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KMID : 1011420180230010011
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Journal of Korean Ophthalmic Optics Society
2018 Volume.23 No. 1 p.11 ~ p.18
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A Evaluation of Biological Safety in Risk Management of Conventional Contact Lens Containing Phosphorylcholine
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Cho Seung-Kwon
Park Ji-Hoon
Lim Gyun-Tack
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Abstract
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Purpose: The aim of this study is to evaluate the degree of cytotoxic response in terms of risk management by conducting in vitro cytotoxicity test as a part of securing the biological safety of soft contact lens containing phosphorylcholine (PC).
Methods: A hydrogel-type soft contact lens was prepared from 2-HEMA (2-hydroxyethyl methacrylate) as a representative of the basic skeleton of soft contact lenses, and PC as a derivative of phospholipid. As part of ensuring biological safety, the packaging and sterilization process was performed to evaluate the cytotoxicity test, and the test was conducted in the state of the finished product. The cytotoxicity tests were evaluated by extraction method (direct contact), growth inhibition test and agar diffusion test method.
Results: In the extraction test method, The reagent control and negative control did not show cytotoxicity (Grade 0) and the positive control showed cytotoxicity more than medium (>Grade 2). In qualitative analysis, 10% of Confluent monolayer, 10% of Growth inhibition, 10% of Cells without intracellular granulation, 10% of Rounding, 10% of Lysis and Reactivity of Slight were observed with Grade 1. The effluent of the substance may be said to have very weak reactivity to cultured cells. Cell viability was 106.8% for MTT, 100% for blank test, 2.4% for positive control, and 106.5% for negative control. No cell death or morphological changes were observed in the test group treated with the test substance after 24 hours of incubation by microscopic observation. In the agar diffusion test method, no discoloration zone was observed on the middle layer of the cells to which the test substance was administered, and no cell lysis was observed in the lower part of the specimen. Reactivity zone was not observed in the middle layer of the solvent control and negative control, and the positive control group had a reactivity zone of 0.5 cm or more as expected.
Conclusions: The biological stability of hydrogel-type soft contact lenses consisting of PC and 2-HEMA was evaluated in terms of risk management in order to achieve the intended performance in the design development process. In addition, no cytotoxic substances have been eluted in the production of corneal epithelium, and no adverse effects due to irritation or immune response on the corneal surface are expected.
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KEYWORD
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Cytotoxicity, Phosphorylcholine, Soft contact lens
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