The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Preoperative Surgeon Evaluation of Corneal Endothelial Status: the Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
135 participants
Dec 1, 2023
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria9
- 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
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Interventions
Preoperative 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
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05847387