[논문]국내 생산 콘택트렌즈의 물리적 특성 비교 -산소전달률을 중심으로-

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doi:10.15207/jkcs.2018.9.1.393

국내 생산 콘택트렌즈의 물리적 특성 비교 -산소전달률을 중심으로-
Comparison of Physical Properties of Domestic Contact Lenses -Focusing on oxygen transmissibility- 원문보기

한국융합학회논문지 = Journal of the Korea Convergence Society, v.9 no.1, 2018년, pp.393 - 403

김기성 (강원대학교 의과대학 예방의학교실)

초록
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산소전달률이 높은 것으로 알려진 실리콘 하이드로젤 콘택트렌즈의 사용이 증가하고 있지만 함수율과 산소전달률 등 물리적 특성이 표시되지 않은채 판매되고 있다.본 연구에서는 국내에서 허가된 실리콘 하이드로젤 콘택트렌즈의 함수율과 산소전달률 등의 물리적 특성을 분석하기 위하여, 식품의약품안전처 웹사이트에 공개된 허가정보를 수집 분석하였다. 본 연구에서 분석된 국산 실리콘 하이드로젤 콘택트렌즈 68건 가운데 61건(89.7%)이 산소투과성에 관한 국제규격을 만족하지 못하였다. 실리콘 하이드로젤 콘택트렌즈에 대한 국내규격이 부재하여 하이드로젤 콘택트렌즈와 차이가 없는 제품도 실리콘 하이드로젤 콘택트렌즈로 신고되었기 때문으로 판단된다. 앞으로 신고된 정보 뿐만 아니라 유통되고 있는 실리콘 하이드로젤 콘택트렌즈의 물리적 특성에 대한 분석이 요구된다.

Abstract ▼ AI-Helper

Although the use of silicone hydrogel contact lenses which are known to have high oxygen transmissibility is increasing, they are being sold without any product labeling of physical properties such as water content and oxygen transmissibility. To analyze the physical properties such as the water content and oxygen transmissibility of approved silicone hydrogel contact lenses, this study collected and analyzed the approval information published on the KFDA website. Of 68 cases of domestic silicone hydrogel contact lenses analyzed in this study, 61 cases (89.7%) did not meet the international standard for oxygen permeability. This is because lenses that are not different from hydrogel contact lenses were submitted for approval as silicone hydrogel contact lenses because there is no domestic standard for silicone hydrogel contact lenses. In future, besides the information published on the website, analysis of the physical properties of a wide variety of actual silicone hydrogel contact lenses on the market is required.

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제안 방법

Since the oxygen transmissibility is not disclosed on the webpage of the Korea’s Ministry of Food and Drug Safety, it was obtained by calculating the oxygen permeability and thickness of the material which were disclosed on the webpage.
The purpose of this study was to find ways to provide consumers with accurate information to realize their rights to know by analyzing the physical properties such as oxygen transmissibility, water content, light transmittance and ultraviolet transmittance of the silicone hydrogel contact lens, which is known as a product with high oxygen transmissibility among the soft contact lenses disclosed on the website of the Electronic Petitions Window on Medical Devices of Korea’s Ministry of Food and Drug Safety.

데이터처리

, USA), general characteristics were presented by percentage, comparison of the mean values of the ultraviolet cutoff rates was performed by the Mann-Whitney U test, and comparison of the mean values of the oxygen permeability, water content, lens center thickness, and light transmittance was performed by the independent t-test. ANOVA was performed by classifying silicone hydrogels according to their components and the post hoc tests were performed using Tukey HSD. Pearson correlation test was performed to confirm the correlation between water content and oxygen permeability.
As for the collected data, descriptive statistics was presented by IBM SPSS Statistics Ver. 24 (IBM Corp., USA), general characteristics were presented by percentage, comparison of the mean values of the ultraviolet cutoff rates was performed by the Mann-Whitney U test, and comparison of the mean values of the oxygen permeability, water content, lens center thickness, and light transmittance was performed by the independent t-test. ANOVA was performed by classifying silicone hydrogels according to their components and the post hoc tests were performed using Tukey HSD.
ANOVA was performed by classifying silicone hydrogels according to their components and the post hoc tests were performed using Tukey HSD. Pearson correlation test was performed to confirm the correlation between water content and oxygen permeability.

성능/효과

6%) were hydrogel products. 45.6% of the silicone hydrogel products had ultraviolet shielding function and 21.7% of the hydrogel products had ultraviolet shielding function; the ratio of silicone hydrogel products was higher than that of hydrogel products in ultraviolet shielding function.
Among the 46 products with automatic UV blocking function, the average UVA blocking rate was 66.15% and the average UVB blocking rate was 93.82%, which means that the UVB blocking rate was higher than UVA blocking rate. As for the average UVA blocking rate, hydrogels were 58.
004), which showed a significant difference. As a result of post hoc tests, there was a significant difference between PDMS and MPTS (p = 0.003), and also between PDMS and ETC (p = 0.022), but no significant difference between MPTS and ETC (p =.816).
043). As a result of post hoc tests, there was a significant difference in the water content of PDMS and MPTS (p = 0.039), but there was no significant difference (p=0.039) between PDMS and ETC (p = 0.123), and between MPTS and ETC (p =0.640).
025). As for the results of post hoc tests of oxygen permeability, there was a significant difference between PDMS and ETC (p=0.022), but there was no significant difference between PDMS and ETC (p = 0.079) and between MPTS and ETC (p = 0.629) respectively, and in the homogeneous subsets, MPTS and ETC belonged to the same group and PDMS belonged to the other group.
As for the water content, PDMS was 53.67%, ETC was 46.11%, and MPTS was 44.59%; the water content of PDMS was the highest and this was statistically significant (p = 0.043). As a result of post hoc tests, there was a significant difference in the water content of PDMS and MPTS (p = 0.
In this study, approval information of 68 cases of silicone hydrogel contact lenses were analyzed, which showed that only seven products met the international standard for oxygen permeability of such lenses. This was not very different from the previous study that showed there was no difference between the oxygen transmissibility of silicone hydrogel contact lenses and that of hydrogel contact lenses, both of which were domestically approved [25].
The UVA cutoff rate was 80.00% for PDMS, 75.50% for ETC, and 66.43% for MPTS, showing a statistically significant difference (p = 0.016). In the post hoc tests, there was a significant difference between MPTS and ETC (p = 0.
The overall average oxygen transmissibility calculated from the oxygen permeability and the lens center thickness was 17.98; the average oxygen transmissibility of the hydrogel was 14.20, while the average oxygen transmissibility of the silicone hydrogel was 21.52, which showed there was a significant difference between the two product groups (p = 0.007).
The oxygen permeability of PDMS was 45.33, ETC was 21.69, and MPTS was 17.29, which showed the oxygen transmissibility of PDMS was the highest, and this was statistically significant (p = 0.025). As for the results of post hoc tests of oxygen permeability, there was a significant difference between PDMS and ETC (p=0.
When the oxygen permeability was measured only for the products with the center thickness disclosed, PDMS was 45.33, MPTS was 17.45, and ETC was 11.00, and there was a statistically significant difference (p = 0.002). In the post hoc tests, there was a significant difference between PDMS and MPTS (p =0.

후속연구

To analyze the physical properties of the products which are not reported to the Korea’s Ministry of Food and Drug Safety, additional research is needed to analyze such physical properties by directly collecting the soft contact lenses on the market.

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국내 생산 콘택트렌즈의 물리적 특성 비교 -산소전달률을 중심으로-
Comparison of Physical Properties of Domestic Contact Lenses -Focusing on oxygen transmissibility- 원문보기

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국내 생산 콘택트렌즈의 물리적 특성 비교 -산소전달률을 중심으로- Comparison of Physical Properties of Domestic Contact Lenses -Focusing on oxygen transmissibility- 원문보기

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Comparison of Physical Properties of Domestic Contact Lenses -Focusing on oxygen transmissibility- 원문보기

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