Cytotoxicity Evaluation

The human retinal pigment epithelium cells culture (ARPE-19 cell line) is useful for testing safety of intraocular medical devices using a direct contact method according to the International Organization for Standardization (ISO).

Following the patented method (P201630708), the cells are exposed directly to product and controls in different time conditions adapted to the clinical  use of each medical device. After exposure time, the products are removed, and cells are washed. Fresh cell culture medium is added, and cell cultures are incubated during 24 and/or 72 hours of post exposure time.

Upon completion of cell culture time, the cell culture medium is removed. Subsequently, the MTT assay is performed. The absorbance readings are measured using a spectrophotometer at a wavelength of 570 nm to obtain the final optical density (OD). The product has cytotoxic potential when the viability decreases < 70%