Airaldi, Matteo 
ORCID: 0000-0001-9010-1208, Zheng, Yalin ORCID: 0000-0002-7873-0922, Aiello, Francesco ORCID: 0000-0001-6479-1807, Bachmann, Björn ORCID: 0000-0002-3974-7609, Baydoun, Lamis ORCID: 0000-0002-2324-5268, Ní Dhubhghaill, Sorcha ORCID: 0000-0002-1115-7834, Dickman, Mor M ORCID: 0000-0001-9545-343X, Kaye, Stephen B ORCID: 0000-0003-0390-0592, Fontana, Luigi ORCID: 0000-0003-3877-0417, Gadhvi, Kunal A ORCID: 0000-0002-8706-3922 et al (show 13 more authors)
(2023)
Preoperative surgeon evaluation of corneal endothelial status: the Viability Control of Human Endothelial Cells before Keratoplasty (V-CHECK) study protocol.
BMJ open ophthalmology, 8 (1).
e001361-.
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Preoperative surgeon evaluation of corneal endothelial status the Viability Control of Human Endothelial Cells before Kerato.pdf - Open Access published version Download (1MB) | Preview |
Abstract
<h4>Introduction</h4>The success of keratoplasty strongly depends on the health status of the transplanted endothelial cells. Donor corneal tissues are routinely screened for endothelial damage before shipment; however, surgical teams have currently no means of assessing the overall viability of corneal endothelium immediately prior to transplantation. The aim of this study is to validate a preoperative method of evaluating the endothelial health of donor corneal tissues, to assess the proportion of tissues deemed suitable for transplantation by the surgeons and to prospectively record the clinical outcomes of a cohort of patients undergoing keratoplasty in relation to preoperatively defined endothelial viability.<h4>Methods and analysis</h4>In this multicentre cohort study, consecutive patients undergoing keratoplasty (perforating keratoplasty, Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin DSAEK (UT-DSAEK) or Descemet membrane endothelial keratoplasty) will be enrolled and followed-up for 1 year. Before transplantation, the endothelial viability of the donor corneal tissue will be evaluated preoperatively through trypan blue staining and custom image analysis to estimate the overall percentage of trypan blue-positive areas (TBPAs), a proxy of endothelial damage. Functional and structural outcomes at the end of the follow-up will be correlated with preoperatively assessed TBPA values.<h4>Ethics and dissemination</h4>The protocol will be reviewed by the ethical committees of participating centres, with the sponsor centre issuing the final definitive approval. The results will be disseminated on ClinicalTrials.gov, at national and international conferences, by partner patient groups and in open access, peer-reviewed journals.<h4>Trial registration number</h4>NCT05847387.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Endothelium, Corneal, Endothelial Cells, Humans, Trypan Blue, Corneal Transplantation, Cohort Studies, Multicenter Studies as Topic, Surgeons |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 30 Nov 2023 17:09 |
| Last Modified: | 26 Feb 2024 03:24 |
| DOI: | 10.1136/bmjophth-2023-001361 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3177124 |
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