Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: Prospective Randomized Trial

Purpose: To compare the outcomes of deep anterior lamellar keratoplasty (DALK) using dehydrated versus standard organ culture stored donor corneas for eyes with keratoconus. Design: Prospective, randomized, single-center trial conducted in Italy PARTICIPANTS: Adult patients with keratoconus (≥ 18 years old) with keratoconus scheduled for an elective DALK METHODS: Cases with successful type 1 bubble pneumatic dissection using standard DALK technique were intraoperatively randomized to receive either dehydrated (n=30) or standard organ culture stored donor corneas (n=30). Main outcome measures: The primary study outcome was best spectacle-corrected visual acuity (BSCVA) 12 months after surgery. Secondary outcomes were refractive astigmatism (RA), endothelial cell density (ECD) and complication rates. Results: Postoperative logMAR BSCVA did not significantly differ between groups at both time points (mean difference at 6 months = 0.030 [95%CI: -0.53-0.10] p = 0.471) and at 12 months = -0.013 [95%CI: -0.10-0.08] p = 0.764). No significant differences between groups were observed in terms of postoperative RA and ECD at all time points. In the first 3 days after DALK, an epithelial defect was present in 10 cases (33%) of the organ culture cornea group and in 29 cases (97%) of the dehydrated cornea group. Complete re-epithelialization was achieved by day 7 in all cases (100%) of both groups. Conclusions: The study provides evidence that the use of dehydrated corneas is non-inferior to the use of standard organ culture donor corneas for DALK. Corneal tissue dehydration represents a viable solution that can allow long-term cornea preservation and avoid wastage of unused corneas.