MedTrace Logo

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

NCT05847387 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

  • Corneal Transplant Failure
  • Corneal Endothelial Cell Loss

Interventions

DIAGNOSTIC_TEST

V-Check

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

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Vito Romano, MD · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-03-30
Completion
2026-09-30

Countries

  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05847387 on ClinicalTrials.gov