Corneal donation for research versus for transplantation: A-year prospective study of acceptance rates in a French University Hospital

Abstract

Fresh corneal donation is essential for basic and preclinical research, but more unknown to public and the medical teams than donation for transplantation: it may raise concerns. We prospectively compared the acceptance rates and the characteristics of targeted corneal donation for research versus donation for transplantation during one year. The Agence de la Biomé decine authorized us to procure fresh corneas targeted for research, only from the donors with medical contraindications for transplantation, in order not to increase grafts shortage. Three nurses from the hospital coordination team of Saint-Etienne University Hospital, obtained consent for research and transplantation in parallel, screening all intra-hospital deaths cases, following standard protocol to check no refusal from families, despite the French opt-out system. They contacted 127 families for research and 244 for transplantation, in 71% of cases by telephone. Consent was obtained in 62% of cases for research and 54% for transplantation (P = 0.135). The main contraindication for transplantation was the cognitive disorders (66%) followed by the blood cancers (8%). This new specific activity, providing new source of fresh corneas for research immediately usable without any eyebank storage steps, didn't reduce the number of corneas procured for transplantation versus previous years (P = 0.998). Donors in the research group were 10 years older (P<0.001) without difference regarding endothelial cell quality (P = 0.071), allowing maximal clinical relevance for protocols using these fresh human scientific corneas provided by targeted donation.

Human Whole-Eye Donation for Research—Optimizing Clinical Trial Informed Consent

“…Notably, researchers in France concluded that targeting for research consent did not have a negative impact on clinical donations; thereby, research and clinical donation can potentially be an avoided competition. 10 Below is a summary of the current whole globe for research sourcing framework in the US.…”

“…Importantly, the longitudinal research consent approach provides globe access in the research arena before and after death, noting that some of these globes could never be destined for clinical use due to the prior involvement of an investigational device/surgical intervention. Notably, researchers in France concluded that targeting for research consent did not have a negative impact on clinical donations; thereby, research and clinical donation can potentially be an avoided competition . Below is a summary of the current whole globe for research sourcing framework in the US.…”

“…When the current research study involves eye surgery, the ICF should inform research participants that if the surgery disqualifies them to be cornea donors for clinical transplant, there remains an opportunity for research donation after death. If there is the opportunity for a choice between a clinical and research donation, the ICF can present the benefits of the research donation and the lack of a negative impact on patients in need of clinical transplant …”

“…If there is the opportunity for a choice between a clinical and research donation, the ICF can present the benefits of the research donation and the lack of a negative impact on patients in need of clinical transplant. 10 • The ICF should be clear about which eyes are being considered for this specific research donation process. If both eyes have an implant, then both could be considered for analysis after death.…”

Corneal supply and the use of technology to reduce its demand: A review

“…In this aspect, there is a frequent desire to collect other tissue types, such as retina, or donors with a particular characteristic including age, sex and type of disease or disease stage 37 . In an ideal world, procurement of research tissues would be collected specifically as ‘tissue for research purposes’ rather than a tissue collected for transplantation but then relegated to research due to safety or quality concerns 38 . The volume or availability of tissue required for timely completion of a research project may also go above and beyond the capabilities of what an eye bank can meaningfully supply without leading to delays 13 …”