The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.
Age older than 18 years old
Planned corneal transplantation: perforating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)
Indication for corneal transplantation (low-moderate risk of rejection): keratoconus, Fuchs endothelial dystrophy
Ability to provide written informed consent.
Prior corneal transplantation
Planned preloaded DSAEK or preloaded DMEK
Planned keratoplasty not involving corneal endothelium transplantation (i.e., superficial/deep anterior lamellar keratoplasty)
Evidence of concurrent microbial keratitis
Consecutive patients undergoing keratoplasty at participating referral cornea clinics
Cohort
Prospective
V-Check
Diagnostic testPreoperative analysis of endothelial tissue staining with vital dye (Trypan Blue 0.05%) and image analysis to identify the percentage of Trypan Blue Positive Areas, corresponding to dead endothelial cells and/or denuded areas of endothelium, in tissues destined to keratoplasty
Trypan Blue Positive Areas (TBPA) percentage and Donor mortality
The comparison of the endothelial mortality of included donor corneas measured preoperatively (TBPA) and the overall endothelial mortality as declared by the eye bank providing the tissue
Correlation of TBPA to declared endothelial cell density (dECD)
Spearman's rank correlation coefficient of TBPA and declared Endothelial Cell Density (dECD) as provided by the Eye Bank supplying the tissue
Correlation of TBPA to declared endothelial mortality on corneal folds
Spearman's rank correlation coefficient of TBPA and declared Endothelial Cell mortality on corneal folds as provided by the Eye Bank supplying the tissue
Final ECD
Final ECD of transplanted corneas at 12 months
Rate of endothelial cell loss
Rate of change of ECD over the course of the entire follow-up
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