안과용 스펀지가 배양된 인체 결막상피세포에 미치는 안전성 평가

Abstract

Purpose Ophthalmic sponges are used to remove and check bleeding or fluid leakage that occurs during refractive surgery, corneal and anterior segment surgery. In order to confirm the safety of the ocular sponge Occucell® (OccuTech Inc, Seongnam, Korea), the biological safety was compared and analyzed with pre-existing products.

Materials and Method To evaluate the biological safety of the ophthalmic sponge, extracts were conducted to evaluate cytotoxicity on four products, Occucell®, a brand-new product, pre-existing products, Ultracell®, Eyetec-1 and Eyetec-2. Human conjunctival epithelial cells cultured in 96 well plates with the elution from tertiary distilled water at concentration of 1%, 5%, and 10%, and ethanol and DMSO at 1%, 1.5%, and 2% concentrations, respectively. Cell viability was measured through 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide(MTT) analysis. Live & dead cell staining was observed using a fluorescence microscope. To confirm the effect on IL-1β and TNF-α expression, 0.5% DMSO eluate was treated with cultured human conjunctival epithelial cells to conduct real-time polymerase chain reaction and mRNA expression levels were compared.

Results In the MTT analysis, there was no significant difference between Occucell®, compared with pre-existing products. Human conjunctival epithelial cells showed more than 90% viability. In addition, there was no significant difference compared to the control group in live & dead cell staining and relative mRNA expression of IL-1β and TNF-α.

Conclusion Occucell®, an ophthalmic sponge used during ophthalmic surgery in clinical practice, shows more than 90% viability of human conjunctival epithelial cells after treatment with the elution. It is thought to be safe to use as it does not show any significant difference from the pre-existing products.