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Discovering markers for brain lesion localization through eye movement examination

Status Approved

  • First Submitted Date

    2020/12/03

  • Registered Date

    2020/12/31

  • Last Updated Date

    2020/12/23

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005725
    Unique Protocol ID 2020AN0344
    Public/Brief Title Discovering markers for brain lesion localization through eye movement examination
    Scientific Title Discovering markers for brain lesion localization through eye movement examination
    Acronym DMBLL
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020AN0344
    Approval Date 2020-07-24
    Institutional Review Board Name Institutional Ethics Review Committee of Korea University College of Medicine and Anam Hospital
    Institutional Review Board Address 73, Inchon-ro, Seongbuk-gu, Seoul
    Institutional Review Board Telephone 02-920-6566
    Data Monitoring Committee Yes
    Institutional Ethics Review Committee of Korea University College of Medicine and Anam Hospital
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sunuk Lee
    Title Chief of research
    Telephone +82-2-920-5510
    Affiliation Korea University Anam Hospital
    Address 73 Korea-daero, Seongbuk-gu, Seoul
    Contact Person for Public Queries
    Name Jungeun Huh
    Title CRC
    Telephone +82-2-920-6020
    Affiliation Korea University Anam Hospital
    Address 73 Korea-daero, Seongbuk-gu, Seoul
    Contact Person for Updating Information
    Name Jungeun Huh
    Title CRC
    Telephone +82-2-920-6020
    Affiliation Korea University Anam Hospital
    Address 73 Korea-daero, Seongbuk-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-08-20 Actual
    Target Number of Participant 150
    Primary Completion Date
    Study Completion Date 2021-07-26 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Korea University Anam Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-08-20 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Others
    Project ID HI14C3477
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea University Anam Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1) Limitations of existing test equipment for neuro-ophthalmic diagnosis
    -Visual field disorder evaluation using Humphrey perimetry and Goldman perimetry, which are currently used in clinical practice, is a method of instructing the patient to look at the center while the head is fixed. Therefore, the test is limited or impossible in patients with brain lesions where cognitive function is deteriorated or it is difficult to maintain a fixed posture because patient cooperation is absolutely required.
    -The tests that are currently used in clinical practice (9 gaze photo, Lancaster test, video nystagmus test) to determine the cause of strabismus and to evaluate extraocular muscle palsy are highly dependent on the evaluator as they rely on expert judgment to determine the presence or absence of abnormalities.
    -In order to evaluate visual field disorders and ocular movement disorders, more than six ophthalmic examinations and examinations must be combined, so there are limitations in that it takes a lot of cost and test time.
    2) Clinical use of 3D virtual reality-based eye tracking device (Virtual Reality Headset; FOVE-HMD, FOVE, Inc)
    -An eye tracking device using 3D virtual reality (VR) has been developed and is widely used in games, education, and healthcare fields.
    -In order to overcome the limitations of existing clinical examination equipment, using a 3D virtual reality-based eye tracking device can acquire various biomarkers such as speed, angle, and distance of eye movement related to eye movement.
    -If the correlation and agreement with the biomarkers obtained through the currently used clinical test methods are high, it is expected that the eye tracking device can be used clinically to overcome the limitations of the existing test methods.
    -Prior to evaluating the clinical application value and effectiveness of the eye tracking device, it is first necessary to discover clinical indicators that can be applied to diagnosis and severity assessment based on the biomarkers obtained through the eye tracking device.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 150
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Normal control group, patient group

    Cohort/Group Description

    -Normal control group: 100 healthy adults over 20 years of age without a history of visual acuity abnormality (VA <20/200), visual field disorder, diplopia, and brain lesion disorder.
    -Patient group: Among patients who visited Korea University Anam Hospital with complaining of symptoms such as diplopia and vertigo, eye movement disorders and visual field disorders were identified through clinical neuro-ophthalmology examination, and the causative lesion was found in the visual afferent and distal paths. 50 confirmed patients.
    
    
    The eye movements and visual acuity and fields are evaluated using a VR-based HMD. The patients are instructed to gaze a stationary or moving target, or press a button following a task thoughout the session.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Among patients who visited Korea University Anam Hospital with complaining of symptoms such as diplopia and vertigo, eye movement disorders and visual field disorders were confirmed through clinical neuro-ophthalmology examination, and the causative lesion was confirmed in the visual afferent and distal paths. 50 people.
    Sampling Method
    Among neurology patients complaining of symptoms such as diplopia and vertigo, among patients who visited Korea University Anam Hospital, eye movement disorders and visual field disorders were confirmed through clinical neuro-ophthalmology examination, and the causative lesions were visual centripetal and distal. Extracted patients identified in the furnace.
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H44.9)Disorder of globe, unspecified 

    H00–H59 Patients with eye movement disorders and visual field disorders identified through clinical neuro-ophthalmology examination, and the causative lesions in the visual afferent and distal paths.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    -Normal control group: 100 healthy adults over 20 years of age without a history of visual acuity abnormality (VA <20/200), visual field disorder, diplopia, and brain lesion disorder.
    -Patient group: Among patients who visited Korea University Anam Hospital with complaining of symptoms such as diplopia and vertigo, eye movement disorders and visual field disorders were identified through clinical neuro-ophthalmology examination, and the causative lesion was found in the visual afferent and distal paths. 50 confirmed patients.
    Exclusion Criteria
    Patients who complain of ocular movement disorder or visual field disorder, but the etiology or lesion is not specified through neuro-ophthalmology examination.
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    near point of convergence, ocular torsion, ocular misalignment (prism diopter), saccadic velocity, gain, smooth pursuit gain, visual field (mean deviation, pattern standard deviation)
    Timepoint
    Before participating in the study
    Secondary Outcome(s) 1
    Outcome
    none
    Timepoint
    Before participating in the study
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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