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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Evidence of non-infectious or autoimmune keratitis
* Impending or frank corneal perforation
* Uncontrolled, elevated intraocular pressure (IOP)- Previous glaucoma surgery
* Acute or chronic inflammatory/infectious anterior segment uveitis
* Presence of an anterior chamber intraocular lens (IOL) for phakic or aphakic purposes
What they're measuring
1
Trypan Blue Positive Areas (TBPA) percentage and Donor mortality
Timeframe: Preoperative
Trial details
NCT IDNCT05847387
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia