Clinical outcomes in a large multi‐Centre prospective corneal transplant study

Abstract

AbstractThe output from Work package 2 (WP2) of the VISICORT project included four deliverables: Establishment of secure multi‐site clinical database of human corneal transplant recipients. Report of 1‐year outcomes from multi‐site prospective biological sampling and clinical follow‐up of full thickness (FT)‐ and posterior lamellar (PL)‐CT recipients Report of 3‐year prospective outcomes of FT‐ and PL‐CT recipients Report of clinical factors associated with adverse immunological outcomes from FT‐ and PL‐CT within the overall transplant practice of a network of 5 leading EU centres. In more general terms, the main mission of WP2 was to develop a cloud‐based system to collect relevant, well‐defined clinical information and track biological samples, to recruit patients from the five clinical centers, to collect biological samples and clinical data and to follow these patients clinically over several years.The current speech focus on the clinical outcomes 928 prospectively enrolled patients followed up to 3 years.Beyond confirming known factors associated with an adverse immunological outcome after FT‐ and PL‐CT such as the influence of primary diagnosis and type of surgery as risk factors, the clinical factors study revealed factors which needs to be explored further on. Identification of a re‐bubbling procedure (repeated injection of air to keep a PL graft in place) as an important risk factor for development of a later acute rejection episode is important as re‐bubbling is necessary in a fair large number of CT‐PL procedures (15–25%). The finding that presence of loose sutures after CT‐FT is a significant risk factor for AGR is not surprising, but further confirms that patients undergoing CT‐FT needs to be followed closely.Concerning graft failure, it is worth to note that presence of diabetes 2 was identified as a significant risk factor for graft failure after CT‐FT. This may be due to a partially neurotrophic disease state in many patients with diabetes 2 and this has to be taken into account when deciding to perform CT‐FT and in the clinical follow‐up, which need to be meticulous.The current clinical variables study is unique, and it would seem compelling to continue the clinical follow‐up of the recruited patients beyond the funding period for VISICORT. This would of course require new grant applications and obtaining new ethical approvals from the ethics committees at the five clinical centres.