Preloaded DMEK With Endothelium Outward: A Multicenter Clinical Study Using DMEK Rapid Device.

PURPOSE: The objective of this study is to validate Descemet membrane endothelial keratoplasty (DMEK) Rapid device for preloading DMEK grafts with endothelium outward.

METHODS: In this multicenter retrospective clinical study, DMEK tissues (n = 27) were peeled and preloaded (8.25 mm) in a DMEK Rapid device. The device was loaded in a container prefilled with the storage solution and shipped from a single center in Italy to 4 different centers located in Italy and the United Kingdom. Preloaded tissues were delivered by injecting the graft in the anterior chamber. Patients were monitored at days 1 and 15 and at months 1, 3, and 6, as well as at the last follow-up (9-12 months) postoperatively. Main outcome measures included rebubbling rate and graft failure, corrected distance visual acuity, endothelial cell loss (ECL), and central corneal thickness at all time points. A one-way analysis of variance test comparing day 1 with all later time points was followed with significance at P < 0.05.

RESULTS: The average recorded surgical time was 6 to 25 minutes with no immediate surgical complications. Rebubbling was observed in 7 of 26 cases with one graft failure within 15 days postoperatively. The mean corrected distance visual acuity at day 1 was 0.64 ± 0.49 logMAR, which improved to 0.18 ± 0.43 logMAR at the last follow-up. Endothelial cell density values showed a significant decrease at the last follow-up (1827 ± 565 cells/mm2) (P < 0.001) compared with the preoperative value (2503 ± 128 cells/mm2), with an average endothelial cell loss of 27%. Central corneal thickness significantly dropped from 694 ± 157 μm at day 1 to 502 ± 42 μm at the last follow-up (P < 0.001).

CONCLUSIONS: DMEK Rapid device is quick, easy, and efficient for preloading and shipping DMEK grafts internationally in endothelium-outward orientation.