The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • V-Check

Treatment groups

135 Participants
are divided into 1 treatment group