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Evaluation of safety and effectiveness of a multimodal imaging device HWSO-1 through comparison of various retinal images: Huvitz HWSO-1 vs Heidelberg Spectralis and Topcon Maestro II (Prospective, single-center, open-label, single-group, post-marketing clinical trial)

Status Approved

  • First Submitted Date

    2023/12/04

  • Registered Date

    2024/01/09

  • Last Updated Date

    2023/12/20

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
    KCT0009101
    Unique Protocol ID 2 0 2 2 A N 0 5 4 6
    Public/Brief Title Evaluation of safety and effectiveness of a multimodal imaging device HWSO-1 through comparison of various retinal images
    Scientific Title Evaluation of safety and effectiveness of a multimodal imaging device HWSO-1 through comparison of various retinal images: Huvitz HWSO-1 vs Heidelberg Spectralis and Topcon Maestro II (Prospective, single-center, open-label, single-group, post-marketing clinical trial)
    Acronym
    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 2022AN0546
    Approval Date 2022-12-01
    Institutional Review Board Name Korea University Anam Hospital Institution Review Board
    Institutional Review Board Address 73, Inchon-ro, Seongbuk-gu, Seoul
    Institutional Review Board Telephone 02-920-6566
    Data Monitoring Committee No
  • 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 Jaeryung Oh
    Title professor
    Telephone +82-2-920-5399
    Affiliation Korea University Anam Hospital
    Address 73 Goryeodae-ro Seounggbuk-gu, seoul 02841, korea
    Contact Person for Public Queries
    Name Young Ho Kim
    Title Clinical associate professor
    Telephone +82-2-920-5520
    Affiliation Korea University Anam Hospital
    Address 73 Goryeodae-ro Seounggbuk-gu, seoul 02841, korea
    Contact Person for Updating Information
    Name Chang Soo Lee
    Title Team Leader
    Telephone +82-31-428-9151
    Affiliation Huvitz
    Address 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si
  • 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 Not yet recruiting
    Date of First Enrollment 2024-01-02 Anticipated
    Target Number of Participant 56
    Primary Completion Date 2024-10-31 , Anticipated
    Study Completion Date 2024-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Korea University Anam Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2024-01-02 ,
  • 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 Korea Medical Device Development Fund
    Organization Type Others
    Project ID RS2020KD000026
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Huvitz
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study is to evaluate the clinical safety·efficacy of the Huvitz Fundus Camera HWSO-1 by comparing fundus color images, fundus autofluorescence images, optical coherence tomography images, and optical coherence angiography images with other devices(Heidelberg Spectralis HRA2, Topcon 3D OCT) in  ocular disease and healthy eyes.
    Ophthalmic diseases are not amenable to biopsy due to the characteristics of the eye, so imaging tests play an important role in the diagnosis, treatment, follow-up, and research of many diseases, and recently, devices that analyze multiple types of images simultaneously are preferred. 
    Among the various imaging tests in ophthalmology, fundus photography, fundus autofluorescence imaging, optical coherence tomography, optical coherence angiography, fluorescein angiography, and indocyanine angiography are commonly used in daily practice. Fundus photography is a method of taking natural-color photos of the vitreous, retina, optic nerve, choroid, etc. using a camera, and is an important test for patient diagnosis and health promotion. In recent years, fundus photography has been performed in various ways such as red-free ophthalmoscopy, blue reflectance image, near-infrared image, and fundus autofluorescence image (FAF) using various filters or Scanning Laser Ophthalmoscope (SLO). 
    Optical coherence tomography (OCT) is a diagnostic technique that obtains information from the inside of tissues by measuring the difference in intensity and the delay in echo time of the reflected light after shining a certain wavelength of light on the tissue, and then recombines it into a two-dimensional or three-dimensional image to observe the cross-section of the tissue in high resolution at the micrometer level. OCT has the great advantage of being able to observe changes in retinal cross-section in vivo at high resolution due to disease progression and treatment, and it also has the advantage of being able to make objective and quantitative measurements in a short time with less inter-observer variation than other tests.
    Optical coherence tomography and optical coherence tomography angiography (OCTA) have been widely used for choroidal vascular assessment because they are noninvasive methods of imaging choroidal blood flow and retinal structures and reduce patient discomfort compared to fluorescein angiography, which uses contrast media. Fluorescein angiography and indocyanine angiography, which use contrast media to determine the vascular status of the retina and choroid, are being used more frequently as scanning laser ophthalmoscopy and wide-field technology have improved.
    This study aims to evaluate the clinical efficacy of a multifunctional ophthalmic diagnostic imaging device developed with the support of Korea Medical Device Development Fund (KMDF) by comparing and analyzing fundus photographs, optical coherence tomography, and optical coherence angiography images taken with existing commercially available ophthalmic imaging equipment.
    The study will include 14 adults with healthy eyes and 42 adults with diseased eyes. After obtaining written informed consent from all study participants, refraction, visual acuity, intraocular pressure, anterior segment examination with slit lamp, and fundus examination will be performed. Only eyes that meet the pre-selected criteria will be scanned with the test and control devices.
    This is a single-group, open-label clinical trial with no randomization or blinding, and participants will only visit once and complete the study in one day.
    Participants are aware that both control and test devices will be applied, and investigator make an arbitrary order of application of the control and test devices.
    After the test is completed, compare and analyze the image quality of fundus color images, fundus autofluorescence images, optical coherence tomography images, and optical coherence angiography images obtained from the test device and the control 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 Cohort
    Time Perspective Cross-sectional  
    Target Number of Participant 56
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Those who need to take a fundus photography.

    Cohort/Group Description

    Scanning Laser Ophthalmicscope color image(SLO color image)
    Fundus AutoFluorescence image(FAF image)
    Optical Coherence Tomogrphy image(OCT image)
    Optical Coherenece Tomography Angiography(OCTA image)
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients who need to take fundus photographs due to eye diseases such as retinal disease or glaucoma and who need to take fundus photographs for eye exam.
    
    Sampling Method
    Sample size based on a commercially available fundus camera with a sensitivity of 75%, specificity of 94%, and a dropout rate of 10%.
    (14 healthy eyes and 42 diseased eyes were recruited).
    People who have given written consent to participate in the study and meet predefined inclusion/exclusion criteria.
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H35.3)Degeneration of macula and posterior pole 

    Condition which need to take fundus photographs due to eye diseases such as retinal disease or glaucoma and who need to take fundus photographs for eye exam.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~80Year

    Description

    1) Healthy eyes
    - Adults between the ages of 19 and 80 years old
    - Those who have given written consent to participate in the study
    - General healthy eyes: Spherical Equivalent within ±6.00D, corrected visual acuity of 0.25 or better, intraocular pressure of 21mmHg or less, no clinically significant abnormal findings in the anterior segment/ fundus, eye without a surgery(excluding cataracts and refractive surgery) and ocular diseases eyes that will not effect the result under investigator's decision.
    
    2) Ocular disease eyes
    - Adults between the ages of 19 and 80 years old
    - Those who have given written consent to participate in the study
    - subjects who require fundus photography due to eye disease such as retinal disease or glaucoma.
    Exclusion Criteria
    1) Pregnant and lactating women
    2) Eyes with a media opacity(corneal opacity, severe cataract, vitreous opacity, etc.) that  may affect the result by the investigator's decision.
    3) Eyes deemed inappropriate by the investigator.
    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
    Sensitivity and specificity of retinal abnormalities in Scanning Laser Ophthalmicscope color image
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 1
    Outcome
    Agreement of abnormalities on macular disease between scanning laser ophthalmicscope color images of test device and control device
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 2
    Outcome
    Image quality of the test device in scanning laser ophthalmoscope color images
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 3
    Outcome
    Sensitivity and specificity of abnormalities on scanning laser ophthalmoscopy fundus autofluorescence images 
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 4
    Outcome
    Agreement of retinal abnormalities on scanning laser ophthalmoscope fundus autofluorescence images between test and control devices
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 5
    Outcome
    Image quality of the test device in scanning laser ophthalmoscopy fundus autofluorescence images
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 6
    Outcome
    Central macular thickness and Segmentation Error in Optical Coherence Tomography Images
    Timepoint
    Within 12 months of study completion
    Secondary Outcome(s) 7
    Outcome
    Regional vessel density of superficial capillary plexus layer in optical coherence tomography angiography
    Timepoint
    Within 12 months of study completion
  • 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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