Descemet membrane endothelial keratoplasty (DMEK): clinical results of precut versus surgeon-cut grafts.

PURPOSE: This study aims to investigate possible differences in clinical outcomes between precut and surgeon-cut grafts for Descemet membrane endothelial keratoplasty (DMEK). METHODS: 142 consecutive patients who underwent DMEK were included in the study. 44 patients received precut tissues, and 98 patients received surgeon-cut tissues. Precut grafts were allocated to the patient by the German Society for Tissue Transplantation if available. We compared the outcomes of both groups for changes in visual acuity, central corneal thickness, endothelial cell density, re-bubbling rate, and graft failure rate. RESULTS: Patients who received precut tissues experienced similar increase in visual acuity (median change 0.4 logMAR) and decrease of corneal swelling (median change 132 µm) compared with those who received surgeon-cut tissues (median VA change 0.3 logMAR, p = 0.55, CCT change 118 µm, p = 0.63). There was no statistical difference in endothelial cell density (1436 vs. 1569 cells/mm2, p = 0.37), re-bubbling (32% vs. 35%, p = 0.85), and graft failure rate (5% vs. 1%, p = 0.23). No primary graft failure occurred in the group of precut grafts. CONCLUSION: Both methods lead to comparable results for visual acuity, corneal deswelling, endothelial cell density, and re-bubbling rate. A previously described higher graft failure rate for precut tissues could not be confirmed in our study. Thus, we do not see medical reasons against the use of precut tissues. There are several advantages of precut DMEK tissues over surgeon-cut tissues, especially the prevention of graft loss during preparation in the operating theater.

Cornea Procurement and Processing up to 72 Hours: No Risk for Cornea Transplant Quality.

BACKGROUND: The realization of tissue donations is bound to a tight timeframe. Depending on the type of tissue, time limits are specified within which the donation must be procured and processed. Otherwise, there is a risk of tissue quality loss with increasing time intervals from cardiovascular arrest. According to the European Directorate for the Quality of Medicines and HealthCare (EDQM) guide, cornea must be procured and processed within 72 h after death. The question arises whether this time interval has an influence on the quality of transplanted tissues and how it affects the accomplishment of tissue donations. METHODS: In order to obtain information on this, the numbers of tissue donations in the network of the German Society for Tissue Transplantation (DGFG) were evaluated as a function of the death to retrieval time (DRT) as well as the death to preservation time (DPT). For this purpose, 21,454 database entries of cornea donations made in the period from 2014 to 2018 were included. RESULTS: The results show that nearly 50% of donations realized in the DGFG network could be processed only 48 h or later after cardiovascular death due to the opt-in regulation in Germany. For these donations, there seems to be a higher discard rate compared to donations taken earlier. Nevertheless, there is a transplantation rate for these grafts of more than 65%, which is comparable to average transplantation rates stated in the literature. CONCLUSION: All corneas finally selected for transplantation must meet the specified quality parameters. Since this naturally also applies to transplants that could only be procured at later time points, it can be concluded that DPT up to 72 h for corneal tissue is adequate and has no influence on the quality of corneas that are ultimately transplanted.

Cornea donation in Germany: Obtaining consent.

Tissue donation is important to reverse cornea-related blindness. Unfortunately, the willingness to make a decision concerning organ and tissue donation while still alive remains low despite all efforts. By analyzing anonymized archived data from 25 654 next-of-kin interviews from our database over a period of 5 years (2013-2018), it was found that only 20.8% of all potential cornea donors have declared their own wishes. While still alive, refusal was communicated more often than consent by potential donors. Overall consent rates were 39.2%, with parents and siblings consenting more often than other relatives and females refusing more often than male family members. Personal interviews and interviews via telephone handled by staff known to the family resulted in better consent rates (up to 75.6%) with male interviewers receiving higher consent rates in general. The gender of the approached relatives in relation to a male/female interviewer was of low importance. The results also show that it is important to allow discussion about that topic between family members-the more relatives that were involved the higher the probability of consent.

Comparison of preloaded grafts for Descemet membrane endothelial keratoplasty (DMEK) in a novel preloaded transport cartridge compared to conventional precut grafts.

To determine the safety and graft quality of eye bank precut and preloaded grafts for Descemet membrane endothelial keratoplasty (DMEK) after storage and shipping in a novel preloaded transport cartridge compared to precut grafts in a conventional viewing chamber. In this laboratory proof-of-concept study, 29 human donor corneas that were unsuitable for transplantation with a mean endothelial cell density of 1948 ± 260 cells/mm2 were prepared using liquid bubble technique for producing precut lamellar grafts. The grafts were either preloaded into novel transport cartridge (n = 16) or transferred into conventional Krolman viewing chamber (control, n = 13). Grafts were stored for 24 or 48 h in dextran-containing medium at room temperature and subjected to a shipping simulation. Endothelial cell loss (ECL) and morphology were determined at different steps. Endothelial cell viability staining was performed with calcein dye. Mean ECL in the preloaded transport cartridge was 0.7% ± 1.2% after 24 h and 3.4% ± 1.2% (p = 0.006) after 48 h storage and injection. In the control group the ECL was mean 1.6% ± 2.7% after 24 h compared to 3.7% ± 0.9% (p = 0.042) after 48 h. The slightly higher endothelial cell loss in the viewing chamber group after 48 h was not statistically significant compared to the preloaded transport cartridge (p = 0.8). Calcein staining was comparably low in all groups and correlated with the low ECL in both groups. DMEK grafts can be preloaded into a novel transport cartridge using a "no touch" technique, stored and shipped for up to 2 days in dextran-containing medium without significant ECL.

Repeated Freezing Procedures Preserve Structural and Functional Properties of Amniotic Membrane for Application in Ophthalmology.

For decades, the unique regenerative properties of the human amniotic membrane (hAM) have been successfully utilized in ophthalmology. As a directly applied biomaterial, the hAM should be available in a ready to use manner in clinical settings. However, an extended period of time is obligatory for performing quality and safety tests. Hence, the low temperature storage of the hAM is a virtually inevitable step in the chain from donor retrieval to patient application. At the same time, the impact of subzero temperatures carries an increased risk of irreversible alterations of the structure and composition of biological objects. In the present study, we performed a comprehensive analysis of the hAM as a medicinal product; this is intended for a novel strategy of application in ophthalmology requiring a GMP production protocol including double freezing-thawing cycles. We compared clinically relevant parameters, such as levels of growth factors and extracellular matrix proteins content, morphology, ultrastructure and mechanical properties, before and after one and two freezing cycles. It was found that epidermal growth factor (EGF), transforming growth factor beta 1 (TGF-ß1), hepatocyte growth factor (HGF), basic fibroblast growth factor (bFGF), hyaluronic acid, and laminin could be detected in all studied conditions without significant differences. Additionally, histological and ultrastructure analysis, as well as transparency and mechanical tests, demonstrated that properties of the hAM required to support therapeutic efficacy in ophthalmology are not impaired by dual freezing.

Streptobacillus notomytis sp. nov., isolated from a spinifex hopping mouse (Notomys alexis Thomas, 1922), and emended description of Streptobacillus Levaditi et al. 1925, Eisenberg et al. 2015 emend.

A pleomorphic, Gram-negative, rod-shaped, indole-, oxidase- and catalase-negative, non-spore-forming, non-motile bacterium was isolated in 1979 from the heart of a spinifex hopping mouse (Notomys alexis Thomas, 1922) with septicaemia and stored as Streptobacillus moniliformis in the strain collection of the Animal Health Laboratory, South Perth, Western Australia (AHL 370-1), as well as under CCUG 12425. On the basis of 16SrRNA gene sequence analyses, the strain was assigned to the genus Streptobacillus, with 99.4 % sequence similarity to the type strain of Streptobacillus moniliformis, 95.6 %sequence similarity to the type strain of Streptobacillus hongkongensis and 99.0 %sequence similarity to the type strain of Streptobacillus felis. The clear differentiation of strain AHL 370-1T from Streptobacillus moniliformis, Streptobacillus hongkongensis and Streptobacillus felis was also supported by rpoB, groEL and recA nucleotide and amino acid sequence analysis. Average nucleotide identity was 87.16 % between strain AHL 370-1T and Streptobacillus moniliformis DSM 12112T. Physiological data confirmed the allocation of strain AHL 370-1T to the family Leptotrichiaceae, considering the very similar profiles of enzyme activities and fatty acids compared to closely related species. Within the genus Streptobacillus,isolate AHL 370-1T could also be separated unambiguously from the type strains of Streptobacillus moniliformis, Streptobacillus hongkongensis and Streptobacillus felis by MALDI-TOF mass spectrometry. Two further strains (KWG2 and KWG24) isolated from asymptomatic black rats in Japan were highly similar to AHL 370-1T. On the basis of these data, we propose the novel species Streptobacillus notomytis sp. nov., with the type strain AHL370-1T (=CCUG 12425T=DSM 100026T=CCM 8593T=EF 12425T).

Multipotent stromal cells derived from common marmoset Callithrix jacchus within alginate 3D environment: Effect of cryopreservation procedures.

Multipotent stromal cells derived from the common marmoset monkey Callithrix jacchus (cjMSCs) possess high phylogenetic similarity to humans, with a great potential for preclinical studies in the field of regenerative medicine. Safe and effective long-term storage of cells is of great significance to clinical and research applications. Encapsulation of such cell types within alginate beads that can mimic an extra-cellular matrix and provide a supportive environment for cells during cryopreservation, has several advantages over freezing of cells in suspension. In this study we have analysed the effect of dimethyl sulfoxide (Me2SO, 2.5-10%, v/v) and pre-freeze loading time of alginate encapsulated cjMSCs in Me2SO (0-45 min) on the viability and metabolic activity of the cells after freezing using a slow cooling rate (-1°C/min). It was found that these parameters affect the stability and homogeneity of alginate beads after thawing. Moreover, the cjMSCs can be frozen in alginate beads with lower Me2SO concentration of 7.5% after 30 min of loading, while retaining high cryopreservation outcome. We demonstrated the maximum viability, membrane integrity and metabolic activity of the cells under optimized, less cytotoxic conditions. The results of this study are another step forward towards the application of cryopreservation for the long-term storage and subsequent applications of transplants in cell-based therapies.

Expert Revision of Key Elements for Clinical-Grade Production and Qualification of Perinatal Derivatives.

Perinatal derivatives have been proposed as adjunct therapeutic strategies or innovative treatments. Undoubtedly, perinatal derivatives can offer the opportunity and source material to isolate multipotent stem cells, but both maternal- and fetal-derived tissues can be processed and transformed into engineered tissues or advanced biomedical devices, whose potential remains to be fully elucidated. Promising preclinical and clinical results collected so far clearly foresee an escalation of such novel treatments. Market forecasts predict exponential growth in such advanced medicinal products during the next decade, with a pragmatic innovation for medicine into a more advanced biomedical version, enlarging the portfolio for treating a wide range of congenital and acute conditions. However, all these promising and fascinating therapeutic possibilities cannot gain a solid and recognized role in established medical practice without rigid and harmonized manufacturing strategies. The implementation of strategies according to guidelines and directives compiled by Regulatory Agencies, in conformity to (European) Pharmacopoeia and for Good Manufacturing Practice -conforming production of such products, represent critical steps required to translate perinatal technologies into effective therapeutic approaches. During the past 5 years, a panel of European experts and developers, gathered under the umbrella of the COST Sprint Action, supported by the European Cooperation in Science and Technology action, had the opportunity to revise and summarize experience and recommendations for a fruitful and proficient generation of perinatal biomedical products. In order to facilitate the creation and potential commercialization of perinatal bioengineered and advanced pharmaceutical products and technologies, such a collection of data and recommendations is described and discussed here.

P04-A115†Serum containing organ culture of the human cornea - still state of the art?

PURPOSE: For decades, human corneas are prepared and stored in specialized tissue banks prior to transplantation. Especially in Europe, storage takes place in 'organ culture', the storage in cell culture medium at approximately physiological temperature. Traditionally, a serum-containing medium is used for this purpose. However, the use of fetal calf serum has considerable disadvantages: there is a risk of disease transmission, availability may not always be guaranteed in the necessary quality, there are considerable differences from batch to batch, which is associated with batch testing required in each case, and last but not least, the extraction of serum from unborn calves is an ethical issue. METHODS: In recent years, several studies have focused on the improvement of organ culture conditions for donor corneas, including different serum-free media and alternative deswelling substances. Meanwhile, media are on the market which seem to be equivalent to serum-supplemented MEM. Nevertheless, serum-free medium has not yet found its way into routine organ culture of corneas. RESULTS: Our own preliminary studies have shown that despite the promising approaches, no satisfactory overall result could be achieved. Since only maintenance metabolism is required for storage of corneas until transplantation, in principle cultivation in the conventionally used medium seems possible without addition of serum at all. Corneas stored in this way had comparably endothelial cell density (ECD) to their counterpart stored in serum-supplemented medium. However, during the final evaluation after deswelling, the ECD dropped drastically.Engelmann et al. started research on the use of serum-free culture medium (SFM) for a long time and comparable or even superior ECD and viability could be demonstrated. So far, however, it has not been possible to define a deswelling medium adapted to these conditions.Also, a serum-free storage medium developed by Eurobio (CorneaSyn) could not completely convince, because although ECD of the examined corneas remained constant, the morphology of the cells changed. CONCLUSION: Since it is essential to intensify efforts towards a serum-free system it is planned to test serum substitutes and, if possible, also to replace the de-swelling additive dextran with a less harmful alternative to guarantee the quality of cornea grafts in the future.

Preparation of human amniotic membrane for transplantation in different application areas.

The human amniotic membrane (hAM) is the inner layer of the placenta and plays protective and nutritional roles for the fetus during pregnancy. It contains multiple growth factors and proteins that mediate unique regenerative properties and enhance wound healing in tissue regeneration. Due to these characteristics hAM has been successfully utilized in ophthalmology for many decades. This material has also found application in a variety of additional therapeutic areas. Particularly noteworthy are the extraordinary effects in the healing of chronic wounds and in the treatment of burns. But hAM has also been used successfully in gynecology, oral medicine, and plastic surgery and as a scaffold for in vitro cell culture approaches. This review aims to summarize the different graft preparation, preservation and storage techniques that are used and to present advantages and disadvantages of these methods. It shows the characteristics of the hAM according to the processing and storage methods used. The paper provides an overview of the currently mainly used application areas and raises new application possibilities. In addition, further preparation types like extracts, homogenates, and the resulting treatment alternatives are described.

P24-A114†Bringing together the eye banking community throughout Europe and beyond - promoting eye donation in Africa.

PURPOSE: It is estimated that globally there are more than 12.7 million corneal blinds with the vast majority of those living in the developing world. There is huge demand for corneal transplants worldwide as currently only one out of 70 patients can be provided with a cornea.Following the spirit of EEBA in bringing together the international eye banking community we present on our efforts and vision in contributing to the elimination of avoidable blindness in Africa by promoting sustainable eye donation programs. METHODS: At the congress of the South African Tissue Bank Association (SATiBA) in November 2022 a dedicated Round Table Discussion takes place on eye donation in Africa, organized by the World Union of Tissue Banking Associations (WUTBA) together with the Global Alliance of Eye Bank Associations (GAEBA), SATiBA and the German Society for Tissue Transplantation (DGFG). Individuals, national and global players in tissue medicine meet aiming to promote and advocate corneal donation in sub-Saharan Africa to establish patient care that is self-sustaining from within the countries.In preparation for the meeting a questionnaire was completed by the participants to understand the current situation in individual countries: Responses by ophthalmologists, tissue bankers, awareness and tissue donation coordinators from Kenya, Uganda, Nigeria, Ethiopia, and South Africa were evaluated. RESULTS: The survey revealed that all countries are establishing national health acts with references to tissue donation or have them in place with regulations still to be detailed. These are fundamental to strengthen confidence in tissue donation and to start developing donation infrastructures. In all countries there is doubt about donation after death showing the need for advocacy towards the public.The aim of the Round Table is creating a momentum of networking and sharing experience to support the African countries in building local infrastructures and becoming independent from tissue imports in the future. CONCLUSION: What frameworks must exist to successfully establish donation programs in Africa? What help can be provided by countries and organizations that have stable donation programs? These and other questions will be attempted at the Round Table. Bringing together experts, bundling synergies, and creating a momentum to promote cornea donation on social, political, and community level will be a step towards the vision of creating a world in which nobody is needlessly visually impaired.

P25-A123†Indo - German GIZ collaboration - impact and way forward in global eye banking.

PURPOSE: Geographical imbalance in cornea supply is a key feature of global eye banking. Most countries of South Asia particularly India suffer from donor cornea shortage which limits the number of keratoplasties, thereby aggravating the already high burden of removable blindness. The purpose of the project is to identify and cross-pollinate best practices from two leading eye banking institutions in India and Germany, and thereby improve service delivery of both systems. The project is supported by the GIZ Hospital Partnerships funding program on behalf of the Federal Ministry for Economic Cooperation and Development (BMZ) with a co-financing by the Else Kröner-Fresenius Foundation (EKFS). It started in 2021 and will last upto 2023. METHODS: A joint expert group from both organisations conducted a series of workshops to identify the areas of intervention and specific practices to be introduced at the Indian partner's region. The overall increase in cornea collections and transplants, documented systemic improvement measures and research output were defined as the key outcomes. RESULTS: Interim results are presented here. Two interventions identified were expansion of catchment area of cornea collection in India, and improved information management system to monitor the progress and efficiency of the collection centres. Under the former intervention, the hub-and-spoke model from the German partner was introduced to the most populous state of India through establishment of two new cornea collection centres (spokes) for Hospital based Cornea collections. In six months these centres have supplied 79 donor corneas leading to 63 transplants at the hub. Under the latter intervention, the specifications of a baseline data capture and operations management system which can be used in low resource settings are being developed. CONCLUSION: The initiative has shown how best practice from one geography can be adapted and successfully implemented in another geography , Furthermore, the public knowledge resources created in the project can be used by other eye banks to advance eye banking in their respective countries.

Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings.

Perinatal derivatives (PnD) are drawing growing interest among the scientific community as an unrestricted source of multipotent stem cells, secretome, and biological matrices. They are useful for the treatment of diseases that currently have limited or no effective therapeutic options, but they require the development of regenerative approaches. With this development, the question of regulation of donation, processing, and distribution has therefore become more important. Within the European Cooperation in Science and Technology (COST) community, we compiled a group of international experts on PnD technologies, who revised and compared existing EU national regulations. Notably, despite clear European directives, each EU Country has developed their own implementation and standard levels for cell- and tissue-based therapies. To enable extended applications of PnD treatments within the EU community and worldwide, harmonization is highly recommended. This paper aims to provide an overview of the various options available to introduce PnD into clinical practice. For this purpose, the different aspects resulting from (1) the type of PnD, (2) the amount of available data, (3) the degree of manipulation, and (4) the intended application and the process toward a possible commercialization will be presented. In the future, it will be important to find a balance between regulatory requirements and the best medical quality of the PnD product.

Video analysis of osmotic cell response during cryopreservation.

Cellular response during the freeze-thaw process strongly affects the cryopreservation outcome including cell morphology and cell viability. Cryomicroscopy was used to individually analyze the osmotic response of human pulmonary microvascular endothelial cells (HPMECs) during slow cooling (1 °C/min) to -60 °C and fast rewarming to 4 °C (100 °C/min). The ice nucleation temperature was controlled (T(n)=-8 °C). Different concentrations of different cryoprotectant agents, dimethyl sulfoxide, ethylene glycol, proline, ectoin, and trehalose resulted in various cell volume changes. The described methods for image processing and computer vision allows for a fully automatic and individual analysis of the osmotically driven cell response under a temporal resolution of 2 frames per second. As a result, we show that in the presence of dimethyl sulfoxide or ethylene glycol cells shrink during cooling to a high degree, especially at intermediate molar concentrations in the range between 0 and 2M, while during rewarming cells swell to isotonic volumes gradually. Comparative cell vitality tests, membrane integrity, and viability tests after 24h recultivation, under these conditions show a high cell survival. In the absence of cryoprotective agents or with proline, ectoin or trehalose, osmotic shrinkage did not meet our expectations: a freeze-induced swelling was detected during cooling and an extreme swelling was observed after rewarming, which was accompanied by lower comparative cell viability. A linear correlation between the cellular membrane integrity after cryopreservation and the maximal relative cell volume was derived (R(2)=96). The results clearly show that it is crucial to analyze cells within a sample individually due to their individual different osmotic response.

Compatible solutes improve cryopreservation of human endothelial cells.

Dimethyl sulfoxide (DMSO) is till now a widely used cryoprotective agent for cryopreservation of cells. Since high concentrations of DMSO have detrimental effects on cell functioning the aim of this study is to reduce the DMSO concentration by using compatible solutes (CS). These are small organic osmolytes that microorganisms synthesize and accumulate to counteract stress factors. Three CS, hydroxyectoine, ectoine and L-proline were investigated as cryoprotective agents for the cryopreservation of the human endothelial cell line HPMEC-ST1.6R. They were either supplemented to freezing or to cell culture medium. L-proline was the most effective CS, the efficiency of recultivation was improved by more than 100 percent. A combination of L-proline and ectoine in the cell culture medium resulted in an improvement by 63 percent. Our results show that L-proline and ectoine could be used as additional CPAs to improve the cryopreservation of human endothelial cells in the presence of low DMSO concentration.

8†The donor of tomorrow: challenges posed by the pandemic, demographic change, and increased transplant requirements.

In the Corona pandemic, the importance of donor health for the supply of patients with high-quality transplants has once again become particularly apparent in the field of cornea donation.And there are further challenges ahead: Due to new operation methods such as lamellar techniques an earlier stage of disease can be treated hence patients are being operated at younger ages. At the same time, with demographic change, potential donors are getting older.Therefore, the demand for a high-quality transplant without pre-operations seems to be difficult to fulfil in the future. This is particularly important in the highly developed industrialised countries, where the indications for corneal transplantation are different and the expected quality characteristics are therefore other than in emerging or developing countries, for example. At the same time, the new surgical methods present the tissue banks with new tasks to meet the surgeons' demands.In the DGFG network, the average age of corneal donors is currently 69.7 years while the requests for transplants with a high endothelial cell density (ECD) increase. The ECD continues to be one of the main criteria for a high-quality cornea and is more likely to be found in younger donors. As mentioned at the beginning, however, the average life expectancy in Germany is already currently around 80 years.It seems that it is impossible to find the perfect donor of tomorrow. With the increase in the need for high-quality transplants, the question must be asked whether donor shortage is a home-grown problem in industrialised countries. What developments need to be initiated to counter the trend towards donor shortage? Could greater flexibility at the medical and/or regulatory level be a solution? The presentation aims to shed light on these and other questions and would like to discuss this with the experts.

1†Crisis becomes the norm: how a non-profit network withstands the pandemic.

SARS-CoV-2 (corona virus) presents the world with new kinds of challenges. The crisis mode that persisted in many countries also put a strain on the German health system: on the one hand, through the treatment of patients infected with corona, and on the other hand through the cancellation and postponement of elective operations. This had a corresponding impact on tissue donation and transplantation. The effects of the pandemic-related restrictions can be reflected by the rate of corneal donation in the DGFG network: With the beginning of the first closure in Germany, donation and transplant numbers decreased by almost 25% from March to April 2020. After a recovery during summer, the activities were again restricted from October onwards due to increasing infection numbers. Subsequently in 2021 there was a similar trend.The already careful screening of potential tissue donors was expanded in accordance with the guidelines of the Paul-Ehrlich-Institute. However, this important measure led to an increase in discontinued donations due to medical contraindications from 44% in 2019 to 52% in 2020 and 55% in 2021 (Status Nov 2021). Nevertheless, the donation and transplantation result from 2019 was exceeded and DGFG was able to maintain patient care in Germany on stable level compared to other European countries. This positive result is partly due to an increased consent rate of 41% in 2020 and 42% in 2021 due to a higher sensitivity in the population to health issues during the pandemic. In 2021, the situation stabilised again, although the number of donations that could not be realised due to corona detection in the deceased continued to increase with the waves of infections that occurred.Low losses in donation and thus in the supply of transplants for patients seem to be due to the fact that a nationwide network such as the DGFG can respond flexibly to changing requirements. For example, if the number of COVID-19 infections varies between regions, it is possible to react to the local conditions to continue donation and processing where possible and allow allocation to regions where transplantation can take place.In summary it has been shown that efficient donation programs, resilient network structures, awareness of population for tissue donation and effective precautionary measures ensure a safe patient care with corneal transplants also in pandemic times.

11†Growing together in diversity - Indo-German cooperation enhancing eye donation in North India.

In India, the most densely populated state is Uttar Pradesh in the Northern region. This state has a huge base of corneal blind population due to cornea infections, ocular trauma, and (chemical) burns.Successful cornea transplantation using human post-mortem donated cornea is a treatment modality. In India lack of availability of donated cornea is a public health challenge. Thus, there is great need to reduce the huge demand and supply gap by increasing the donations for supply of cornea to patients.The Eye Bank at the Dr. Shroff's Charity Eye Hospital (SCEH) and the German Society for Tissue Transplantation (DGFG) collaborate in a project to enhance cornea donation and eye bank's infrastructure in Delhi. The project is supported by the Hospital Partnerships funding programme which is a joint initiative of Germany's Federal Ministry for Economic Cooperation and Development (BMZ) and the Else Kröner-Fresenius Foundation (EKFS) and carried out by the German Society for International Collaboration (GIZ GmbH).The project aims to increase the number of cornea donations by the SCEH eye bank through establishing two new eye collection centers where donation is coordinated and that are integrated into the existing and well-established eye bank and donation infrastructure of SCEH. Further, data management of the eye bank will be improved by developing a concept for an electronic database system that allows faster monitoring and evaluation of the processes. All activities are carried out according to a defined project plan. The basis of the project is an open-minded analysis and understanding of processes of both partners in relation to the respective legislations plus the environment and conditions in both countries.Aside from intercultural exchange and personal contacts both partners benefit from mutual on-site visits and exchanging best practices in eye donation and banking as well as sharing expertise in research topics.This project is a great example on how strong and sustainable relationships can be build across the globe improving the infrastructure for cornea donations to help corneal blind patients.

New Safety Aspects in Corneal Donation-Studies on SARS-CoV-2-Positive Corneal Donors.

In the tissue donation field, to prevent pathogen transmission, all donors are screened by postmortem swabs for SARS-CoV-2 using qRT-PCR. Corneas from donors who tested positive for SARS-CoV-2 were subjected to further investigations. Corneal transplants and culture medium from positive donors were cultured under appropriate safety conditions for further analyses. Cornea tissue samples, including sclera/limbus/cornea, and culture media were taken at different time points for testing for SARS-CoV-2 using qRT-PCR, immunohistochemistry (IHC) and subgenomic RNA (sgRNA) analysis. Between January and May 2021, in four donors with initial negative premortem rapid tests, SARS-CoV-2 was detected post-mortem using qRT-PCR. In these cases, SARS-CoV-2 was observed at the beginning of cultivation in both tissue and culture medium using qRT-PCR and IHC. The virus was mainly localized in the limbus epithelial cells, with a stable detection level. Premortem rapid tests are potentially insufficient to exclude SARS-CoV-2 infection in corneal donors. While, for SARS-CoV-2, the risk of infection via transplants is considered low, a residual risk remains for presymptomatic new infections. However, our investigations provide the first indications that, with organ cultures, the risk of virus transmission is minimized due to the longer minimum culture period.