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

Ophthalmology. 2024 Jun;131(6):674-681. doi: 10.1016/j.ophtha.2023.12.027. Epub 2023 Dec 29.

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.

Design: Prospective, randomized, single-center trial conducted in Italy.

Participants: Adult patients (age ≥ 18 years) with keratoconus scheduled for elective DALK.

Methods: Patients undergoing successful type 1 bubble pneumatic dissection using a standard DALK technique were randomized during surgery to receive either dehydrated (n = 30) or standard organ culture-stored (n = 30) donor corneas.

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 BSCVA did not significantly differ between groups at both time points: mean difference at 6 months was 0.030 logarithm of the minimum angle of resolution (logMAR; 95% confidence interval [CI], -0.53 to 0.10 logMAR; P = 0.471) and at 12 months was -0.013 logMAR (95% CI, -0.10 to 0.08 logMAR; 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 patients (33%) in the organ culture cornea group and in 29 patients (97%) in the dehydrated cornea group. Complete re-epithelialization was achieved by day 7 in all patients (100%) in both groups.

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.

Financial disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Keywords: COVID-19; Corneal transplantation; Deep anterior lamellar keratoplasty; Dehydrated cornea; Organ culture storage medium.

Publication types

  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Adult
  • Cell Count
  • Cornea / surgery
  • Corneal Transplantation* / methods
  • Endothelium, Corneal / pathology
  • Female
  • Humans
  • Keratoconus* / physiopathology
  • Keratoconus* / surgery
  • Male
  • Middle Aged
  • Organ Culture Techniques*
  • Organ Preservation* / methods
  • Prospective Studies
  • Tissue Donors*
  • Visual Acuity* / physiology
  • Young Adult