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KMID : 1159320160180020183
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Korean Journal of Vision Science
2016 Volume.18 No. 2 p.183 ~ p.196
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Performance Comparison of Released Contact Lens in the Korea : KFDA Approval Data Analysis
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Kim Ki-Sung
Kim Tae-Hun
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Abstract
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Purpose: Wearing contact lenses with low oxygen transmissibility is the cause of corneal complication. Many silicone hydrogel products with high oxygen transmissibility were introduced to the domestic market because they help preventing corneal complications, but the products differ in oxygen transmissibility. The information hasn't been known well because some of the products having no oxygen transmissibility marks on its package had been sold. We intend to examine the
present condition of soft contact lenses sold in the domestic market, through analyzing the approval information of Korea’s Ministry of Food and Drug Safety.
Methods: We analyzed product characteristics of the 131 approved soft contact lenses from Korea’s Ministry of Food and Drug Safety after classifying them, by material in silicone hydrogel and hydrogel, by purpose of use in general product and beauty product, by oxygen transmissibility in Dk/t 12, the lowest oxygen transmissibility needed for the cornea, and in Dk/t 24, the state corneal edema doesn't occur with eyes opened, and in Dk/t 87, the state corneal edema doesn't occur
with eyes closed.
Results: The ratio of domestic hydrogel products with a oxygen transmissibility lower than Dk/t 12 was 67.2%(41 EA), and the ratio of imported hydrogel products with a oxygen transmissibility higher than Dk/t 12 was 85.7%(12 EA). The ratio of domestic silicone hydrogel products with a oxygen transmissibility lower than Dk/t 24 was 73.8%(31 EA), and the ratio of products with a performance below Dk/t 12 was 52.4%(22 EA), thus more than half. The ratio of imported silicone
hydrogel products with a oxygen transmissibility higher than Dk/t 24 was 100%(14 EA), and the ratio of products possible of extended wearing with a performance higher than Dk/t 24 was 42.9%(6 EA).
Conclusions: Even though silicone hydrogel prescription rate increased from 10.0% in 2010 to 24.0% in 2015, Some silicone hydrogel products which are introduced in the domestic market have no information or wrong information of oxygen transmissibility being marked on its package, therefore, careful attention is required to choose them or else it may cause side effects.
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KEYWORD
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corneal edema, contact lens, silicone hydrogel
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