<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/NCT03234504</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0507</org_study_id>
    <nct_id>NCT03234504</nct_id>
  </id_info>
  <brief_title>Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display</brief_title>
  <official_title>Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      This prospective study investigated the validity and test-retest reliability of stereopsis&#xD;
      test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195&#xD;
      arc of seconds(arc secs)) were generated as separate images on a high resolution phone&#xD;
      display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon,&#xD;
      Korea). Two images were independently projected to each eye as graded circles with random dot&#xD;
      background. While the position of the stimulus changed from among 3 possible locations, the&#xD;
      subjects were instructed to select the circle with disparity by pressing the corresponding&#xD;
      position on a keypad. The results of the new HMD stereotest were compared to those from&#xD;
      standard Randot and TNO stereotests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between stereopsis with head mount display and stereopsis with Randot or TNO test</measure>
    <time_frame>one visit</time_frame>
    <description>Stereopsis results was expressed as arc sec. The association between log arc sec in stereopsis with HMD display and Randot or TNO test were evaluated. Using Bland Altman plot, the mean differences between two stereopsis results were compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test-retest variability of stereopsis using head mount display</measure>
    <time_frame>one visit</time_frame>
    <description>The intraclass coefficient was calculated between initial head mount display stereopsis result and retests.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Normal Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Normal healthy volunteers</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        normal healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. The subjects who want or need to visual acuity test or to test for a prescription for&#xD;
        glasses visited the hospital. 2. The Subjects' ages ranged from 19 to 60 years in the&#xD;
        study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ocular alignment was assessed with cover-uncover and alternate prism cover testing at&#xD;
             distance and near. Significant exodeviation included exophoria was considered to be ≥6&#xD;
             prism diopters were excluded.&#xD;
&#xD;
          2. Subjects with a history of ocular surgery within 3 months of the study were excluded.&#xD;
&#xD;
          3. Foreigners or subjects who are unable to understand informed consent were excluded.&#xD;
&#xD;
          4. Subjects with a history of eye problems, including infection, inflammation, cataract,&#xD;
             vitreous opacity or retinal diseases were excluded.&#xD;
&#xD;
          5. Subjects with corrected visual acuity of 20/32 in bad eye were excluded.&#xD;
&#xD;
          6. Subjects with significant refractive error considered to be ≥2.00 diopters of&#xD;
             anisometropia were excluded.&#xD;
&#xD;
          7. A female who is pregnant, may be pregnant, or is lactating was excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jinu Han, MD</last_name>
    <phone>+82-10-3764-7746</phone>
    <email>jinuhan@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Vision Research, Department of Ophthalmology</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinu Han, MD</last_name>
      <phone>+82-10-3764-7746</phone>
      <email>jinuhan@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>June 19, 2018</last_update_submitted>
  <last_update_submitted_qc>June 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03234504
org study id: 4-2017-0507
nct id: NCT03234504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective study investigated the validity and test-retest reliability of stereopsis
      test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195
      arc of seconds(arc secs)) were generated as separate images on a high resolution phone
      display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon,
      Korea). Two images were independently projected to each eye as graded circles with random dot
      background. While the position of the stimulus changed from among 3 possible locations, the
      subjects were instructed to select the circle with disparity by pressing the corresponding
      position on a keypad. The results of the new HMD stereotest were compared to those from
      standard Randot and TNO stereotests.
observational model: Other
time perspective: Prospective
measure: Correlation between stereopsis with head mount display and stereopsis with Randot or TNO test
time frame: one visit
description: Stereopsis results was expressed as arc sec. The association between log arc sec in stereopsis with HMD display and Randot or TNO test were evaluated. Using Bland Altman plot, the mean differences between two stereopsis results were compared.
measure: Test-retest variability of stereopsis using head mount display
time frame: one visit
description: The intraclass coefficient was calculated between initial head mount display stereopsis result and retests.
arm group label: Normal healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jinu Han, MD
phone: +82-10-3764-7746
email: jinuhan@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No