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다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구

Other Titles
 A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System 
Authors
 김유림  ;  유우진  ;  박호준  ;  장원석 
Citation
 Journal of Biomedical Engineering Research (의공학회지), Vol.40(6) : 250-259, 2019 
Journal Title
 Journal of Biomedical Engineering Research (의공학회지) 
ISSN
 1229-0807 
Issue Date
2019
Keywords
Ophthalmic laser ; Safety and performance ; Clinical effectiveness ; Evaluation
Abstract
Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Medical Engineering (의학공학교실) > 1. Journal Papers
Yonsei Authors
Chang, Won Seok(장원석) ORCID logo https://orcid.org/0000-0002-4925-3549
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/174863
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