame>three hours</time_frame>
    <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)</measure>
    <time_frame>three hours</time_frame>
    <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field</measure>
    <time_frame>three hours</time_frame>
    <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild and Moderate Glaucoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard Automatic Perimetry Humphrey Field Analyzer</intervention_name>
    <description>Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.</description>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Mild and Moderate Glaucoma</arm_group_label>
    <other_name>SAP HFA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>visuALL Field Analyzer</intervention_name>
    <description>visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.</description>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Mild and Moderate Glaucoma</arm_group_label>
    <other_name>vFA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 21 to 80 years&#xD;
&#xD;
          -  Healthy subjects with no eye diseases, normal appearing optic nerve and retina,&#xD;
             intraocular pressure less than 19 millimeters mercury and normal standard automatic&#xD;
             perimetry (SAP).&#xD;
&#xD;
          -  mild glaucoma subjects with less than -6 mean deviation&#xD;
&#xD;
          -  moderate glaucoma subjects with -6 to -12 mean deviation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0&#xD;
             diopters&#xD;
&#xD;
          -  Unreliable SAP (false positives, fixation losses and false negatives greater than 25%&#xD;
             and/or observable testing artifacts)&#xD;
&#xD;
          -  Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive&#xD;
             fixation losses)&#xD;
&#xD;
          -  SAP abnormality with pattern loss consistent with neurologic and/or other ocular&#xD;
             diseases than glaucoma&#xD;
&#xD;
          -  Intraocular surgery in study eye (except non-complicated cataract or refractive&#xD;
             surgery performed more than 6 months before enrollment and without posterior capsule&#xD;
             opacification)&#xD;
&#xD;
          -  History of systemic condition known to affect visual function&#xD;
&#xD;
          -  History of medication known to affect visual function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M Reza Razeghinejad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wills Eye</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.</citation>
    <PMID>32941320</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <results_first_submitted>January 10, 2022</results_first_submitted>
  <results_first_submitted_qc>June 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2022</results_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>M. Reza Razeghinejad MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>open angle glaucoma</keyword>
  <keyword>visual field</keyword>
  <keyword>Standard Automatic Perimetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</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>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03804684/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Glaucoma patients with mild or moderate visual field loss and subjects with healthy vision were enrolled to form two groups for comparison of two methods of visual field testing. Subjects unable to perform testing or test reliability did not meet inclusion criteria in 3 of the Healthy Controls and 18 of the Glaucoma Group. Therefore, 21 participants were excluded from results.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy Controls</title>
          <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
        </group>
        <group group_id="P2">
          <title>Glaucoma Group</title>
          <description>Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subjects unable to perform testing or test reliability did not meet inclusion criteria.</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Controls</title>
          <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.&#xD;
Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.&#xD;
visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.</description>
        </group>
        <group group_id="B2">
          <title>Glaucoma Group</title>
          <description>Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.&#xD;
Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.&#xD;
visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.</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="28"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="72"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mild to Moderate Glaucoma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of eyes analyzed</title>
          <units>number of eyes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>total eyes analyzed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>eyes with mild visual field defects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>eyes with moderate visual field defects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>eyes with severe visual field defects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Retinal Sensitivity From Two Machines</title>
        <description>Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.</description>
        <time_frame>three hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Controls</title>
            <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Fifty eyes with normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
          <group group_id="O2">
            <title>Glaucoma Group</title>
            <description>Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Retinal Sensitivity From Two Machines</title>
          <description>Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.</description>
          <units>decibels</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global field from Humphrey Visual Field</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.9" spread="1.4"/>
                    <measurement group_id="O2" value="24.8" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global field from VisuALL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" spread="1.3"/>
                    <measurement group_id="O2" value="22.9" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inferior nasal quadrant from Humphrey Visual Field</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3" spread="1.3"/>
                    <measurement group_id="O2" value="24.8" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inferior nasal quadrant from VisuALL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" spread="1.6"/>
                    <measurement group_id="O2" value="23.3" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superior hemifield from Humphrey Visual Field</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" spread="1.5"/>
                    <measurement group_id="O2" value="23.7" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superior hemifield from VisuALL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" spread="1.6"/>
                    <measurement group_id="O2" value="21.8" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Global Correlation (Agreement Between Two Machines in the Overall Visual Field)</title>
        <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.</description>
        <time_frame>three hours</time_frame>
        <population>The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their visual field (overall).</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Controls</title>
            <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
          <group group_id="O2">
            <title>Glaucoma Group</title>
            <description>Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Correlation (Agreement Between Two Machines in the Overall Visual Field)</title>
          <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.</description>
          <population>The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their visual field (overall).</population>
          <units>decibels</units>
          <param>Mean</param>
          <dispersion>1% Confidence Interval</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)</title>
        <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.</description>
        <time_frame>three hours</time_frame>
        <population>The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their inferior nasal visual field).</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Controls</title>
            <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
          <group group_id="O2">
            <title>Glaucoma Group</title>
            <description>Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)</title>
          <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.</description>
          <population>The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their inferior nasal visual field).</population>
          <units>decibels</units>
          <param>Mean</param>
          <dispersion>1% Confidence Interval</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field</title>
        <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.</description>
        <time_frame>three hours</time_frame>
        <population>The mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across the superior hemifield portion of their visual field.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Controls</title>
            <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
          <group group_id="O2">
            <title>Glaucoma Group</title>
            <description>Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.</description>
          </group>
        </group_list>
        <measure>
          <title>Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field</title>
          <description>Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.</description>
          <population>The mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across the superior hemifield portion of their visual field.</population>
          <units>decibels</units>
          <param>Mean</param>
          <dispersion>1% Confidence Interval</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy Controls</title>
          <description>Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, reliable standard automatic perimetry and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.&#xD;
Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.&#xD;
visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.</description>
        </group>
        <group group_id="E2">
          <title>Glaucoma Group</title>
          <description>Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.&#xD;
Standard Automatic Perimetry Humphrey Field Analyzer: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.&#xD;
visuALL Field Analyzer: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.</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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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>Disadvantages of VisuALL are similar to standard automated perimetry. They rely on patient cooperation and concentration during visual field examination. In addition, the system does not include follow-up analysis. The head-mounted device may not be preferred by subjects with claustrophobic tendencies.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>M. Reza Razeghinejad, MD</name_or_title>
      <organization>Wills Eye Hospital</organization>
      <phone>12159283197</phone>
      <email>reza@willseye.org</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/NCT03804684
org study id: IRB Control #18-768E
nct id: NCT03804684
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal
      sensitivity and to assess the repeatability of the measured values and compare them with
      those measured by a Standard Automatic Perimetry (SAP).
Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central
      and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases
      such as glaucoma. The current device has its own limitation such as positioning for the
      duration of the test which makes is hard for older patients especially those with back or
      other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the
      patients refractive errors, etc.

      Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the
      Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient
      comfort.

      The main goal of this study is to evaluate the repeatability of a novel psychophysical
      platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities.
      Other objectives of this study include the development of an initial reference database and
      comparison of the measured parameters with HFA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean Retinal Sensitivity From Two Machines
time frame: three hours
description: Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.
measure: Global Correlation (Agreement Between Two Machines in the Overall Visual Field)
time frame: three hours
description: Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.
measure: Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)
time frame: three hours
description: Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.
measure: Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field
time frame: three hours
description: Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.
arm group label: Healthy Controls
arm group type: Experimental
description: Healthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
arm group label: Mild and Moderate Glaucoma
arm group type: Experimental
description: Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.
intervention type: Diagnostic Test
intervention name: Standard Automatic Perimetry Humphrey Field Analyzer
description: Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.
arm group label: Healthy Controls
arm group label: Mild and Moderate Glaucoma
other name: SAP HFA
intervention type: Diagnostic Test
intervention name: visuALL Field Analyzer
description: visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.
arm group label: Healthy Controls
arm group label: Mild and Moderate Glaucoma
other name: vFA
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: M Reza Razeghinejad, MD
role: Principal Investigator
affiliation: Wills Eye
facility: 
country: United States
citation: Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.
PMID: 32941320
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: M. Reza Razeghinejad MD
investigator title: Principal Investigator
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Disadvantages of VisuALL are similar to standard automated perimetry. They rely on patient cooperation and concentration during visual field examination. In addition, the system does not include follow-up analysis. The head-mounted device may not be preferred by subjects with claustrophobic tendencies.
point of contact: 