A major task within the VISICORT project entails three multi-centre clinical studies to analyze bio-samples from more than 700 human subjects. This important aspect of VISICORT is being coordinated by Prof Dr Jesper Hjörtdal at the Aarhus University Hospital NBG in Denmark.
A multi-centre, “cross-sectional” clinical analysis study involves people (goal: 420 participants) with existing corneal transplants (CT) and healthy adult volunteers. Secondly, a multi-centre “prospective study” involves people who are new recipients of corneas (goal: 300 participants). In both studies, the participants are divided into groups in order to draw comparisons and draw inferences. The groups involved in these two studies include people with corneal transplant/s and healthy adult volunteers who are at the ophthalmology clinic for a check-up. The study subjects will be monitored, or “followed” for 3 years or more where repeat bio-samples, including blood and tears, are drawn periodically. Anyone willing, who can give informed consent and falls into one of the designated categories is able to take part in the study. Results of comprehensive ophthalmic examinations, corneal thickness measurements, and endothelial cell density tests will be stored in a secure clinical database system. These large studies aim to discover a biomarker present in the bio-samples which will help clinicians identify people who are at high risk for corneal transplant rejection episodes.
A third, multi-centre “clinical variables” study is also part of the VISICORT research plan. Here, people who have had a corneal transplant will be followed for a 3-year period where bio-samples will be collected and analyzed. Clinicians will be gaining knowledge regarding adverse immune outcomes from CT procedures in order to help validate and field test biomarker-based surveillance strategies. A highly detailed clinical follow-up will be available for the participants involved. A broad survey of clinical variables, immunosuppression practices, any complications and graft outcomes will be included.
Best practice standard care will be followed at each of the 5 clinical sites: Aarhus University Hospital (Denmark), Charité Universitätsmedizin Berlin (Germany), Royal Victoria Eye and Ear Hospital (Dublin, Republic of Ireland), Bristol Eye Hospital (U.K.) and the University Hospital Center (CHU) of Nantes (France).
At the moment, our recruitment targets are nearly achieved. In the cross-sectional clinical analysis study, we have collected bio-samples from 413 participants. We are nearly at our goal! For the multi-centre prospective study, 332 participants are involved. This exceeds our target. Finally, our clinical variable study has 562 people enrolled currently.*
*These figures were last updated on 8 November 2018.