Assessing the health of donor corneal cells before transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international cohort study aims to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues intended for transplantation. The study will correlate the health of corneal endothelial cells, evaluated by the surgical team, with long-term functional and structural outcomes in patients receiving these tissues. The method involves using Trypan Blue, a vital dye, to independently assess endothelial cell viability, which is crucial for successful corneal graft function. This approach seeks to improve the accuracy of donor tissue evaluations and enhance transplantation outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  Brescia, Bs, Italy Recruiting
• Antwerp University Hospital
  Edegem, Belgium Not yet recruiting
• Department of Ophthalmology, University of Cologne
  Cologne, Germany Not yet recruiting
• Münster University Hospital
  Münster, Germany Not yet recruiting
• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Italy Not yet recruiting
• Department of Medical and Surgical Sciences, University Magna Græcia
  Catanzaro, Italy Not yet recruiting

Study contacts

• Principal investigator: Vito Romano, MD — Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Study coordinator: Matteo Airaldi, MD
• Email: matteo.airaldi@unibs.it
• Phone: +390303995847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.