<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/NCT04421859</url>
  </required_header>
  <id_info>
    <org_study_id>11141902</org_study_id>
    <nct_id>NCT04421859</nct_id>
  </id_info>
  <brief_title>Augmented Reality Mobile Application for Glaucoma Education in the South Bronx</brief_title>
  <official_title>Augmented Reality Mobile Application for Glaucoma Education in the South Bronx</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bronx-Lebanon Hospital Center Health Care System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EyeCU Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VISRE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bronx-Lebanon Hospital Center Health Care System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A team at the National Healthcare Group Eye Institute in Singapore have developed an&#xD;
      augmented reality mobile phone application, EyeCU, to simulate glaucoma progression and&#xD;
      enhance understanding about the disease and its course. It is a bilingual (English/Spanish)&#xD;
      application that is free-to-download on the Android and Apple app store. As eye care&#xD;
      physicians in the South Bronx, the investigators are hopeful that the findings in this study&#xD;
      can be extrapolated to our patients in the South Bronx, where poor health literacy,&#xD;
      non-adherence to glaucoma medication and poor follow-up remains a large barrier. The&#xD;
      investigators hope that by offering the simulation in both English and Spanish, the&#xD;
      investigators will not only be able to improve our patients' understanding of glaucoma, but&#xD;
      also improve glaucoma treatment adherence and assess our patient population's responsiveness&#xD;
      to augmented reality as an educational platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental design: Pilot cohort study&#xD;
&#xD;
      Data collection: Patient characteristics such as age, sex, ethnicity, preferred language, zip&#xD;
      code, employment status, highest educational attainment, current topical eye medications,&#xD;
      Past Ocular History, Past Medical History&#xD;
&#xD;
      Recruitment for participation in the study will be performed during glaucoma clinic&#xD;
      registration Consent will be conducted by a member of the research team who is not directly&#xD;
      involved in the participant's clinical care Pre-intervention glaucoma knowledge questionnaire&#xD;
      (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on&#xD;
      dedicated clinic tablet device.&#xD;
&#xD;
      Post-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire)&#xD;
      will be given to participants, to be completed on dedicated clinic tablet device.&#xD;
&#xD;
      Rate of missed glaucoma follow-up appointments before and 6 months after application use will&#xD;
      be collected from the electronic medical record.&#xD;
&#xD;
      Rate of medication adherence before and 6 months after application use will be collected from&#xD;
      the electronic medical record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Questionnaire Scores</measure>
    <time_frame>From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months</time_frame>
    <description>Scores of pre- and post-intervention NEHEP glaucoma knowledge questionnaires will be compared</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Follow Up Adherence</measure>
    <time_frame>Before and 6 months after intervention</time_frame>
    <description>Attendance rate at glaucoma follow-ups will be collected from electronic medical record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Medication Adherence</measure>
    <time_frame>Before and 6 months after intervention</time_frame>
    <description>Self-reported adherence to glaucoma medications will be collected from electronic medical record</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>EyeCU App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Augmented reality mobile application called &quot;EyeCU&quot; which simulates glaucoma progression and enhances understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. It will be delivered on a hospital owned tablet device and patients will be instructed to complete two sections, taking approximately 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EyeCU Mobile Application</intervention_name>
    <description>Augmented reality glaucoma education mobile phone application</description>
    <arm_group_label>EyeCU App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with a clinical diagnosis of glaucoma on medical therapy for at least 4 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with optic neuropathies unrelated to glaucoma&#xD;
&#xD;
          -  Patients with VA 20/100 or worse in both eyes&#xD;
&#xD;
          -  Visual defects involving fixation in both eyes&#xD;
&#xD;
          -  Patients with symptoms impairing ability to operate a smartphone during visit&#xD;
             including diplopia, motor difficulties, cognitive impairment, illiteracy&#xD;
&#xD;
          -  Patients who are unable to read or understand English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BronxCare Health System</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bronx-Lebanon Hospital Center Health Care System</investigator_affiliation>
    <investigator_full_name>Dr. Stephen Lau</investigator_full_name>
    <investigator_title>Ophthalmology Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04421859
org study id: 11141902
nct id: NCT04421859
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A team at the National Healthcare Group Eye Institute in Singapore have developed an
      augmented reality mobile phone application, EyeCU, to simulate glaucoma progression and
      enhance understanding about the disease and its course. It is a bilingual (English/Spanish)
      application that is free-to-download on the Android and Apple app store. As eye care
      physicians in the South Bronx, the investigators are hopeful that the findings in this study
      can be extrapolated to our patients in the South Bronx, where poor health literacy,
      non-adherence to glaucoma medication and poor follow-up remains a large barrier. The
      investigators hope that by offering the simulation in both English and Spanish, the
      investigators will not only be able to improve our patients' understanding of glaucoma, but
      also improve glaucoma treatment adherence and assess our patient population's responsiveness
      to augmented reality as an educational platform.
Experimental design: Pilot cohort study

      Data collection: Patient characteristics such as age, sex, ethnicity, preferred language, zip
      code, employment status, highest educational attainment, current topical eye medications,
      Past Ocular History, Past Medical History

      Recruitment for participation in the study will be performed during glaucoma clinic
      registration Consent will be conducted by a member of the research team who is not directly
      involved in the participant's clinical care Pre-intervention glaucoma knowledge questionnaire
      (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on
      dedicated clinic tablet device.

      Post-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire)
      will be given to participants, to be completed on dedicated clinic tablet device.

      Rate of missed glaucoma follow-up appointments before and 6 months after application use will
      be collected from the electronic medical record.

      Rate of medication adherence before and 6 months after application use will be collected from
      the electronic medical record.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Questionnaire Scores
time frame: From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months
description: Scores of pre- and post-intervention NEHEP glaucoma knowledge questionnaires will be compared
measure: Change in Follow Up Adherence
time frame: Before and 6 months after intervention
description: Attendance rate at glaucoma follow-ups will be collected from electronic medical record
measure: Change in Medication Adherence
time frame: Before and 6 months after intervention
description: Self-reported adherence to glaucoma medications will be collected from electronic medical record
arm group label: EyeCU App
arm group type: Experimental
description: Augmented reality mobile application called "EyeCU" which simulates glaucoma progression and enhances understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. It will be delivered on a hospital owned tablet device and patients will be instructed to complete two sections, taking approximately 10 minutes.
intervention type: Other
intervention name: EyeCU Mobile Application
description: Augmented reality glaucoma education mobile phone application
arm group label: EyeCU App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Bronx-Lebanon Hospital Center Health Care System
investigator full name: Dr. Stephen Lau
investigator title: Ophthalmology Resident
mesh term: Glaucoma
sharing ipd: No