Assessment of performance and safety of Corneal Chamber hypothermic storage medium and PSS-L corneal rinsing solution in human and porcine corneas
Laura Giurgola,
Umberto Rodella,
Claudio Gatto
et al.
Abstract:PurposeTo prove the safety and performance of the hypothermic corneal storage medium "Corneal Chamber" and the rinsing solution "PSS-L" in support of the newConformité Européenne(CE) certification process in accordance with the Medical Device Regulation.MethodsFifteen (n=15) human donor corneas and 11 (n=11) porcine corneas were evaluated for the following parameters: endothelial cell density (ECD) and mortality, percentage of hexagonal cells (HEX%), coefficient of cellular area variation (CV%) and corneal tra… Show more
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