Prospective, randomized clinical and endothelial evaluation of 2 storage times for cornea donor tissue in organ culture at 31 degrees C

Arch Ophthalmol. 2003 Apr;121(4):442-50. doi: 10.1001/archopht.121.4.442.


Objective: To compare the endothelial and clinical outcome of penetrating keratoplasty with corneas stored in organ culture for up to 12 days (5-12 days; group 1) or more than 21 days (21-24 days; group 2).

Methods: We conducted a controlled double-masked trial. Storage durations were randomly assigned to the paired corneas, and endothelial cell density (ECD) was measured at the start and end of organ culture. Patients with a low rejection risk and preoperative ECD within the reference range were randomly assigned to 1 of the 2 groups and underwent an 8.25-mm penetrating keratoplasty (n = 25 pairs). Follow-up at day 5 and months 1, 6, and 12 included central ECD, morphometry, graft transparency, visual acuity, pachymetry, and complications. The main outcome measure was the central ECD at month 12.

Results: At the end of organ culture, ECD of the group 1 corneas was higher by 273 cells/mm2 (95% confidence interval [CI], 178-368; P<.001). One year after penetrating keratoplasty, the group 1 ECD was still comparably higher by 227 cells/mm2 (95% CI, 43-411; P =.02). Graft transparency, pachymetry, and complication rate did not differ at any time. In group 1, visual acuity was better at month 1.

Conclusions: Shorter organ culture allows delivery of corneas with higher ECD. Recipients with ECD within the reference range and low rejection risk retain this initial benefit 1 year postoperatively. The higher endothelial cell capital may prevent or delay late endothelial failure, the leading cause of graft failure in these recipients. We therefore prefer short-term storage for such recipients.

Publication types

  • Clinical Trial
  • Comparative Study
  • Evaluation Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cell Count
  • Cornea*
  • Cryopreservation*
  • Double-Blind Method
  • Endothelium, Corneal / cytology*
  • Female
  • Graft Survival / physiology
  • Humans
  • Keratoplasty, Penetrating*
  • Male
  • Middle Aged
  • Organ Culture Techniques / methods*
  • Organ Preservation*
  • Prospective Studies
  • Time Factors
  • Tissue Donors
  • Visual Acuity