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컬러콘택트렌즈 기준규격에 관한 국가 간 비교 및 고찰

Other Titles
 Comparison and Investigation of the National Standards for Tinted Contact Lenses between Various Countries 
Authors
 김상아  ;  정지원  ;  서경률  ;  이형근  ;  김응권  ;  김태임 
Citation
 Journal of the Korean Ophthalmological Society (대한안과학회지), Vol.56(11) : 1692-1698, 2015 
Journal Title
 Journal of the Korean Ophthalmological Society (대한안과학회지) 
ISSN
 0378-6471 
Issue Date
2015
Keywords
Elusion test ; International organization for standardization ; Ministry of Food and Drug Safety ; Standard for tinted soft contact lenses ; Tinted contact lenses
Abstract
Purpose : In this study we investigated the safety level of the national standard for tinted soft contact lenses by comparing the standards in various countries. Methods : To evaluate the current guidelines for tinted soft contact lenses such as form and appearance, diameter, curvature radius, vertex power, cylindrical refractivity and cylindrical axis, luminous/ultraviolet ray (UV) transmittance, moisture content, oxygen permeability coefficient, extractables, elution test, cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity, genotoxicity and biocompatibility safety test using rabbit eyes and sterility test. We compared the standards of International Organization for Standardization (ISO), Food and Drug Administration (FDA) of the United States, Ministry of Health, Labor and Welfare (MHLW) of Japan and Ministry of Food and Drug Safety (MFDS) of Korea. Results : The guidelines for tinted soft contact lenses of ISO, FDA and MFDS are similar to soft contact lenses but MHLW of Japan classifies these lenses and sets specific guidelines. First, the oxygen permeability coefficient measured at 6mm from the center should be maintained over 80%. Also, coloring should not affect the oxygen permeability coefficient significantly. Regarding the physical (form and appearance, diameter, curvature radius, moisture content) and optical (vertex power, cylindrical refractivity and cylindrical axis, luminous/UV transmittance, oxygen permeability coefficient) characteristics, no differences were found between ISO and MFDS. However, several differences were found in chemical characteristics (extractables, elution test) and biological stability (cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity test, genotoxicity, biocompatibility safety test using rabbit eyes, sterility test). For example, the elution test is required only by MFDS. Conclusions : The reinvestigation into the effectiveness of the elution test is needed and new evaluation measures including scanning electron microscopy and atomic force microscopy designed for tinted soft contact lenses to evaluate the size of the optical area, the location and roughness of the pigmented layer are required.
Files in This Item:
T201504519.pdf Download
DOI
10.3341/jkos.2015.56.11.1692
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Ophthalmology (안과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Sangah(김상아) ORCID logo https://orcid.org/0000-0002-8511-2903
Kim, Eung Kweon(김응권) ORCID logo https://orcid.org/0000-0002-1453-8042
Kim, Tae Im(김태임) ORCID logo https://orcid.org/0000-0001-6414-3842
Seo, Kyuong Yul(서경률) ORCID logo https://orcid.org/0000-0002-9855-1980
Lee, Hyung Keun(이형근) ORCID logo https://orcid.org/0000-0002-1123-2136
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/156772
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