Analysis for oxygen permeability of cosmetic silicone hydrogel contact lens in Korea

Abstract

Background/Objectives: To investigate the oxygen permeability of cosmetic silicone hydrogel contact lenses in the market in order to describe the current situation for consumers and provide recommendations for guidelines to prevent side effects.Methods/Statistical analysis: I consumers due to information such as the oxygen permeability, water content, and thickness of cosmetic silicone hydrogel contact lenses was collected from websites for the Ministry of Food and Drug Safety and retail stores that sell contact lenses. Descriptive and correlational analyses were performed to determine whether contact lens met high oxygen permeability standards set by the International Organization for Standards(ISO) as well as standards suggested by Holden & Mertz and Harvitt & Bonanno. Findings: Cosmetic silicone hydrogel contact lenses were first approved in 2004. Out of the 270 brands of lenses (21 types) we identified, 119 brands (6 types) provided consumers with no information on oxygen permeability because they had been approved before September 2012. Only one brand of lenses (4.8%) had oxygen permeability levels that met ISO 18369-1:2017 standards. Testing revealed that correlations between the oxygen permeability and water content of cosmetic silicone hydrogel contact lenses on the market were strong at 0.555 (p = 0.009). This correlation does not meet ISO standards and shows that there is no relationship between the oxygen permeability and water content of lenses. Samples examined by the Consumers Union of Korea show that oxygen transmissibility values were significantly below standards at 14.38Dk, 8.86Dk, and 14.14Dk, and that lenses made of silicone hydrogel material performed poorly. The low quality of silicone hydrogel lens attributable to the lack of standards, and the lack of testing for oxygen permeability by the government during routine sample collections/examinations is a problem. Because side effects related to contact lens use are predicted to rise in Korea as long-term use of contacts continues to increase, and use of cosmetic contact lenses for young women in particular continues to grow, revised standards and improved sample collections/examination criteria are necessary. Improvements/Applications: Because only one brand of lens we reviewed (4.8%) met current ISO standards and owing to the difficulty we had identifying the oxygen permeability of lenses, careful attention by consumers, mandatory reporting of oxygen permeability and water content levels by manufacturers, and improved standards for silicone hydrogel contact lenses are needed.