대한의용생체공학회:의공학회지 (Journal of Biomedical Engineering Research)

  • 제40권6호
  • /
  • Pages.250-259
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  • 2019
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  • 1229-0807(pISSN)
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  • 2288-9396(eISSN)
대한의용생체공학회 (The Korean Society of Medical and Biological Engineering)
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다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구

A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System

  • 김유림 (연세대학교 의과대학 의료기기산업학과) ;
  • 유우진 (한국산업기술시험원 의료헬스본부 의료기기연구센터) ;
  • 박호준 (한국산업기술시험원 의료헬스본부 의료기기심사센터) ;
  • 장원석 (연세대학교 의과대학 의료기기산업학과)
  • Kim, You Rim (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Yu, Woo Jin (Medical Device Research Center, Korea Testing Laboratory) ;
  • Park, Ho Joon (Technical Document Review Center, Korea Testing Laboratory) ;
  • Jang, Won Seuk (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
  • 투고 : 2019.10.07
  • 심사 : 2019.12.06
  • 발행 : 2019.12.31
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초록

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.

키워드

참고문헌

  1. Kim CY, et al. Prevalence and characteristics of glaucoma among Korean adults. Korean J Ophthalmol. 2011;25(2):110-5. https://doi.org/10.3341/kjo.2011.25.2.110
  2. Jung YH, et al. Glaucoma pathogenesis and lifestyle modification. J Korean Med Assoc. 2017;60(12):978-982. https://doi.org/10.5124/jkma.2017.60.12.978
  3. Kim CY, et al. Treatment patterns and medication adherence of patients with glaucoma in South Korea. Br J Ophthalmol. 2017;101:801-7. https://doi.org/10.1136/bjophthalmol-2016-308505
  4. Asia-pacific Glucoma Society. Asia Pacific Glaucoma Guidelines 3rd ed. Amsterdam: Kugler Publications; 2016. pp. 1-156.
  5. Paolo Lanzetta, et al. Immediate intraocular pressure response to selective laser trabeculoplasty. Br J Ophthalmol. 1999;83:29-32. https://doi.org/10.1136/bjo.83.1.29
  6. Seong MCl, et al. The Effectiveness of Selective Laser Trabeculoplasty in Steroid-Induced Ocular Hypertension. J Korean Ophthalmol Soc. 2011;52(7):876-880. https://doi.org/10.3341/jkos.2011.52.7.876
  7. Lim KM, Song TJ. A Study on Classification and Differential Grade Management for Medical Devices. J Biomed Eng Res. 2018;39(6):268-77. https://doi.org/10.9718/JBER.2018.39.6.268
  8. Kim JY, Noh SC, Choi HH, et al. A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device. J Biomed Eng Res. 2015;36(5):162-8. https://doi.org/10.9718/JBER.2015.36.5.162
  9. Regulation on Medical Device Groups and Class by Group, Ministry of Food and Drug Safety Public Notification No. 2017-6.
  10. FDA, Code of Federal Regulation 21, Part 886 Ophthalmic devices, 8886.4390 Ophthalmic laser.
  11. Global Medical Device Nomenclature Database, GMDN Agency. Accessed on 20 Aug 2019.
  12. Pmda, English edition of Japanese Medical Device Nomenclature (JMDN). As of Sep, 2018.
  13. https://emed.mfds.go.kr/#!CECAB01F010. Accessed on 19 July 2019.
  14. Common Standards and Specifications on Electromechanical Safety of Medical Devices, Ministry of Food & Drug Safety Public Notification No. 2015-115.
  15. Common Standards and Specifications on Electromagnetic Safety of Medical Devices, Ministry of Food & Drug Safety Public Notification No. 2017-45.
  16. Common Standards and Specifications on Biological Safety of Medical Devices Ministry of Food & Drug Safety Public Notification No. 2019-4.
  17. https://clinicaltrials.gov/. Accessed on 20 Aug 2019.
  18. Park JJ, Shao J, Lee JW, Lee KW. Comparison of Clinical Outcomes of Argon Laser Versus Selective Laser Trabeculoplasty in POAG. J Korean Ophthalmol Soc. 2008;49(9):1491-500. https://doi.org/10.3341/jkos.2008.49.9.1491
  19. Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research 2nd ed. Boca Raton, Florida: Chapman & Hall/CRC;2008. pp. 1-449.