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
CRIS Registration Number |
KCT0005725 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Others |
Project ID | HI14C3477 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea University Anam Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
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. |
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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)
Type of Primary Outcome | Efficacy | |
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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) |
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Timepoint | Before participating in the study |
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Secondary Outcome(s) 1 | ||
Outcome | none |
|
Timepoint | Before participating in the study |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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