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KMID : 1137820190400060250
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의공학회지
2019 Volume.40 No. 6 p.250 ~ p.259
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A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System
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Kim You-Rim
Yu Woo-Jin
Park Ho-Joon
Jang Won-Seuk
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Abstract
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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.
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KEYWORD
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Ophthalmic laser, Safety and performance, Clinical effectiveness, Evaluation
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