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Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma (OXSIGHT)

Primary Purpose

Advanced Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OXSIGHT smart glasses
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Glaucoma focused on measuring OXSIGHT, advanced glaucoma, low vision aids, head-mounted electronic devices

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age ≥10 years, able to complete all tests and inspections;
  2. a definite diagnosis of primary or secondary glaucoma or glaucoma in children;
  3. the best corrected visual acuity of the better eye is no more than 0.3 and better than 0.05; visual field ≤10° and MD value < -12db;
  4. Visual acuity, intraocular pressure, and other eye conditions have been stable for more than 6 months.

Exclusion Criteria:

  1. unable to cooperate with related inspections;
  2. a history of eye surgery or eye laser within 6 months;
  3. diseases that interfere with the diagnosis of glaucoma, such as optic disc dysplasia, obvious anisometropia, retinal vascular diseases, optic nerve diseases, macular degeneration, cerebrovascular diseases, etc.;
  4. pregnant or lactating women;
  5. those who refuse to sign the informed consent or voluntarily withdraw from the study due to discomfort or other reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    OXSIGHT smart glasses

    Arm Description

    Wearing OXSIGHT smart glasses

    Outcomes

    Primary Outcome Measures

    Changes from baseline CLVQOL scores at different time points
    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.

    Secondary Outcome Measures

    Changes from baseline visual acuity at different time points
    ETDRS visual acuity chart was used.
    Changes from baseline contrast sensitivity at different time points
    Pelli-Robson Contrast Sensitivity Charts were used.
    Changes from baseline visual field at different time points
    Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.
    Changes from baseline scores of mobility test at different time points
    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.

    Full Information

    First Posted
    June 10, 2020
    Last Updated
    June 15, 2020
    Sponsor
    Zhongshan Ophthalmic Center, Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04434612
    Brief Title
    Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
    Acronym
    OXSIGHT
    Official Title
    Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 6, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zhongshan Ophthalmic Center, Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. 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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Glaucoma
    Keywords
    OXSIGHT, advanced glaucoma, low vision aids, head-mounted electronic devices

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OXSIGHT smart glasses
    Arm Type
    Experimental
    Arm Description
    Wearing OXSIGHT smart glasses
    Intervention Type
    Device
    Intervention Name(s)
    OXSIGHT smart glasses
    Other Intervention Name(s)
    There is no
    Intervention Description
    OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.
    Primary Outcome Measure Information:
    Title
    Changes from baseline CLVQOL scores at different time points
    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.
    Time Frame
    The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
    Secondary Outcome Measure Information:
    Title
    Changes from baseline visual acuity at different time points
    Description
    ETDRS visual acuity chart was used.
    Time Frame
    The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
    Title
    Changes from baseline contrast sensitivity at different time points
    Description
    Pelli-Robson Contrast Sensitivity Charts were used.
    Time Frame
    The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
    Title
    Changes from baseline visual field at different time points
    Description
    Visual field was measured by the kinetic perimetry test of Humphrey field analyzer.
    Time Frame
    The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.
    Title
    Changes from baseline scores of mobility test at different time points
    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.
    Time Frame
    The examination was performed at 1 day, 1 week, 2 weeks, 4 weeks and 8 weeks after intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥10 years, able to complete all tests and inspections; a definite diagnosis of primary or secondary glaucoma or glaucoma in children; the best corrected visual acuity of the better eye is no more than 0.3 and better than 0.05; visual field ≤10° and MD value < -12db; Visual acuity, intraocular pressure, and other eye conditions have been stable for more than 6 months. Exclusion Criteria: unable to cooperate with related inspections; a history of eye surgery or eye laser within 6 months; diseases that interfere with the diagnosis of glaucoma, such as optic disc dysplasia, obvious anisometropia, retinal vascular diseases, optic nerve diseases, macular degeneration, cerebrovascular diseases, etc.; pregnant or lactating women; those who refuse to sign the informed consent or voluntarily withdraw from the study due to discomfort or other reasons.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yiqing Li, doctor
    Phone
    13302235127
    Email
    liyiqing@gzzoc.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhidong Li, doctor
    Phone
    15521059530
    Email
    aiyou1989@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11673287
    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.
    Results Reference
    background
    PubMed Identifier
    16488940
    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.
    Results Reference
    result
    Links:
    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?

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    Effect of OXSIGHT Smart Glasses on Patients With Advanced Glaucoma

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