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
CRIS Registration Number |
KCT0009101 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Medical Device Development Fund |
Organization Type | Others |
Project ID | RS2020KD000026 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Huvitz |
Organization Type | Others |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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) |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
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. |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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