Evaluation of safety and effectiveness of a multimodal imaging device HWSO-1 through comparison of various retinal images
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0009101
- Lead Sponsor
- Huvitz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 56
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.
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.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of retinal abnormalities in Scanning Laser Ophthalmicscope color image
- Secondary Outcome Measures
Name Time Method 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