Preloaded DMEK With Endothelium Outward: A Multicenter Clinical Study Using DMEK Rapid Device
Gabriela Wójcik, Mohit Parekh, Vito Romano, Alessandro Ruzza, Vincenzo Scorcia, P. Viola, Pia Leon, Antonella Franch, Kunal A. Gadhvi, Diego Ponzin, Stefano Ferrari
Abstract
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/mm 2 ) ( P < 0.001) compared with the preoperative value (2503 ± 128 cells/mm 2 ), 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.