• Title/Summary/Keyword: Ophthalmic devices

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The Sight Corrective Spectacle Frames as a Medical Devices (의료기기로서의 시력보정용 안경테)

  • Kim, Sang-Hyun;Lim, Yongmoo
    • Journal of Korean Ophthalmic Optics Society
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    • v.12 no.3
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    • pp.143-149
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    • 2007
  • We have compared and analyzed the definition of medical devices, classification, who treats, controls and sales the spectacle frames in South Korea, USA and European Union in this paper. South Korea classifies the spectacle frames as an industrial products while EU and USA regards it them as the medical devices. Sunglasses are industrial products in South Korea and EU but they are still the medical devices in USA. Assignment of spectacle frames and sunglasses as an industrial products could bring into several problems. Restricted classification of medical devices on spectacle frames and sunglasses will resolve the problem mentioned.

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A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system (시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로)

  • Kim, Byung Gwan;Choi, Young Sook;Kim, Mi Sun;Yang, Seok-Jo
    • Journal of Biomedical Engineering Research
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    • v.41 no.1
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    • pp.35-41
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    • 2020
  • In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

Growth of Electrochemical Nickel Thin Film on ITO(Indium Tin Oxide) Electrode (ITO(Indium Tin Oxide) 전극상의 전기화학적 Nickel 박막형성)

  • Kim, Woo-Seong;Seong, Jeong-Sub
    • Journal of Korean Ophthalmic Optics Society
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    • v.7 no.2
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    • pp.155-161
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    • 2002
  • We studied the formation of nickel nano thin film that have various electrochromic properties. Nickel thin film having various thickness will apply photoelectronic devices, specially, electrochromic devices. These devices will apply lens, battery, glass and solar cell that have light, thin, simple and small that applied nanotechnology and quantum dot. Nickel thin film was coated by electrochemical method on ITO electrode. We studied the thin film properties by Cyclic voltammetry, Chronoamperometry. Impedance. X-ray diffraction analysis and Atomic force microscopy.

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Protein Absorption and Characterization of Hydrogel Polymer Containing 2-Methacryloyloxyethyl Phosphorylcholine as Additive

  • Kim, Duck-Hyun;Sung, A-Young
    • Journal of Integrative Natural Science
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    • v.9 no.4
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    • pp.249-254
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    • 2016
  • This study evaluated the physical and optical characteristics of hydrophilic ophthalmic polymer with addition of 2-methacryloyloxyethyl phosphorylcholine in the basic hydrogel ophthalmic lens material, and in particular, the utility of 2-methacryloyloxyethyl phosphorylcholine as an ophthalmic contact lens material for ophthalmologic devices was investigated. In this study 2-methacryloyloxyethyl phosphorylcholine were used as additives. For the preparation of hydrogel lens 2-hydroxyethyl methacrylate, methyl methacrylate, acrylic acid and a cross-linker EGDMA were copolymerized in the presence of AIBN as an initiator. The physical properties of the produced polymers were measured as followings. The refractive index of 1.433~1.393, water content of 35.95~53.16%, contact angle of $70.6{\sim}51.24^{\circ}$, UVB transmittance of 81.2~82.4%, UV-B transmittance of 81.2~82.4% and visible transmittance of 91.4~92.2% were obtained. Also, in case of protein absorption, the measurement showed that absorbance of Reference and MPC-10 sample was 0.2598 and 0.2250 respectively. Based on the results of this study, ophthalmic lens material containing 2-methacryloyloxyethyl phosphorylcholine is expected to be used usefully as a material for high wettability and inhibitor of protein adsorption for ophthalmic hydrogel lens.

Study on properties and preparations of Contact Lens Using Additive (첨가제를 이용안 콘택트렌즈의 제조와 특성에 관한 연구)

  • Sung, A-Young
    • Journal of Korean Ophthalmic Optics Society
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    • v.10 no.4
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    • pp.261-266
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    • 2005
  • Quaternary ammonium compounds(QACs) are some of the most commonly used antimicrobials. Antimicrobial polymers have been used as biomedical devices. In this Study, We synthesized new methacrylate monomers including quaternary ammonium moieties for preparation of contact lens, And also, we tested for antimicrobial activities against S. aureus, E. coli and P. aeruginosa. They showed much higher antimicrobial activities against all than the polymers of no including quaternary ammonium.

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Program Development for Extracting the Numerical Data of Aspherical Surface for the Core Manufacturing of Ophthalmic Lens (안경렌즈 코아 가공을 위한 비구면 형상 도출 프로그램 개발)

  • Lee, Dong-Hee
    • Journal of Korean Ophthalmic Optics Society
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    • v.12 no.4
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    • pp.87-90
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    • 2007
  • To manufacture the lens mold used in producing polycarbonate (PC) lenses, the core manufacturing is needed and this core manufacturing is generally performed by diamond turning machine (DTM) or computer numerical control (CNC) lathe. The numerical data about the lens core feature is necessarily needed for operating of these devices. Therefore, we developed the program which calculate the numerical data about the lens core feature. The program was composed to be able to input aspherical coefficients of lens feature, display the graph of lens feature, and save the numerical data file.

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The Corneal Effects Induced by Ultraviolet Radiation (자외선에 의한 각막의 영향)

  • Kim, Douk Hoon
    • Journal of Korean Ophthalmic Optics Society
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    • v.7 no.2
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    • pp.229-234
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    • 2002
  • The human eye and skin is exposed daily to solar energy. Expecially, the ultraviolet radiation (UVR) exposure has been damaged as an important causative factor in corneal disease. These damage of cornea was effected the retina. Therefore the eye function was effected very significant damage. As a results the protect of UVR in the eye is very important in ocular health. Therefore in living the intensive ultraviolet radiation environment by solar energy, human eye have protected the cornea and eyeball by the UV-blocking sunglass, eyeglass, goggles, and contact lens. Finally the specific UV-blocker lens devices available to the primary care for the subjects by optician. Of course, in the future these specific lenses have to development and study by fellowship.

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Optical properties of ink color filters (잉크 색상 필터의 광학적 특성)

  • Lee, Chan-Ku;Lee, Su-Dae
    • Journal of Korean Ophthalmic Optics Society
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    • v.8 no.1
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    • pp.23-28
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    • 2003
  • We report a switchable RGB color filters for Lab on a chip. Ink color filter devices are fabricated by PDMS patterning process. The optical transmission in the ultra-violet and visible wavelengths of color filters have been investigated. The ink color filters are characterised by the slope and shape of the spectrum. The transmission of red/yellow filter consists of curves with a sharp cut-off spectrum at 600 and 500 nm. The blue output of the ink filter has 80% peak transmission and weak red-leak, while the green ink filter has 48% peak transmission and red-leak.

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Implementation of Cost-effective Common Path Spectral Domain Free-hand Scanning OCT System

  • Shoujing Guo;Xuan Liu;Jin U. Kang
    • Current Optics and Photonics
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    • v.7 no.2
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    • pp.176-182
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    • 2023
  • Optical coherence tomography (OCT) is being developed to guide various ophthalmic surgical procedures. However, the high cost of the intraoperative OCT system limits its availability mostly to the largest hospitals and healthcare systems. In this paper, we present a design and evaluation of a low-cost intraoperative common-path free-hand scanning OCT system. The lensed fiber imaging probe is designed and fabricated for intraocular use and the free-hand scanning algorithm that could operate at a low scanning speed was developed. Since the system operates at low frequencies, the cost of the overall system is significantly lower than other commercial intraoperative OCT systems. The assembled system is characterized and shows that it meets the design specifications. The handheld OCT imaging probe is tested on multilayer tape phantom and ex-vivo porcine eyes. The results show that the system could be used as an intraoperative intraocular OCT imaging device.

A Comparison Study on Consumer and Optometrist Perception Toward a Conversion into Medical Devices of Spectacle Frame (안경테의 의료기기 전환에 대한 소비자와 안경사의 인식 비교연구)

  • Han, Sun-Hee;Kim, Bong-Hwan;Kim, Hak-Jun;Kim, So-Yeoun;Lee, Hae-Ri;Kim, Dong-Ho;Jeon, Jun-Woo;Ha, Na-Ri
    • Journal of Korean Ophthalmic Optics Society
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    • v.20 no.1
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    • pp.15-23
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    • 2015
  • Purpose: This study was investigated consumers' and optometrists' perception about spectacle frame in Busan and Ulsan to find on the right progress direction for conversion of spectacle frame into medical devices. Methods: 137 consumers surveyed in Busan and Ulsan and 100 optometrist surveyed in 'Busan continuing education of optometrist' filled in a questionnaire, then we compared and analyzed the results. Results: The 79% (108 people) of consumers and 94% (94 people) of optometrists agreed to conversion into medical devices of spectacle frame. The reason was shown that the consumer expected to improve the optometrist reliability and the optometrist expected to improve the optometrist professionalism. While, the 21% (29 people) consumer and 6% (6 people) optometrist opposed to conversion of spectacle frame into medical devices. The reason was revealed that the consumers were concerned about increase of medical insurance cost and the optometrists were concerned about that the spectacle frames can also be sold by medical device stores, not only by optical shops. Conclusions: The result of the survey was shown that the most of consumers and optometrists in Busan and Ulsan agreed on perception toward a conversion of spectacle frame into medical devices. But, we are considered that consumers' and optometrists' active attention and support are needed, with sequential implementation reflecting the concerns for this.