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Objectives To evaluate microbiological culture rate and positivity of corneoscleral rim and cornea storage media as well as possible risk factors for contamination with real-world data. Methods Data of consecutive cornea donors implanted in the reference centre from January 2013 to January 2018 were reviewed. Information about cornea characteristics (donor demographic data, endothelial cell density, type of cornea conservation, days of storage, and precut vs full-thickness tissue), and microbiological culture information (corneoscleral rim vs storage sample, positive result) were statistically analysed. Results During the study period, 1369 corneas (737 donors) were implanted. Cultures were performed in 76.8% (n = 1052) of them and were positive in 3.2% of cases, mainly bacteria (84.4%). Corneas preserved in hypothermia represented 61.8% of all positive microbiology results (p < 0.001). Other analysed risk factors did not reach statistically significant association with microbiological positivity. None of the 34 cases with positive microbiological cultures reported ocular infection for the recipients in at least 6 months' follow-up. Conclusions Microbiological tests rate in real-world practice are high despite not being compulsory. Organotypic cultured corneas showed a statistically less positivity in corneoscleral and storage medium than hypothermic ones, resulting in another advantage of this kind of cornea storage. Although precut corneas are thought to present less microbiological positivity, a statistically significant association was not found in the present study.

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.

Objective: Investigate in which eye banks in Brazil the HTLV I and II is used as exclusion criteria for cornea. Nowadays Brazilian Legislation, through Law no 9.434/97 and Ordinance 2600/09 determines that for each donation, laboratory screening tests of high sensibility must be done mandatorily for detection of markers of infectious diseases transmissible by blood: Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HbsAg), Antibody of the Hepatitis B Virus (AntiHBs), Antibody of total Hepatitis B Virus (total Anti- HBc) and Hepatitis C Virus (Anti-HCV), however, paragraph a of Chapter VI, Art. 47 excludes the HTLV as exclusion criteria for cornea donors. Methods: For the realization of this research, information from 35 eye banks was analyzed, through the database of the Transplant Central of Paraiba, evaluated through the Chi-Square Homogeneity Test. Results: It was observed that the positive serology for HTLV I and II was considered exclusion criteria in 18 of the 35 eye banks analyzed. In relation to the geographic analysis of the Eye Banks in Brazil, the ones in the Northeastern and Southern regions were the ones that most considered the HTLV as exclusion criteria. Conclusion: The analyzed Eye Banks did not present difference or significant association between the ones that consider and the ones that do not consider this criterion, showing, this way, that there is not a standardization among the Eye Banks in Brazil.

Defined serological blood tests of deceased cornea donors are required to minimize the risk of viral infections of a transplant recipient as much as possible. Haemolysis, autolysis and bacterial contamination, may produce significant changes of post-mortem blood samples, which may lead to false serological test results. Pre- and post-mortem findings from the same cornea donors of the University Tissue Bank of the Charite in the years 2004–2009 (n = 487) were retrospectively analyzed and compared. The test results from pre-mortem blood samples were defined as the reference for the post-mortem blood test. Of 487 cornea donors, there were a total of 21 cases (4.3 %) with discrepancies between serological test results from pre- and post-mortem blood samples. Of these, 7 values referred to the HBsAg-testing, 3 to the anti-HBs-, 1 to the anti-HBcIgG + IgM-, 1 to the anti-HCV-, 4 to the anti-HIV 1/2- and 5 to the TPLA-findings. False negative results within post-mortem serology occurred in 4 of 487 cases (0.8 %). False positive results within the post-mortem blood samples occurred at a much more frequent rate, with 17 of 487 cases (3.5 %). Discrepancies between serological pre- and post-mortem blood tests occur mainly due to the use of non-validated test systems. Therefore, it seems reasonable to test pre- and post-mortem blood samples serologically, whenever possible, at the same time, regardless of the sample age. Positive results, regardless of the sample type, should always be retested with validated confirmation tests (e.g. NAT), in order to differentiate between false and true positive results.

Background: Corneas needed for keratoplasty can be harvested using two techniques: whole globe enucleation and in situ excision of the corneoscleral disc. This study evaluates the rate of microbial contamination of the donor cornea organ culture medium according to the method of retrieval. Methods: All donor corneas of our cornea bank received between January 1, 2001 and December 31, 2009 put into organ culture and microbiologically tested were prospectively analyzed for microbial contamination of the organ culture medium. Results: 2,805 donor corneas could be included in this study in total. 975 of them were retrieved by whole globe enucleation (group 1) and 1,830 by in situ corneoscleral disc excision (group 2). 15 corneas of group 1 (1.5%) and 46 corneas of group 2 (2.5%) showed a contamination of the organ culture medium. The difference was shown not to be statistically significant (p = 0.082). Conclusion: The rate of microbial contamination in organ-cultured donor corneas does not seem to be dependent on the method of their retrieval.

Aim The purpose of the study was to analyse the number of potential cornea donors in relationship to the number of actual donors. Furthermore, the reasons for the discrepancy between the number of the potential and actual donors were analysed. Methods Over a period of 6 months data were collected from 6 hospitals and the institute for forensic medicine of the university hospital. The reasons why only a few actual donors from a big pool of potential donors remain for transplantation were investigated. Results Circumstances related to the medical staff were causal for refusal in 37 % of the cases. In 23 % the cause for refusal was related to the relatives (23 %). Furthermore, in 16 organisational problems caused a failure in cornea donation. 18 % were excluded due to contraindications. A total rate of 6 % actual donors was achieved. Conclusions The final consent rate was only 6 % out of all potential donors. Organisational failure was only 16 % in contrast to 60 % refusal due to causes relating to medical staff and relatives. Therefore, further education of physicians and the public is needed.

Objetivo: O estudo objetivou desenvolver uma sistemática para a doação intra-hospitalar de córneas visando favorecer o aumento de notificações de potenciais doadores em benefício da sociedade. Método: Trata-se de um relato de experiência cuja metodologia foi realizar o diagnóstico situacional referente ao número de óbitos, notificações e doadores efetivos de córneas, capacitar os colaboradores das áreas críticas para atuarem no processo de doação de córneas, estabelecer fluxograma para notificação e criar indicadores para levantamento, mensuração e análise dos resultados. Resultado: No diagnóstico situacional foi apurada baixa efetivação de notificação e doação de córneas: dos 438 (100%) óbitos, 87 (20 %) foram notificados à OPO, efetivando-se a doação em apenas 14 (16%). Adotou-se como estratégia a implementação de um fluxograma para notificação de potenciais doadores de córneas e capacitação de 76 (39,58 %) profissionais das áreas críticas, com margem de erro após a aula de 3,9 % (30), demonstrando que as dúvidas foram minimizadas por meio do conteúdo exposto. Para mensurar mensalmente o número de óbitos, notificações e doações de córneas foi elaborado um instrumento de Busca Ativa compartilhado com as chefias médicas e de enfermagem envolvidas nesse processo. Conclusão: O estabelecimento do fluxograma interno, o envolvimento e a contribuição efetiva da equipe de enfermagem a partir da capacitação em serviço refletiram-se no aumento do número de notificações, alcançando 275 (86,2%), na queda do número de não-notificações em 49,4% (44) e no aumento da doação de córneas em 50%, disponibilizando-se à sociedade 21 córneas.

Objective: Describe the epidemiological profile of cornea donors in the state of Goias. Methods: We used a random sample of 793 records calculated by the formula of Leslie Kish (Epi Info 7) taking into account a total of 3,093 records from January 2006 to August 2015. The data was analyzed using the Statistical Package for Social Sciences (SPSS) and the results were described using proportions, central tendency and dispersion measures. Comparisons between categorical variables were made using the chi-square test with 5% significance level. Results: The mean age was 37.33 years, and the majority was male (81.21%). The most frequent cause of death was traumatic brain injury (34.04%) followed by acute myocardial infarction (14.12%). Among the first five years, the time between death and enucleation was 4.7 ± 1.7 hours while that in recent years was 4.9 ± 1.6 hours. Time between death and preservation was 13 ± 4.6 hours in the period 2006 to 2010 and 11.4 ± 4.7 hours in 2011 to 2015 (p

Objetivo: Quantificar os potenciais doadores de córnea no Hospital Universitário Evangélico de Curitiba e comparar com os reais doadores. Separá-los conforme as unidades hospitalares onde foram atendidos. Verificar as principais causas base de óbito dos mesmos. Na impossibilidade de doação, evidenciar os critérios de exclusão mais prevalentes. Métodos: Estudo descritivo retrospectivo, realizado a partir da revisão de prontuários e atestados de óbito dos falecimentos ocorridos entre abril e julho de 2006 no Hospital Universitário Evangélico de Curitiba. Levantamento dos critérios de exclusão para doação, analisando: causa "mortis" e causa base do óbito, entre outros parâmetros. Resultados: Foram analisados 516 prontuários. Natimortos, recém-nascidos até dois anos e pacientes não identificados foram excluídos, totalizando uma amostra de 466 pacientes. Desses, 302 (64,8%) foram considerados potenciais doadores, 164 (35,2%) não-doadores. Dentre os 302 potenciais doadores houve apenas duas doações. Esse número representa 0,7% das possíveis doações. A principal causa base de óbito foi neoplasia maligna (29,8%). A maioria dos potenciais doadores foi a óbito no Pronto Socorro (22,2%), seguido por: UTI geral (10,5%). Os critérios de exclusão identificados foram: Septicemia (87,2%), linfoma ativo disseminado (4,3%), leucemia (3,7%), morte por causa desconhecida (3,0%), encefalopatia viral ativa (1,2%) e hepatite C (0,6%). Conclusão: Quando comparado ao número de potenciais doadores, o número efetivo de doações de córneas é muito pequeno. O setor de maior prevalência de potenciais doadores foi o Pronto Socorro. A principal causa base de óbito dos mesmos foi neoplasia. A maior causa de exclusão de potenciais doadores foi septicemia.

Purpose: The aim of this study was to report the results of the use of real-time polymerase chain reaction (PCR) for the diagnosis of hepatitis B virus (HBV) infection in cornea donors at the Central Eye Bank of Iran. Methods: Between 2014 and 2016, all cornea donors that had negative screening serologic results for hepatitis B (HB) surface antigen, HB surface antibody (Ab), hepatitis C virus Ab, human immune deficiency virus Ab, human T-cell leukemia virus Ab, and syphilis, and positive serology for HB core Ab were subjected to real-time PCR with a detection limit of 400 IU/mL to identify HBV DNA. Positive results for HBV DNA were considered occult HBV infections in these donors. Results: Over the 3-year period, 122 out of 10448 cornea donors had negative screening serologic tests outside of HB core Ab. Of which, 90 cases were subjected to real-time PCR. Occult HBV was detected in 11 cases (12.2%), resulting in the rejection of the corresponding corneas. The remaining 79 cases (87.8%) had negative results for HBV DNA and the corresponding corneas were used for transplantation. Conclusion: Implementation of PCR for the detection of occult HBV in cornea donors is necessary to not only increase the security level of cornea donation but also minimize the rejection rate of donors that have isolated HB core Ab reactivity.

Aim We analysed the number of the potential cornea donors of the Martin-Luther-University, Halle-Wittenberg over a four-years period, 1995 to 1998 in relationships to the number of the actual donors. Patients and methods We retrospectively reviewed the data of 2545 patients who died at the hospitals of the Martin-Luther-University, Halle-Wittenberg over a four-years period, from January 1995 to December 1998. The medical records of the patients were inspected and contraindications for cornea donation examined. The patients who were younger than 12 months were omitted in our analysis. The patients with at least one contraindication were excluded as potential cornea donors. Additionally we registered the actual cornea donors of the hospitals of the Martin-Luther-University, Halle-Wittenberg between 1995 to 1998. Results The mean age of the died patients was 60 years. Because of contraindications 597 patients (23.5 %) were excluded from the cornea donation. An acute sepsis with 25.1 % as well as leukemias and lymphomas with 24.8 % matched about half of the exclusion criteria. In the period of investigation we counted 1948 potential cornea donors. In the hospitals of the Martin-Luther-University, Halle-Wittenberg only 57 (2.9 % of potential donors) actual cornea donors have been registered. Conclusions The possible leading causes for the large discrepancy between the number of the potential and actual donors are: (1) the imperfect identification of potential donors, (2) the donor family have not been asked and (3) the denial of consent by the potential donors family.

Purpose. We have noticed that the incidence of positive serological tests of hepatitis C virus (HCV) among cornea donors in our eye bank is higher than expected. The purpose of this study was to determine the incidence of these positive findings and identify the contributory risk factors.

Tissue procurement and transplantation are rarely taken into account as indicators of the efficiency of a regional donor procurement network. We present herein a retrospective review on Tuscany tissue procurement activities from 2004 until 2006. In 2003 the Tuscan Regional Government appointed a transplantation service authority to reorganize all regional donation and transplantation activities: the Organizzazione Toscana Trapianti (OTT). The regional tissue procurement network was based on either brain death (BD) and cardiac death (CD) donors under the responsibility of in-hospital transplantation coordinators (IHTCs). From 2004 to 2006, a total of 397 tissue donors were procured in Tuscany, and 4151 tissue transplantations were performed: 2909 skin grafts, 1209 bone grafts, and 33 heart valves. Over the same period, a total of 2116 cornea donors were procured; 4117 corneas were retrieved; 1779 were fit for transplantation, and 1418 were transplanted. Based on our experience, implementation of tissue procurement requires use of BD donors and paramount organizational efforts from IHTCs.

Summary Objective: Commercial available NAT systems are usually not validated for screening of post-mortem blood samples. NAT testing might be challenging due to inhibitory substances in the cadaveric blood sample that cause falsely negative test results. Validation studies have to be performed to show the performance characteristics of the NAT assays for testing cadaveric blood. Methods: A set of 32 post-mortem serum and plasma samples from cornea donors and 20 control samples from blood donors, serologically and NAT negative for all investigated parameters, were spiked with defined concentrations of WHO reference material and tested for HIV-1, HCV, HBV, and HAV by NAT using DRK Baden-Wurttemberg-Hesse CE PCR kits. Analytical sensitivity, analytical specificity and reproducibility/precision were validated and compared with each other in both groups of samples. Results: The analytical sensitivity was 100% for control and post-mortem specimens when spiked with virus standards at concentrations of 3 × level of detection (LOD). Invalid results did not occur. The analytical specificity rate for all assays was 100%. Intra-assay variation was analyzed as a function of sample material and sampling time post mortem. Values of % coefficient of variation (%CV) were comparable for serum and plasma but slightly higher for post-mortem samples especially for those samples collected more than 24 h post mortem. Conclusion: Based on the presented validation, postmortem donor samples can be tested with the automated DRK Baden-Wurtemberg-Hesse NAT system.

Serologic testing results are one of the major reasons for discarding donor corneas. This study assessed the prevalence of serologic markers and the times of preanalytic steps. The prevalence of serologic markers in 705 cornea donors of the Lorraine region was studied. One hundred forty-one (20%) corneas were discarded on the basis of serologic testing. In a subsample of 180 consecutive cornea donors, data concerning the time of death, sampling, and serology testing were collected. When the time between death and sampling did not exceed 8 h (n = 122), immediate decantation (separation of serum from clot) led to less discarding of corneas than delayed decantation (2/46 [4.3%] discarded in the group with immediate decantation versus 13/76 [17.1%] discarded in the group with delayed decantation [P = 0.038]). For blood samples collected within 8 h of death, the rate of reactive results is significantly lower if samples are immediately decanted.

HISTÓRICO: Apesar dos esforços que vêm sendo realizados mais recentemente, a falta de córneas para transplantes ainda é uma realidade no Brasil, principalmente em algumas regiões. O Banco de Olhos do Hospital São Paulo tem como objetivo garantir a qualidade e conservação dos tecidos oculares humanos para disponibilizá-los para transplantes. A qualidade do tecido encontra-se diretamente ligada a todos os processos realizados pela equipe do banco de olhos, a partir da seleção dos doadores. OBJETIVO: Conhecer o perfil dos doadores de córneas do Banco de Olhos do Hospital São Paulo num período de dez anos. MÉTODOS: Estudo retrospectivo de fichas de doadores, no período de janeiro de 1996 a dezembro de 2005. RESULTADOS: Chegaram ao Banco de Olhos do Hospital São Paulo 3.624 córneas. A idade média dos doadores foi de 56,8 anos. A faixa etária com maior doação foi de 70-79 anos. A causa mortis mais freqüente foi doença cardiovascular, seguida por neoplasias, doenças respiratórias e trauma. O tempo "enucleação" foi em média de 3,8 horas e o tempo "preservação" foi em média de 3,6 horas. A maioria dos tecidos foi preservada em meios Optisol GS®. Os doadores jovens tiveram maior proporção de córneas consideradas de qualidade "Excelente" ou "Boa". CONCLUSÃO: Ao longo do período estudado de 10 anos, houve tendência de redução no recebimento de tecidos de outros bancos de olhos e progressivo aumento na captação e preservação de tecidos pela equipe do próprio Banco, com redução significativa no tempo de preservação dos tecidos. Os doadores foram, na maioria, do sexo masculino e as doenças cardiovasculares lideraram as causas de óbito. Apesar da maioria das córneas serem provenientes de doadores acima de 60 anos, o maior percentual de aproveitamento de córneas para transplantes ópticos foi de doadores jovens.

We determined the human leucocyte antigen (HLA)-A, -B and -DR allele frequencies in recipients and donors of 115 cornea transplants, for recipients who developed graft rejection and those who did not. No difference in HLA allele frequencies of the recipients was found. The frequencies of the HLA-A26, -B35 and -B44 alleles in cornea donors were increased in recipients who developed graft failure. The detrimental effect on corneal graft survival of these alleles was significant (p0.001). No such effect was observed in renal transplantation. Corneal graft survival was similar when one or two A26, B35 or B44 alleles were present on the donor cornea. The negative effect was similar in magnitude to the previously reported negative effect of an HLA-B locus match between donor and recipient. When both a B-locus match and an A26, B35 or B44 allele were present, the negative effect on graft survival was twice as strong, indicating that different immune mechanisms are responsible for these phenomena.

We retrospectively examined Michigan Eye-Bank and Transplantation Center data on all eye/cornea donors in Michigan and Illinois for whom human immunodeficiency virus (HIV) antibody screening results were available. This was done to compare the HIV-antibody positive serology rate in hospital versus medical examiner donors. This population consisted of 3,783 donor records for the period January 1, 1986 through June 30, 1988--a 30-month period. Of these, 2,628 records were from hospital donors, and 1,155 were medical examiner cases. Of the 2,628 hospital donors, 22 (or 0.83%) tested positive for HIV antibody. Ten of the 1,155 medical examiner donors (or 0.87%) tested positive for HIV antibody. We examined donor demographics of gender, race, age, positive hepatitis B surface antigen, and residence for each group. The difference in the HIV antibody-positive rate between the two groups--hospital and medical examiner donors--is 0.04%, with a slightly higher rate in the medical examiner group. The chi-square was 0.0079, and the p-value was 0.928. We conclude that this difference is neither clinically nor statistically significant.

To assess the influence of donor, environment, and logistical factors on the results of virological testing of blood samples from cornea donors.Data from 670 consecutive cornea donors were analyzed retrospectively. Logistic regression analysis was used to assess the influence of different factors on the results of virological testing of blood samples from cornea donors.The mean annual rate of donors with serology-reactive or not evaluable result was 14.8% (99 of 670) (range 11.9%-16.9%). The cause of donor death by cancer increased the risk of serology-reactive or not evaluable result (P = .0300). Prolonged time between death and post mortem blood removal was associated with a higher rate of serology-reactive or not evaluable result (P < .0001). Mean monthly temperature including warmer months, differentiating between septic and aseptic donors, sex, and donor age had no significant impact on the results of virological testing of blood samples from cornea donors.The cause of donor death by cancer and a prolonged time between death and post mortem blood removal seem to be mainly responsible for serology-reactive or not evaluable result of blood samples from cornea donors. The percentage of discarded corneas caused by serology-reactive or not evaluable result may be reduced by shortening the period of time between death and post mortem blood removal.