National Consensus on Contraindications for Corneal Donation for Transplantation in Switzerland.

PURPOSE: To establish a national consensus on contraindications for corneal donation for transplantation in Switzerland. METHODS: Swisstransplant (SWT), the Swiss national foundation coordinating tissue and organ donations, convened a working group consisting of six national corneal surgeons and eye bankers and donation experts to create a contraindication list for corneal donation. The group reviewed available national and international guidelines and recommendations, while adhering to Swiss law and transplant regulations. In cases of opposing opinions, the group held follow-up meetings until a consensus was reached. A consensus was defined as agreement among all parties present. RESULTS: From March 2021 to November 2021, the study group held six meetings and created a standardized minimal contraindication list for corneal donation in Switzerland. Thanks to this list, SWT has created a mandatory working and documentation file for donor coordinators to use when evaluating multiorgan donors for corneal harvesting. The authors agreed that while the national consensus list provides standardized minimal contraindication criteria, local eye banks may choose to introduce additional, more rigorous criteria. CONCLUSION: Given that corneal transplantation is the most commonly performed transplantation, establishing a consensus on contraindications is crucial for recipient safety. The creation of a consensus on contraindications for corneal donation in Switzerland is an essential contribution to fulfil the legal requirements concerning quality assurance and provides sufficient high-quality donor tissue within the country. Therefore, periodic review and revision of the consensus is considered critical.

Association of Federal Regulations in the United States and Canada With Potential Corneal Donation by Men Who Have Sex With Men.

Importance: Federal policy in the United States prohibits corneal donation by men who have had sex with another man (MSM) in the preceding 5 years, whereas Canada enforces a 12-month ban. The potential consequences of these policies on corneal donations should be evaluated. Objective: To estimate the number of potential corneal donations associated with MSM deferral policies in the United States and Canada. Design, Setting, and Participants: A nonvalidated telephone survey study was conducted of all 65 eye banks in the United States and Canada to investigate how many potential corneal donors were disqualified in 2018 because of federal MSM restrictions. Published demographic data were also used to arrive at a separate estimate. Survey data were gathered from May 2019 to February 2020. Main Outcomes and Measures: Eye banks were asked if they keep records of referrals disqualified specifically because of the federal MSM restrictions and, if so, how many referrals they disqualified in 2018 owing to MSM status. Results: Fifty-four of 65 eye banks (83%) responded to the survey, with 30 eye banks reporting they do not keep specific records of MSM deferrals. The remaining 24 eye banks reported disqualifying 360 referrals in 2018 because of MSM status, equating to 720 corneas. The 24 eye banks accounted for 46.2% of corneal donations in the United States and Canada in 2018, yielding an estimate of approximately 1558 corneas rejected that year because of MSM status. A separate estimate using published MSM demographic data indicates that up to 3217 potential corneal donations may have been disqualified in 2018 because of these federal policies. Conclusions and Relevance: Findings suggest that between 1558 and 3217 corneal donations were disqualified in 2018 because of federal regulations prohibiting corneal donation by men who have had sex with another man in the preceding 5 years in the United States or 1 year in Canada. With modern virologic testing that is reliable within days of HIV exposure and given the global shortage of corneal tissue, these policies should be reevaluated using current scientific evidence to increase the availability of vision-restoring surgery worldwide.

Análise crítica das diferentes fontes de dados sobre transplante de córnea no Brasil / Critical analysis of the different data sources on corneal transplantation in Brazil

Resumo As doenças da córnea são responsáveis por cerca de 4 a 5% da cegueira reversível no mundo. O transplante de córnea é o tecido mais transplantado em todo o mundo e o único tratamento amplamente aceito para promover a transparência corneana e restaurar a visão. O monitoramento incorporou-se ao campo da Saúde Pública, com o objetivo de acompanhar sistematicamente a atuação das equipes e os dados de produção, por meio da criação de normas, inspeções de avaliação periódicas e acompanhamento dos indicadores de qualidade. As análises críticas dos resultados objetivam apontar falhas e riscos envolvidos no processo, e empreender ações capazes de modificar os achados negativos, a fim de aprimorar a qualidade dos serviços prestados à população. No Brasil, existem diferentes fontes de dados sobre transplantes de córnea e bancos de tecidos oculares. Nesta revisão, foi avaliada a precisão dos dados e a confiabilidade das informações divulgadas pelo Sistema Nacional de Transplantes, pela Associação Brasileira de Transplante de Órgãos e pela Agência Nacional de Vigilância Sanitária sobre a situação do transplante de córnea no Brasil, a fim de nortear governos, gestores em saúde pública e pesquisadores.

Abstract Corneal diseases account for about 4 to 5% of reversible blindness in the world. Corneal transplantation is the most transplanted tissue in the world and the only widely accepted treatment to promote corneal transparency and restore vision. Monitoring was incorporated into the field of Public Health, with the objective of systematically monitoring teams' performance and production data, through the creation of norms, periodic evaluation inspections and monitoring of quality indicators. The critical analyzes of the results aim to point out flaws and risks involved in the process, and to undertake actions capable of modifying the negative findings, in order to improve the quality of the services provided to the population. In Brazil, there are different sources of data on corneal transplants and ocular tissue banks. In this review, the accuracy of the data and the reliability of the information disclosed by the National Transplant System by the Brazilian Organ Transplant Association and the National Sanitary Surveillance Agency on the situation of corneal transplantation in Brazil were evaluated in order to guide governments, public health managers and researchers.

Use of corneas for transplant after self-inflicted eyeballs enucleation in the Italian law.

The authors analyze from an ethical and legal point of view the case of a 37 year old man, hospitalized for four days because of a 'dissociative syndrome', who had introduced in both his orbits a portable radio antenna. Most likely, he completed the self-enuclation using his own hands. He was brought to the Ophtalmic Hospital by nurses who handed the two eyeballs to the physicians who ascertained that the corneas were intact. Then, they performed the conservative extraction. In the following days those corneas were transplanted (keratoplasty) on two subjects on the waiting list at that hospital. The case raises the question of whether it is lawful and ethically acceptable to take, for transplant use, the corneas of a mentally incapable patient who has excised his own eyeballs. The authors analyze the case from the angle of the Italian law and Oviedo Convention. Neither of them has a specific regulation on this topic. It is therefore necessary to apply general principles that holdvalidfor Italy and a variety of countries worldwide. Particularly, the choice to use the corneas for transplant did not prejudice the physical integrity of the patient, who could no longer utilize his own eyeballs. His self-determination has not been affected; in fact, he was not in the position to make a conscious decision. Additionally, the so-called "implied consent" could be applied. Therefore, the principle of human solidarity, which is the moral duty to benefit others, seems to prevail in the case at hand.

Doação e fila de transplante de córnea no Estado do Rio de Janeiro / Donation and waiting list for corneal transplantation in the State of Rio de Janeiro

O presente trabalho objetiva descrever o processo de doação, captação, fila de espera e transplante de órgãos e tecidos como uma das políticas de saúde no Brasil e no Estado do Rio de Janeiro, com ênfase nos procedimentos relativos aos transplantes de córnea. A baixa notificação de possíveis doadores e a alta taxa de negativa familiar na doação associado ao insuficiente número de córneas disponibilizadas por Banco de Olhos são os principais fatores que limitam o aumento do número dos transplantes de córnea no Brasil. A criação do Banco de Olhos do Rio de Janeiro, associado a politicas que estimulam o aumento da notificação e captação de córneas visa diminuir a fila de espera para transplante de córnea no Estado.

This paper aims to describe the process of organ and tissue donation, tissue harvesting, queue and transplants as a health policy in Brazil and in the State of Rio de Janeiro, with emphasis on procedures for corneal transplantation. The low reporting of possible donors associated with a high rate of negative family in donation, associated with the insufficient number of corneas provided by Eye Banks are the main factors limiting the increase in the number of corneal transplants in Brazil. The creation of the Rio de Janeiro Eye Bank associated with policies that encourage increased reporting and collection of corneas aims to reduce the waiting list for corneal transplantation in Rio de Janeiro State.

Ethical and regulatory guidelines in clinical trials of xenocorneal transplantation in Korea; the Korean xenocorneal transplantation consensus statement.

BACKGROUND: To establish the consensus about the conditions for undertaking clinical trials in xenocorneal transplantation in Korea, specific issues regarding the xenocorneal transplantation on ethical and regulatory aspects are addressed, and the guidelines to conduct clinical trial of the xenocorneal transplantation are proposed. METHOD AND RESULTS: Chapter 1 reviews the key ethical requirements and progress of a Korean regulatory framework for clinical trials of xenocorneal transplantation. Chapters 2-7 provide recommendations on source pigs, quality control of porcine corneal procurement, preclinical efficacy required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus (PERV), patient selection for clinical trials, and informed consent in xenocorneal transplantation using either cellularized or decellularized porcine graft, which are essentially based on the International Xenotransplantation Association (IXA) islet xenotransplantation consensus statement. The consensus statement of the inclusion criteria for the patients' selection has been made by the executive board members in Korean External Eye Disease Society. CONCLUSIONS: This consensus statement will be a good initiative for Korean Food and Drug Administration to discuss final regulatory guidelines in conducting clinical trials of xenocorneal transplantation in Korea and for International Xenotransplantation Association to develop International Consensus Standards of Xenocorneal Transplantation.

Sustainability of Routine Notification and Request legislation on eye bank tissue supply and corneal transplantation wait times in Canada.

OBJECTIVE: To assess whether provinces with Routine Notification and Request (RNR) legislation have sustained increases in corneal tissue supply and decreases in wait times for corneal transplantation surgery. DESIGN: Cross-sectional survey of Canadian corneal transplant (CT) surgeons and eye banks. PARTICIPANTS: Canadian CT surgeons and representatives from the 10 Canadian eye banks. METHODS: Voluntary and anonymous surveys were distributed between July and October 2009. Eligible CT surgeons were defined as ophthalmologists who practice in Canada; currently perform Penetrating keratoplasty (PKP), Deep anterior lamellar keratoplasty (DALK), Deep lamellar endothelial keratoplasty (DLEK), Descemet stripping endothelial keratoplasty (DSEK), or Descemet membrane endothelial keratoplasty (DMEK); and have obtained tissues from a Canadian eye bank. RESULTS: From 2006 to 2009, for provinces with RNR legislation and where data are available, mean wait times from date of diagnosis to date of CT surgery have increased: in Ontario, from 31 ± 34 weeks to 36 ± 27 weeks; in British Columbia, from 39 ± 20 weeks to 42 ± 35 weeks; in Manitoba, from 32 ± 23 weeks to 49 ± 36 weeks. In addition, the amount of corneal tissue in RNR provinces suitable for transplant, with the exception of British Columbia, has declined between 2006 and 2008: in Ontario, 1186 tissues to 999 tissues (16% decline); in Manitoba, 92 tissues to 83 tissues (10% decline); in New Brunswick, 129 tissues to 98 tissues (24% decline). CONCLUSION: Although initially effective, RNR legislation has not sustained an increase in corneal tissue availability nor has it shortened wait times in most provinces. Incorporation of community hospitals into the RNR catchment, improved enforcement, and continued education of hospital staff regarding the RNR process may be effective in making this legislation more sustainable in the long term.

[The 2009 performance report of the German cornea banks]. / Leistungsbericht der Deutschen Hornhautbanken 2009.

BACKGROUND: In Germany, human tissue for corneal and amniotic transplantation is supplied by 27 cornea banks. METHODS: The Section for Tissue Transplantation and Biotechnology of the German Ophthalmological Society records the cornea banks' activities by means of an annual questionnaire. RESULTS: In 2009, a total of 4,818 corneal grafts were processed by 21 responding cornea banks, and 57% were deemed suitable for transplantation. This ratio is slightly higher than the European average. In addition, German cornea banks released 1,257 amniotic grafts in 2009. DISCUSSION: German cornea banks are currently facing new regulatory issues due to updated legislation regarding tissue transplantation. Recent updates in European law have limited the cutoff time for postmortem blood sampling to 24 h, and this regulation may lead to a significant reduction in potential donors.

Practical implications of the law on tissues for cornea banks in Germany.

ISSUE: On August 1, 2007, the Law on the Quality and Safety of Human Tissues and Cells came into force. IMPLICATIONS: As a consequence of the new legislation on human tissue, legislative changes were effected upon the Law Regulating Transplantations, Medicine Law and Transfusion Law and the regulation of pharmacies as well as the operating regulations for wholesale pharmaceutical holdings. RESULTS AND CONCLUSION: The substantial increase in regulation caused by the Tissue Act far exceeds the requirements of the EC directive on tissues. As such, it has resulted in a huge increase in material (financial, human) and bureaucracy, with no significant gains in safety or quality in an area that had functioned well under the previous legislation.

Efficacy of Routine Notification and Request on reducing corneal transplantation wait times in Canada.

OBJECTIVE: To determine whether the implementation of Routine Notification and Request (RNR) has been effective in increasing the amount of donor corneal tissue available and reducing wait times for corneal transplant (CT) surgeries. DESIGN: Survey of the CT surgeons and eye banks in Canada. PARTICIPANTS: CT surgeons and representatives of the 10 eye banks in Canada. METHODS: Voluntary, anonymous questionnaires were distributed between May 1 and September 30, 2006. RESULTS: Following the implementation of RNR, 3 eye banks had an increase in the amount of corneal tissue available: Manitoba, 81% (from 42 tissues in 2004 to 76 tissues in 2006); Ontario, 25% (from 1304 tissues in 2005 to 1626 tissues in 2006); New Brunswick, 129% (from 86 tissues in 2005 to 197 tissues in 2006). British Columbia, where RNR was implemented in 1999, had a 6% increase (from 766 in 2005 to 812 in 2006). There has been a significant decrease in wait times from the time of diagnosis by CT surgeons to the time of surgery in British Columbia (from 48+/-18 weeks in 2004 to 39+/-20 weeks in 2006), Manitoba (from 82+/-56 weeks in 2004 to 32+/-23 weeks in 2006), Ontario (from 82+/-56 weeks in 2004 to 31+/-34 weeks in 2006), and Nova Scotia (from 44+/-12 weeks in 2004 to 32+/-28 weeks in 2006). CONCLUSIONS: RNR has been effective in increasing corneal tissue availability and decreasing wait times in provinces where it has been implemented. We recommend similar legislative changes to be considered in those provinces where corneal tissue shortage is delaying the availability of CT surgery.

[Problems and strategies of corneal surgery in China].

Corneal surgery covers corneal refractive surgery and corneal transplantation. Though China has ranked the first in the number of LASIK performed in the world, lack of accredited subspecialty division, surgical admission system and professional administration in the field of refractive surgery prevents the further development of LASIK techniques. However, corneal transplantation techniques of China have been greatly improved in the international level. But the major constrains are legal, storage and screening standards of donor corneas.

[Transplantation and donation of tissues--six years with the new law. Experiences from the tissue bank in Lund]. / Transplantation och donation av vävnader--sex år med nya lagen. Erfarenheter från vävnadsbanken i Lund.

Tissue transplantation is more common than organ transplantation. Legislative changes in 1996 transformed tissue banking and conditions for tissue transplantation in Sweden. After an initial decrease in donated tissue, heart valves are now available in sufficient numbers, but there is sometimes a shortage of valves the right size for pediatric cardiac surgery. Since the new transplantation legislation was implemented there has been an increase in the number of valves from neonatal donation and after sudden infant death. The number of donated corneas does not correspond to the number required for transplantation. A number of tissue coordinators have been established throughout the country and recently some new tissue banks were founded to increase the amount of tissue available for transplantation. The organization of the tissue bank in Lund is described. There is a lack of knowledge about tissue transplantation and donation among health professionals as well as the general public, and more education is warranted.

Causes of blindness and needs of the blind in Mansoura, Egypt.

A study of 113 blind people in Mansoura, Egypt highlighted the causes and risk factors for blindness, and health and social care needs of the blind. In two-thirds of cases, blindness occurred before 10 years of age. Risk factors for blindness were reported by more than half the study population. Congenital causes accounted for almost half the cases. The commonest causes of bilateral blindness were corneal opacities, cataract and glaucoma. Almost three-quarters of causes were avoidable. Health and social care for this group was inadequate and more than half would benefit from further management. Legislation for keratoplasty, a registry of blind people, and a nationwide community survey on the epidemiology of blindness are needed urgently.