J Korean Ophthalmol Soc > Volume 56(11); 2015 > Article
Journal of the Korean Ophthalmological Society 2015;56(11):1692-1698.
DOI: https://doi.org/10.3341/jkos.2015.56.11.1692    Published online November 15, 2015.
Comparison and Investigation of the National Standards for Tinted Contact Lenses between Various Countries.
Sang Ah Kim, Ji Won Jung, Kyoung Yul Seo, Hyung Keun Lee, Eung Kweon Kim, Tae Im Kim
1The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Korea. taeimkim@gmail.com
2Department of Ophthalmology, Inha University School of Medicine, Incheon, Korea.
컬러콘택트렌즈 기준규격에 관한 국가 간 비교 및 고찰
김상아1⋅정지원2⋅서경률1⋅이형근1⋅김응권1⋅김태임1
연세대학교 의과대학 안과학교실 시기능개발 연구소1, 인하대학교 의과대학 안과학교실2
Received: 27 March 2015   • Revised: 6 July 2015   • Accepted: 4 September 2015
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.
Key Words: Elusion test;International organization for standardization;Ministry of Food and Drug Safety;Standard for tinted soft contact lenses;Tinted contact lenses


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