Abstract
Purpose: :
To evaluate the safety and efficacy of Life4C, a new 4C corneal preservation medium and Transend, a new corneal viewing and transport chamber as compared to commercially available Optisol GS and standard storage containers.
Methods: :
In this GLP study, 71 pairs of human corneas were stored in either the test Life4C (LF) or control Optisol GS (OPT) corneal preservation medium, at 2–8C for 14 days. Upon arrival and at 14 days, three central endothelial images (100 cells) were evaluated on a Konan Eyebank KeratoAnalyzer. Corneal endothelial cell density (CD), coefficient of variation (CV), hexagonality (6A) and corneal thickness (CT) measurements were obtained for each cornea. At the end of cold storage, corneas were placed in 120 ml of serumfree medium, incubated at 35C for an additional 14 days and thinned down 1 day at 2–8C in (LF) or (OPT). Corneal evaluations were repeated. Statistical analysis was performed utilizing a repeated measures design ANOVA with a Tukey Multiple comparison post–test.
Results: :
Baseline measurements were not statistically different (P>0.05) between the test and control groups. CD: 2744 +/– 333 (LF) vs 2732 +/– 355 (OPT) cells/mm2; CV: 31.27 +/– 3.54 (LF) vs 31.51 +/– 3.81 (OPT); 6A: 60.93 +/– 7.04 (LF) vs 59.97 +/– 7.22 (OPT); and CT 538.92 +/– 25.10 (LF) vs 540.46 +/– 27.08 (OPT) um. After 14 days cold storage, statistically significant increases in cell density and decreases in corneal thickness were exhibited in the (LF) test group as compared to the (OPT) control group. Coefficient of variation and hexagonality were not statistically different between the two groups. 14 day CD: 2968 +/– 343 (LF) vs 2747 +/– 334 (OPT) cells/mm2, (P < 0.001); CT: 514.84 +/– 21.66 (LF) vs 568.38 +/– 28.63 (OPT) um, (P < 0.001); CV: 33.01 +/– 3.84 (LF) vs 33.06 +/– 4.00 (OPT), (P > 0.05); 6A: 59.06 +/– 6.45 LF vs 59.81 +/– 6.19 (OPT), (P > 0.05). After 28 days storage, statistically significant increases in cell density and decreases in corneal thickness were exhibited in the (LF) test group as compared to the (OPT) control group. Coefficient of variation and hexagonality were not statistically different between the two groups. 28 day CD: 3013 +/– 468 (LF) vs 2633 +/– 480 (OPT) cells/mm2 (P< 0.001); CT: 521.45 +/– 19.16 (LF) vs 566.65 +/– 33.00 (OPT) um, (P < 0.001); CV: 29.80 +/– 3.34 (LF) vs 29.57 +/– 3.72 (OPT) (P > 0.05); 6A: 56.69 +/– 7.06 (LF) vs 55.51 +/– 7.36 (OPT), (P > 0.05).
Conclusions: :
This GLP controlled study demonstrated the safety and efficacy Life4C. Corneas stored in Life4C medium demonstrated a statistically significant increase in endothelial cell density and reduction of corneal swelling after both 14 and 28 days storage as compared to corneas stored in Optisol GS.
Keywords: cornea: storage • cornea: endothelium