Purpose: To evaluate factors affecting the outcomes of preloaded Descemet membrane endothelial keratoplasty (pl-DMEK) with endothelium-inward.
Design: Retrospective clinical case series and a comparative tissue preparation study.
Methods: Participants: Fifty-five donor tissues for ex vivo study and 147 eyes of 147 patients indicated with Fuchs endothelial dystrophy or pseudophakic bullous keratopathy with or without cataract.
Intervention: Standardized DMEK peeling was performed with 9.5-mm-diameter trephination followed by second trephination for loading the graft (8.0-9.5 mm diameter). The tissues were manually preloaded with endothelium-inward and preserved for 4 days or shipped for transplantation. Live and dead assay and immunostaining was performed on ex vivo tissues. For the clinical study, the tissues were delivered using bimanual pull-through technique followed by air tamponade at all the centers.
Main Outcome Measures: Tissue characteristics, donor and recipient factors, rebubbling rate, endothelial cell loss (ECL), and corrected distance visual acuity (CDVA) at 3, 6, and 12 months.
Results: At day 4, significant cell loss (P = .04) was observed in pl-DMEK with loss of biomarker expression seen in prestripped and pl-DMEK tissues. Rebubbling was observed in 40.24% cases. Average ECL at 3, 6, and 12 months was 45.87%, 40.98%, and 47.54%, respectively. CDVA improved significantly at 3 months postoperation (0.23 ± 0.37 logMAR) (P < .01) compared to the baseline (0.79 ± 0.61 logMAR). A significant association (P < .05) between graft diameter, preservation time, recipient gender, gender mismatch, and recipient age to rebubbling rate was observed.
Conclusion: Graft loading to delivery time of pl-DMEK tissues in endothelium-inward fashion must be limited to 4 days after processing. Rebubbling rate and overall surgical outcomes following preloaded DMEK can be multifactorial and center-specific.
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