<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/NCT04434612</url>
  </required_header>
  <id_info>
    <org_study_id>zhongshanOCOXSIGHT</org_study_id>
    <nct_id>NCT04434612</nct_id>
  </id_info>
  <brief_title>Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma</brief_title>
  <acronym>OXSIGHT</acronym>
  <official_title>Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Glaucoma is the leading cause of irreversible blindness worldwide. The visual function of&#xD;
      patients with advanced glaucoma is severely impaired, and the vision-related activities (e.g.&#xD;
      movement, reading) are obviously restricted, which may have a negative impact on the&#xD;
      patients' quality of life (QOL) and increase the burden on individuals and families. Low&#xD;
      vision aids (LVAs) and other devices for vision rehabilitation (VR) are useful for patients&#xD;
      with advanced glaucoma to maximize the function of residual vision and improve the QOL.&#xD;
      OXSIGHT smart glasses are the latest LVAs eyeglasses that are expected to improve the QOL for&#xD;
      patients with low vision (LV), such as those with glaucoma. Clinical data were collected to&#xD;
      evaluate the efficacy and its influencing factors of OXSIGHT smart glasses in patients with&#xD;
      advanced glaucoma, in providing theoretical basis for subsequent clinical studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Glaucomatous low vision. Glaucoma is a chronic eye disease that causes irreversible&#xD;
           damage to the optic nerve and can lead to severe vision loss and blindness. Low vision&#xD;
           (LV) is a decrease in vision that cannot be corrected with standard glasses, contact&#xD;
           lenses, medication or surgery, impairing a person's ability to perform age-appropriate&#xD;
           vision-dependent tasks.&#xD;
&#xD;
        2. Low vision rehabilitation. Low Vision Rehabilitation (LVR) is part of the continuum of&#xD;
           eye care that extends from diagnosis to treatment and rehabilitation, designed to help&#xD;
           visually impaired patients retain vision to the maximum, make activities easier to&#xD;
           perform, regain independence, and improve their QOL. LVR services include comprehensive&#xD;
           assessment of visual function, prescription of LVAs, rehabilitation training and&#xD;
           referrals to a range of community services and psychosocial support.&#xD;
&#xD;
        3. Research status of intelligent head-mounted devices. In recent years, video head-mounted&#xD;
           devices have been gradually applied in the field of VR, with the advantages of high&#xD;
           definition, diverse processing modes, adjustable magnification, contrast and brightness,&#xD;
           which overcome the limitations of traditional devices, like eSight 3, NuEyes, and&#xD;
           IrisVision. However, studies on the effectiveness of head-mounted electronic LVAs are&#xD;
           quite limited.&#xD;
&#xD;
        4. OXSIGHT smart glasses. OXSIGHT smart glasses, the latest generation of head-mounted&#xD;
           electronic LVAs, developed by the team of Oxford University in the UK, are designed for&#xD;
           LV patients with visual field defects. Based on the previous generation, OXSIGHT has the&#xD;
           advantages of lighter weight, comfortable wearing, better imaging quality, multi-mode&#xD;
           assisted visual recognition and so on. However, the efficacy and influencing factors of&#xD;
           OXSIGHT smart glasses on advanced glaucoma patients remain unclear, and further studies&#xD;
           are needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 6, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline CLVQOL scores at different time points</measure>
    <time_frame>The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.</time_frame>
    <description>The Low vision Quality of Life Questionnaire (LVQOL) specifically investigates the QOL of visually impaired patients. The questionnaire consists of 25 closed items and examines four dimensions: distance vision, mobility and lighting; adjustment; reading and fine work; daily activities. As a convenient tool, LVQOL is widely used in clinical settings to evaluate effects of clinical treatment and corresponding strategies of low-vision rehabilitation. CLVQOL is the Chinese version of LVQOL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline visual acuity at different time points</measure>
    <time_frame>The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.</time_frame>
    <description>ETDRS visual acuity chart was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline contrast sensitivity at different time points</measure>
    <time_frame>The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.</time_frame>
    <description>Pelli-Robson Contrast Sensitivity Charts were used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline visual field at different time points</measure>
    <time_frame>The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.</time_frame>
    <description>Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline scores of mobility test at different time points</measure>
    <time_frame>The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.</time_frame>
    <description>A mobility test was performed to evaluate patients' functionality in 2 scenarios: using their best-corrected visual acuity with no LVAs and using the OXSIGHT Smart Glasses. A loop-shaped obstacle course consisting of stationary obstacles from floor to head level was designed for this test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Advanced Glaucoma</condition>
  <arm_group>
    <arm_group_label>OXSIGHT smart glasses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wearing OXSIGHT smart glasses</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OXSIGHT smart glasses</intervention_name>
    <description>OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.</description>
    <arm_group_label>OXSIGHT smart glasses</arm_group_label>
    <other_name>There is no</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥10 years, able to complete all tests and inspections;&#xD;
&#xD;
          2. a definite diagnosis of primary or secondary glaucoma or glaucoma in children;&#xD;
&#xD;
          3. the best corrected visual acuity of the better eye is no more than 0.3 and better than&#xD;
             0.05; visual field ≤10° and MD value &lt; -12db;&#xD;
&#xD;
          4. Visual acuity, intraocular pressure, and other eye conditions have been stable for&#xD;
             more than 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. unable to cooperate with related inspections;&#xD;
&#xD;
          2. a history of eye surgery or eye laser within 6 months;&#xD;
&#xD;
          3. diseases that interfere with the diagnosis of glaucoma, such as optic disc dysplasia,&#xD;
             obvious anisometropia, retinal vascular diseases, optic nerve diseases, macular&#xD;
             degeneration, cerebrovascular diseases, etc.;&#xD;
&#xD;
          4. pregnant or lactating women;&#xD;
&#xD;
          5. those who refuse to sign the informed consent or voluntarily withdraw from the study&#xD;
             due to discomfort or other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yiqing Li, doctor</last_name>
    <phone>13302235127</phone>
    <email>liyiqing@gzzoc.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhidong Li, doctor</last_name>
    <phone>15521059530</phone>
    <email>aiyou1989@163.com</email>
  </overall_contact_backup>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/16488940/?from_term=The+number+of+people+with+glaucoma+worldwide+in+2010+and+2020%5B</url>
    <description>The Number of People With Glaucoma Worldwide in 2010 and 2020</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/11673287/?from_single_result=Johnson+G+J+.+Glaucoma+in+China%3A+how+big+is+the+problem%3F%5BJ%5D.+Br+J+Ophthalmol%2C&amp;expanded_search_query=Johnson+G+J+.+Glaucoma+in+China%3A+how+big+is+the+problem%3F%5BJ%5D.+Br+J+Ophthalmol%2C</url>
    <description>Glaucoma in China: How Big Is the Problem?</description>
  </link>
  <reference>
    <citation>Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277.</citation>
    <PMID>11673287</PMID>
  </reference>
  <results_reference>
    <citation>Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.</citation>
    <PMID>16488940</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OXSIGHT</keyword>
  <keyword>advanced glaucoma</keyword>
  <keyword>low vision aids</keyword>
  <keyword>head-mounted electronic devices</keyword>
  <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/NCT04434612
org study id: zhongshanOCOXSIGHT
nct id: NCT04434612
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Glaucoma is the leading cause of irreversible blindness worldwide. The visual function of
      patients with advanced glaucoma is severely impaired, and the vision-related activities (e.g.
      movement, reading) are obviously restricted, which may have a negative impact on the
      patients' quality of life (QOL) and increase the burden on individuals and families. Low
      vision aids (LVAs) and other devices for vision rehabilitation (VR) are useful for patients
      with advanced glaucoma to maximize the function of residual vision and improve the QOL.
      OXSIGHT smart glasses are the latest LVAs eyeglasses that are expected to improve the QOL for
      patients with low vision (LV), such as those with glaucoma. Clinical data were collected to
      evaluate the efficacy and its influencing factors of OXSIGHT smart glasses in patients with
      advanced glaucoma, in providing theoretical basis for subsequent clinical studies.
1. Glaucomatous low vision. Glaucoma is a chronic eye disease that causes irreversible
           damage to the optic nerve and can lead to severe vision loss and blindness. Low vision
           (LV) is a decrease in vision that cannot be corrected with standard glasses, contact
           lenses, medication or surgery, impairing a person's ability to perform age-appropriate
           vision-dependent tasks.

        2. Low vision rehabilitation. Low Vision Rehabilitation (LVR) is part of the continuum of
           eye care that extends from diagnosis to treatment and rehabilitation, designed to help
           visually impaired patients retain vision to the maximum, make activities easier to
           perform, regain independence, and improve their QOL. LVR services include comprehensive
           assessment of visual function, prescription of LVAs, rehabilitation training and
           referrals to a range of community services and psychosocial support.

        3. Research status of intelligent head-mounted devices. In recent years, video head-mounted
           devices have been gradually applied in the field of VR, with the advantages of high
           definition, diverse processing modes, adjustable magnification, contrast and brightness,
           which overcome the limitations of traditional devices, like eSight 3, NuEyes, and
           IrisVision. However, studies on the effectiveness of head-mounted electronic LVAs are
           quite limited.

        4. OXSIGHT smart glasses. OXSIGHT smart glasses, the latest generation of head-mounted
           electronic LVAs, developed by the team of Oxford University in the UK, are designed for
           LV patients with visual field defects. Based on the previous generation, OXSIGHT has the
           advantages of lighter weight, comfortable wearing, better imaging quality, multi-mode
           assisted visual recognition and so on. However, the efficacy and influencing factors of
           OXSIGHT smart glasses on advanced glaucoma patients remain unclear, and further studies
           are needed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes from baseline CLVQOL scores at different time points
time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
description: The Low vision Quality of Life Questionnaire (LVQOL) specifically investigates the QOL of visually impaired patients. The questionnaire consists of 25 closed items and examines four dimensions: distance vision, mobility and lighting; adjustment; reading and fine work; daily activities. As a convenient tool, LVQOL is widely used in clinical settings to evaluate effects of clinical treatment and corresponding strategies of low-vision rehabilitation. CLVQOL is the Chinese version of LVQOL.
measure: Changes from baseline visual acuity at different time points
time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
description: ETDRS visual acuity chart was used.
measure: Changes from baseline contrast sensitivity at different time points
time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
description: Pelli-Robson Contrast Sensitivity Charts were used.
measure: Changes from baseline visual field at different time points
time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
description: Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.
measure: Changes from baseline scores of mobility test at different time points
time frame: The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
description: A mobility test was performed to evaluate patients' functionality in 2 scenarios: using their best-corrected visual acuity with no LVAs and using the OXSIGHT Smart Glasses. A loop-shaped obstacle course consisting of stationary obstacles from floor to head level was designed for this test.
arm group label: OXSIGHT smart glasses
arm group type: Experimental
description: Wearing OXSIGHT smart glasses
intervention type: Device
intervention name: OXSIGHT smart glasses
description: OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.
arm group label: OXSIGHT smart glasses
other name: There is no
criteria: 
gender: All
minimum age: 10 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yiqing Li, doctor
phone: 13302235127
email: liyiqing@gzzoc.com
last name: Zhidong Li, doctor
phone: 15521059530
email: aiyou1989@163.com
url: https://pubmed.ncbi.nlm.nih.gov/16488940/?from_term=The+number+of+people+with+glaucoma+worldwide+in+2010+and+2020%5B
description: The Number of People With Glaucoma Worldwide in 2010 and 2020
url: https://pubmed.ncbi.nlm.nih.gov/11673287/?from_single_result=Johnson+G+J+.+Glaucoma+in+China%3A+how+big+is+the+problem%3F%5BJ%5D.+Br+J+Ophthalmol%2C&expanded_search_query=Johnson+G+J+.+Glaucoma+in+China%3A+how+big+is+the+problem%3F%5BJ%5D.+Br+J+Ophthalmol%2C
description: Glaucoma in China: How Big Is the Problem?
citation: Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277.
PMID: 11673287
citation: Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PMID: 16488940
responsible party type: Sponsor
mesh term: Glaucoma
sharing ipd: No