Universität zu Köln

Wiedemann, Johanna ORCID: 0009-0000-0496-4921, Hos, Deniz, Limburg, Endrik, Zettelmeyer, Ulrike ORCID: 0000-0003-1406-8164, Schiller, Petra ORCID: 0000-0002-9957-1465, Franklin, Jeremy ORCID: 0000-0003-1536-0925, Bachmann, Björn ORCID: 0000-0002-3974-7609, Böhringer, Daniel, Dietrich-Ntoukas, Tina, Fuchsluger, Thomas A., Geerling, Gerd, Lang, Stefan J., Mayer, Wolfgang Johann, Priglinger, Siegfried, Reinhard, Thomas, Seitz, Berthold and Cursiefen, Claus ORCID: 0000-0002-1958-411X (2024). UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial. Trials, 25 (1). pp. 1-15. Springer Nature. ISSN 1745-6215

PDF s13063-024-08011-1.pdf Bereitstellung unter der CC-Lizenz: Creative Commons Attribution. Download (995kB)

Abstract

[Artikel-Nr.: 169] Background: Good vision highly depends on the transparency of the cornea, which is the “windscreen” of the eye. In fact, corneal blindness due to transparency loss is the second most common cause of blindness worldwide, and corneal transplantation is the main cure. Importantly, the cornea is normally avascular but can secondarily be invaded by pathological (blood and lymphatic) vessels due to severe inflammation, and the survival prognosis of a corneal graft mainly depends on the preoperative vascular condition of the recipient’s cornea. Whereas transplants placed into avascular recipient beds enjoy long-term survival rates of > 90%, survival rates significantly decrease in pathologically pre-vascularized, so-called high-risk recipients, which account for around 10% of all performed transplants in Germany and > 75% in lower and middle-income countries worldwide. Methods: This parallel-grouped, open-randomized, multicenter, prospective controlled exploratory investigator-initiated trial (IIT) intends to improve graft survival by preconditioning pathologically vascularized recipient corneas by (lymph)angioregressive treatment before high-risk corneal transplantation. For this purpose, corneal crosslinking (CXL) will be used, which has been shown to potently regress corneal blood and lymphatic vessels. Prior to transplantation, patients will be randomized into 2 groups: (1) CXL (intervention) or (2) no pretreatment (control). CXL will be repeated once if insufficient reduction of corneal neovascularization should be observed. All patients (both groups) will then undergo corneal transplantation. In the intervention group, remaining blood vessels will be additionally regressed using fine needle diathermy (on the day of transplantation). Afterwards, the incidence of graft rejection episodes will be evaluated for 24 months (primary endpoint). Overall graft survival, as well as regression of corneal vessels and/or recurrence, among other factors, will be analyzed (secondary endpoints). Discussion: Based on preclinical and early pilot clinical evidence, we want to test the novel concept of temporary (lymph)angioregressive pretreatment of high-risk eyes by CXL to promote subsequent corneal graft survival. So far, there is no evidence-based approach to reliably improve graft survival in the high-risk corneal transplantation setting available in clinical routine. If successful, this approach will be the first to promote graft survival in high-risk transplants. It will significantly improve vision and quality of life in patients suffering from corneal blindness. Trial registration ClinicalTrials.gov NCT05870566. Registered on 22 May 2023.

Item Type:	Article
Creators:	Creators Email ORCID ORCID Put Code Wiedemann, Johanna UNSPECIFIED https://orcid.org/0009-0000-0496-4921 UNSPECIFIED Hos, Deniz UNSPECIFIED UNSPECIFIED UNSPECIFIED Limburg, Endrik UNSPECIFIED UNSPECIFIED UNSPECIFIED Zettelmeyer, Ulrike UNSPECIFIED https://orcid.org/0000-0003-1406-8164 UNSPECIFIED Schiller, Petra UNSPECIFIED https://orcid.org/0000-0002-9957-1465 UNSPECIFIED Franklin, Jeremy UNSPECIFIED https://orcid.org/0000-0003-1536-0925 UNSPECIFIED Bachmann, Björn UNSPECIFIED https://orcid.org/0000-0002-3974-7609 UNSPECIFIED Böhringer, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Dietrich-Ntoukas, Tina UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchsluger, Thomas A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Geerling, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Lang, Stefan J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mayer, Wolfgang Johann UNSPECIFIED UNSPECIFIED UNSPECIFIED Priglinger, Siegfried UNSPECIFIED UNSPECIFIED UNSPECIFIED Reinhard, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Seitz, Berthold UNSPECIFIED UNSPECIFIED UNSPECIFIED Cursiefen, Claus UNSPECIFIED https://orcid.org/0000-0002-1958-411X UNSPECIFIED
URN:	urn:nbn:de:hbz:38-815182
Identification Number:	10.1186/s13063-024-08011-1
Journal or Publication Title:	Trials
Volume:	25
Number:	1
Page Range:	pp. 1-15
Number of Pages:	15
Date:	6 March 2024
Publisher:	Springer Nature
ISSN:	1745-6215
Language:	English
Faculty:	Faculty of Medicine
Divisions:	Faculty of Medicine > Augenheilkunde > Klinik und Poliklinik für Allgemeine Augenheilkunde Faculty of Medicine > Medizinische Statistik und Bioinformatik > Institut für Medizinische Statistik und Bioinformatik � IMSB Faculty of Medicine > Weitere > Zentrum für Klinische Studien
Subjects:	Medical sciences Medicine
Uncontrolled Keywords:	Keywords Language Cornea ; (Lymph)angioregressive preconditioning ; Multicenter randomized clinical trial (RCT) ; Corneal transplantation, Crosslinking (CXL) ; Graft rejection ; Neovascularization ; High‑risk corneal transplantation ; Randomized controlled trial English
['eprint_fieldname_oa_funders' not defined]:	Publikationsfonds UzK
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/81518