Skip to content

Evaluation of safety and effectiveness of a multimodal imaging device HWSO-1 through comparison of various retinal images

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
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009101
Enrollment
56
Registered
2024-01-09
Start date
2024-01-02
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Huvitz
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

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.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of retinal abnormalities in Scanning Laser Ophthalmicscope color image

Secondary

MeasureTime frame
Agreement of abnormalities on macular disease between scanning laser ophthalmicscope color images of test device and control device;Image quality of the test device in scanning laser ophthalmoscope color images;Sensitivity and specificity of abnormalities on scanning laser ophthalmoscopy fundus autofluorescence images ;Agreement of retinal abnormalities on scanning laser ophthalmoscope fundus autofluorescence images between test and control devices;Image quality of the test device in scanning laser ophthalmoscopy fundus autofluorescence images;Central macular thickness and Segmentation Error in Optical Coherence Tomography Images;Regional vessel density of superficial capillary plexus layer in optical coherence tomography angiography

Countries

Korea, Republic of

Contacts

Public ContactYoung Ho Kim

Korea University Anam Hospital

kimyh54067@naver.com+82-2-920-5520

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026