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

Abstract Purpose: To compare the outcomes of deep anterior lamellar keratoplasty (DALK) using dehydrated versus standard organ culture-stored donor corneas for eyes with keratoconus. Methods: In prospective, randomized, single-center, institutionally funded, 2-arm, parallel-group noninferiority clinical trial, adult patients (age ≥18 years) with keratoconus scheduled for elective DALK with successful type 1 bubble pneumatic dissection were randomized during surgery to receive either dehydrated or standard organ culture-stored donor corneas. The primary study outcome was best spectacle-corrected visual acuity (BSCVA) 12 and 24 months after surgery. Secondary outcomes were refractive astigmatism (RA), endothelial cell density (ECD), and complication rates. Results: Postoperative BSCVA did not significantly differ between groups at both time points (p>0.05). No significant differences between groups were observed in terms of postoperative RA and ECD at all time points (p>0.05). In the first 3 days after DALK, an epithelial defect was present in 10 patients in the organ culture cornea group and in 29 patients in the dehydrated cornea group. Complete re-epithelialization was achieved by day 7 in all patients in both groups. No patient developed immune rejection or graft failure within the 24-month follow-up period. Conclusions: The study provides evidence that the use of dehydrated corneas is noninferior 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.