<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/NCT03248388</url>
  </required_header>
  <id_info>
    <org_study_id>17-003289</org_study_id>
    <nct_id>NCT03248388</nct_id>
  </id_info>
  <brief_title>Argus II/ORCAM Device Study</brief_title>
  <official_title>Utility of Visual Pattern Recognition Technology in Retinal Prosthesis Patients: the ARGUSII/ORCAM Device Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Sight Medical Products</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to determine if wearable text-to-speech (TTS) and visual pattern&#xD;
      recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow&#xD;
      patients to read and recognize faces and objects.&#xD;
&#xD;
      The Argus II retinal prosthesis can restore rudimentary forms of vision to patients with bare&#xD;
      light-perception vision. Using the prosthesis, patients can identify obstacles, handles,&#xD;
      switches, eating utensils and demonstrate improved navigation when used in conjunction with&#xD;
      other ambulation-assist tools. Current limits in the resolution of the device prevent useful&#xD;
      reading or face recognition. The FDA has approved the Argus II as a humanitarian device.&#xD;
&#xD;
      Present-day wearable text-to-speech converters are also capable of object and face&#xD;
      recognition. Such systems have been developed to assist with these tasks in patients with&#xD;
      severe low-vision. ORCAM is a commercially-available eyeglass-mounted visual pattern&#xD;
      recognition system capable of converting photographs of text to speech. It is comprised of a&#xD;
      camera, a small belt-worn computer, pattern recognition software and a small audio&#xD;
      transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user&#xD;
      through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize&#xD;
      faces and speak the name of the individual to the user. ORCAM can also be used to recognize&#xD;
      everyday products after being programmed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Orcam device will be mounted onto the Argus II eyeglasses. The subject will be asked to&#xD;
      use the Orcam device with and without the Argus II. After a half-day interactive training&#xD;
      session with the Orcam device, the investigators will interview the subject with a&#xD;
      questionnaire. The investigators will then contact the subject every two weeks via a&#xD;
      telephone call for two months (4 phone interviews). The investigators will then ask the&#xD;
      subject to return to Mayo Clinic to demonstrate their ability to use the Argus II and Orcam&#xD;
      together and separately. These sessions will be videotaped.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Who Are Able to Use the ORCAM device With the Argus II Device at the End of the Study</measure>
    <time_frame>End of study, approximately 4 months</time_frame>
    <description>Subjects will be familiar with using their retinal prosthesis, the Argus II Device. At baseline, the ORCAM device will be mounted on the Argus II eyeglasses.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Retinitis Pigmentosa</condition>
  <arm_group>
    <arm_group_label>Adults with Retinitis Pigmentosa using ARGUS II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will use the ORCAM system mounted onto the Argus II eyeglasses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Argus II Eyeglasses</intervention_name>
    <description>The Argus II Eyeglasses (retinal prosthesis) can restore rudimentary forms of vision to patients with bare light-perception vision. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. Current limits in the resolution of the device prevent useful reading or face recognition.</description>
    <arm_group_label>Adults with Retinitis Pigmentosa using ARGUS II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ORCAM</intervention_name>
    <description>ORCAM is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. It is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize faces and speak the name of the individual to the user. ORCAM can also be used to recognize everyday products after being programmed.</description>
    <arm_group_label>Adults with Retinitis Pigmentosa using ARGUS II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of advanced retinitis pigmentosa&#xD;
&#xD;
          -  Subjects must have an Argus II device implanted to be eligible for this study&#xD;
&#xD;
          -  Subjects must be familiar with using their Argus II device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - No Argus II implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond Iezzi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Raymond Iezzi</investigator_full_name>
    <investigator_title>Associate Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinitis</mesh_term>
    <mesh_term>Retinitis Pigmentosa</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248388
org study id: 17-003289
nct id: NCT03248388
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This study is being done to determine if wearable text-to-speech (TTS) and visual pattern
      recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow
      patients to read and recognize faces and objects.

      The Argus II retinal prosthesis can restore rudimentary forms of vision to patients with bare
      light-perception vision. Using the prosthesis, patients can identify obstacles, handles,
      switches, eating utensils and demonstrate improved navigation when used in conjunction with
      other ambulation-assist tools. Current limits in the resolution of the device prevent useful
      reading or face recognition. The FDA has approved the Argus II as a humanitarian device.

      Present-day wearable text-to-speech converters are also capable of object and face
      recognition. Such systems have been developed to assist with these tasks in patients with
      severe low-vision. ORCAM is a commercially-available eyeglass-mounted visual pattern
      recognition system capable of converting photographs of text to speech. It is comprised of a
      camera, a small belt-worn computer, pattern recognition software and a small audio
      transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user
      through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize
      faces and speak the name of the individual to the user. ORCAM can also be used to recognize
      everyday products after being programmed.
The Orcam device will be mounted onto the Argus II eyeglasses. The subject will be asked to
      use the Orcam device with and without the Argus II. After a half-day interactive training
      session with the Orcam device, the investigators will interview the subject with a
      questionnaire. The investigators will then contact the subject every two weeks via a
      telephone call for two months (4 phone interviews). The investigators will then ask the
      subject to return to Mayo Clinic to demonstrate their ability to use the Argus II and Orcam
      together and separately. These sessions will be videotaped.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Number of Subjects Who Are Able to Use the ORCAM device With the Argus II Device at the End of the Study
time frame: End of study, approximately 4 months
description: Subjects will be familiar with using their retinal prosthesis, the Argus II Device. At baseline, the ORCAM device will be mounted on the Argus II eyeglasses.
arm group label: Adults with Retinitis Pigmentosa using ARGUS II
arm group type: Experimental
description: Subjects will use the ORCAM system mounted onto the Argus II eyeglasses.
intervention type: Device
intervention name: Argus II Eyeglasses
description: The Argus II Eyeglasses (retinal prosthesis) can restore rudimentary forms of vision to patients with bare light-perception vision. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. Current limits in the resolution of the device prevent useful reading or face recognition.
arm group label: Adults with Retinitis Pigmentosa using ARGUS II
intervention type: Device
intervention name: ORCAM
description: ORCAM is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. It is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize faces and speak the name of the individual to the user. ORCAM can also be used to recognize everyday products after being programmed.
arm group label: Adults with Retinitis Pigmentosa using ARGUS II
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raymond Iezzi
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Raymond Iezzi
investigator title: Associate Professor of Ophthalmology
mesh term: Retinitis
mesh term: Retinitis Pigmentosa