Corneal Storage Media with Amphotericin-B: Results from a Prospective Laboratory Study Submitted for Class 2 De Novo 510(k) Premarket Approval

PURPOSE
To compare endothelial cell density and morphometry, thickness, and transparency of corneas stored in Kerasave vs. Optisol-GS for 14 days.

METHODS
Mate corneas were recovered into Kerasave or Optisol-GS (27 pairs) and stored at 2-8°C for 14 days.
Endothelial cell density (ECD), hexagonality (HEX), and coefficient of variation (CV) were evaluated by specular microscopy, and central corneal thickness (CCT) was examined by OCT after 1, 3, 7, and 14 days of storage. Corneal transparency was scored using slit-lamp examination at days 1 and 14.

RESULTS
Average ECD, HEX, and CV for the Kerasave (2653±303, 57±4, 36±3) and Optisol-GS (2623±306, 57±5, 36±4) groups were not significantly different at day 1. There was also no difference at any other study timepoints (P>0.05 for all). ECD did not significantly change from day 1 to day 14 in either group (P>0.05), but a statistically significant change in HEX and CV was observed between day 1 and day 14 in both groups (P<0.01). Average CCT measured at day 1 for corneas stored in Kerasave was 622±49 and those stored in Optisol-GS was 580±35 (P<0.01). The difference in CCT measurements was not significant different at day 14 (674±46 v. 647±58, P>0.05). Corneal transparency was not significantly different between the two groups at day 1 or day 14.

CONCLUSION
Endothelial cell density, endothelial morphometry, and corneal transparency were not different in corneas stored in Kerasave or Optisol-GS for 14 days.
Optisol-GS was initially better at thinning the cornea than Kerasave. These results suggest that Kerasave is a viable alternative to Optisol-GS for corneal storage.