title: Prospective, randomized clinical and endothelial evaluation of 2 storage times for cornea donor tissue in organ culture at 31 degrees C.
abstract: 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.
authors.affiliation: Department of Ophthalmology, University Hospital, and the Cornea Banks, Establissement Français du Sang of Saint-Etienne, Saint-Etienne, France. gilles.thuret@univ-st-etienne.fr
authors.forename: Gilles
authors.initials: G
authors.lastname: Thuret
authors.forename: Christophe
authors.initials: C
authors.lastname: Chiquet
authors.forename: Fabienne
authors.initials: F
authors.lastname: Bernal
authors.forename: Sophie
authors.initials: S
authors.lastname: Acquart
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Romanet
authors.forename: Michel
authors.initials: M
authors.lastname: Mouillon
authors.forename: Harald
authors.initials: H
authors.lastname: Hegelhoffer
authors.forename: Carole
authors.initials: C
authors.lastname: Burillon
authors.forename: Odile
authors.initials: O
authors.lastname: Damour
authors.forename: Jean
authors.initials: J
authors.lastname: Maugery
authors.forename: W John
authors.initials: WJ
authors.lastname: Armitage
authors.forename: Philippe
authors.initials: P
authors.lastname: Gain
mesh_terms: D000328:Adult; D000368:Aged; D002452:Cell Count; D003315:Cornea; D015925:Cryopreservation; D004311:Double-Blind Method; D004728:Endothelium, Corneal / Q000166:cytology*; D005260:Female; D006085:Graft Survival / Q000502:physiology; D006801:Humans; D015948:Keratoplasty, Penetrating; D008297:Male; D008875:Middle Aged; D009924:Organ Culture Techniques / Q000379:methods*; D009926:Organ Preservation; D011446:Prospective Studies; D013997:Time Factors; D014019:Tissue Donors; D014792:Visual Acuity