Epidemiology of corneal transplantation before achieving the Zero Queue / Epidemiologia do transplante de córnea antes de atingir a Fila Zero

ABSTRACT Objective: To outline the epidemiological profile of cornea donors and recipients before reaching queue zero. Methods: Epidemiological study, of quantitative approach, with transversal, analytical design, analyzing database records from the Health Secretary of the State of Ceará, from 2013 to 2015. Results: We obtained 1,558 cornea donors and 2,287 cornea recipients from 2013 to 2015. Most donors were male, capital residents, from 21 to 40 years old. Of donated eyeballs, 14.52% were disposed, due to poor condition, infiltration or positive serology. The recipients were predominantly women over 60 years old. The procedures were mostly elective, due to bullous keratopathy (28%). Regarding emergency transplants, ulcer (38.51%) and retransplant (35.14%) were most prevalent. Predominantly, transplants were funded by the Unified Health System. Conclusion: The majority of patients who were submitted to corneal transplantation are senile, especially females, therefore should be cautiously observed. On the other hand, donors are mainly male and young, reflecting the high number of tragic accidents. The surgery for bullous keratopathy is the most frequent among elective transplants, while the ulcer surgery is the main cause of emergency procedures. The fact that most surgeries were financed by the Unified Health System reflects the importance of this system.

RESUMO Objetivo: Traçar o perfil epidemiológico dos doadores e receptores de córnea antes de atingir a Fila Zero. Métodos: Estudo epidemiológico, de abordagem quantitativa, com delineamento transversal e analítico, analisando registros da base de dados da Secretaria de Saúde do Estado do Ceará, de 2013 a 2015. Resultados: Foram obtidos 1.558 doadores de córnea e 2.287 receptores de córnea, de 2013 a 2015. A maioria dos doadores era homem, procedente da capital, de 21 a 40 anos. Dentre os globos oculares doados, 14,52% foram descartados por má condição, infiltração ou sorologia positiva. Os receptores eram predominantemente mulheres acima de 60 anos de idade. Os procedimentos foram majoritariamente eletivos, devido à ceratopatia bolhosa (28%). Já para transplantes de emergência, a úlcera (38,51%) e o retransplante (35,14%) foram os mais prevalentes. Em geral, os transplantes foram custeados pelo Sistema Único de Saúde. Conclusão: A maioria dos pacientes submetidos a transplantes de córnea foram do grupo etário senil, principalmente do sexo feminino, devendo esse grupo ser observado com cautela. Em contrapartida, os doadores eram, principalmente, homens e jovens, refletindo o alto número de pessoas que morrem devido a acidentes trágicos. A cirurgia de ceratopatia bolhosa foi a mais frequente dentre os transplantes eletivos; já a de úlcera foi a principal causa dos procedimentos de emergência. O fato de a maioria das cirurgias ter sido financiada pelo Sistema Único de Saúde reflete a importância desse sistema.

Human cornea conservation in coconut water solution / Conservação de córneas humanas em solução de água de coco

ABSTRACT Purpose: The aim of this study was to evaluate the physical and chemical characteristics of coconut water and to analyze the use of coconut water solution for the conservation of human corneas. Methods: This was an experimental and controlled study performed at the Eye Bank of the General Hospital of Fortaleza. The coconut water-based solution was prepared at the Goat Seed Technology Laboratory of the Department of Veterinary Medicine of the State University of Ceará. Discarded corneas from the Eye Bank were divided into two groups for sequential experiments: G1, coconut water-based solution (experimental group), and G2, conservative treatment with OPTISOL GS® (control group). The osmolality of corneas in G1 was analyzed sequentially at 275, 300, 325, 345, 365, and 400 mOsm/L. The viability of the corneas was determined by specular microscopy and biomicroscopy on the first, third, and seventh days. Results: Corneas preserved in a solution of 365 and 345 mOsm/L had a transparency of 8 mm until the third day and had diffuse edema in the periphery, central folds, and partial epithelium loss until the seventh day. The 365-mOsm/L solution was associated with the worst results during follow-up. Corneas placed in Optisol-GS retained their original aspects. Conclusions: Coconut water-based preservative partially maintained corneal transparency and epithelial integrity, especially during the first three days of follow-up. The coconut water-based solutions used were not effective for use as preservatives in a human eye bank.(AU)

RESUMO Objetivos: As características físico-químicas e o baixo custo da água de coco foram fundamentais para o este estudo. Analisar o uso de solução a base de água de coco como meio de conservação de córneas humanas em banco de olhos. Métodos: Estudo experimental e controlado realizado no Banco de Olhos do Hospital Geral de Fortaleza. Utilizou-se solução à base de água de coco preparada no laboratório de Tecnologia de Sêmen de Caprinos do Departamento de Medicina Veterinária da Universidade Estadual do Ceará. Foram usadas córneas de descartes divididas em dois grupos: G1 (Conservante com água de coco) - grupo experimental e G2 (grupo Conservante com OPTISOL GS®) grupo controle, em experimentos sequenciais. A osmolaridade do G1 foi analisada sequencialmente com 275, 300, 325, 345, 365 e 400 mOsm/L. A viabilidade das córneas foram realizadas por microscopia especular e biomicroscopia nos 1º, 3º e 7º dias. Resultados: As córneas em solução de 365 e 345 mOsm/L apresentavam transparência nos 8mm centrais até o 3º dia, com edema em toda periferia, dobras centrais e edema 2+, com perda parcial do epitélio até 7º dia, sendo o de maior osmolaridade com melhor transparência durante o seguimento. Grupo com 275, 300 e 400 mOsm/L, córnea opaca, edema difuso, perda total do epitélio no 3º dia. As córneas em Optisol mantiveram seus aspectos. Conclusões: O conservante à base de água de coco manteve em parte a transparência corneana e a integridade epitelial, especialmente nos primeiros 3 dias de seguimento. A solução conservante com água de coco nas formulações utilizadas não se mostrou eficaz para o uso em banco de olhos humanos.(AU)

Do Eye Bank Models and Competitive Practice Affect International Cornea Allocation?

PURPOSE: International export and import of corneas is dependent on the stakeholders involved in the process and how those organizations engage to move corneas from one point to another. Our article presents the pathway of corneal donation from the export nation until its use in the import nation. It presents opinion on how aspects, such as competition and promotional behaviors, the use of online systems, and third-party engagement may influence allocation. METHODS: We interviewed n = 92 international eye tissue and eye bank (EB) professionals to garner their opinion. We used saturation and sentiment methods to extract and consolidate group opinion. RESULTS: Interviewees indicated that competition and promotional behaviors existed in some EB nations-although it was not universal. They indicated that the behavioral approach used by the individual EB, rather than the act of information sharing, influenced allocation. They also indicated that organizational models and allocation systems (eg, online ordering) and engagement with nonstate actors were important in allocation practice and decision making. CONCLUSION: We mapped the pathways for corneas involved in export and import from the point of recovery to their point of transplantation. Although generalist in nature and limited by the paucity of the existing literature, our article outlines that different business models, partnerships, and applied methods influence corneal export and import.

Should Donors Consent to Export Their Corneas? Examination of Eye Tissue and Eye Care Sector Opinion.

PURPOSE: Corneal tissue international activity is only possible because of the willingness of export populations to donate their corneas on their death. Current predonation public education campaigns and at-the-point-of-donation consent practice generally includes consent for transplantation, research, and/or training. It is unclear whether a consent-for-export step is universally included in the consent process or, indeed, whether it should. We interviewed eye tissue and eye care professionals from around the world, who exported, imported, or did neither to understand current consent-for-export awareness and determine opinion on future practice. METHOD: During wider qualitative grounded-theory semistructured interviews with sector experts, to determine whether Australia should export, we captured sector opinion on consent-for-export. We used saturation and sentiment methods to determine opinion and χ2 correlation coefficients to examine association, using an α of P = 0.05. RESULTS: We interviewed 92 individuals, 83 of whom discussed consent-for-export. Of those, 51% (42/83) demonstrated some awareness of the practice; however, there were contradictions between interviewees from the same location. Regardless of current awareness, 57% (41/72) believed donors should be informed or consented for export. Their approval did not extend to donor-directed decisions, which would allow donors to decide which nation their donation should be sent, with 62.5% (45/72) opposing that notion. CONCLUSIONS: Our research indicates that the consent-for-export practice is not universally applied by exporting nations and that eye tissue and eye care professionals have limited awareness of the practice. Universally implementing a consent-for-export step within general consent practice would improve awareness, reduce confusion, and support donor wishes.

Webpalestra COVID-19 (Coronavírus): Bancos de Olhos e Transplantes de Córnea: impactos da pandemia COVID-19 no Brasil

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Eye banking in the coronavirus disease 2019 era.

PURPOSE OF REVIEW: Coronavirus disease 2019, caused by novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is highly infectious; however, the different routes of transmission are not well understood. Transmission through tissue transplantation is possible and must be considered. This review will evaluate the current literature regarding routes of transmission, the likelihood of transmission through ocular tissue transplantation, and the guidelines in place to mitigate this risk. RECENT FINDINGS: Although respiratory droplets have been the primary route of SARS-CoV-2 transmission, there is evidence that transmission through blood donation and organ or tissue transplantation is possible. This includes corneal transplantation, as SARS-CoV-2 has been detected in conjunctival swabs of infected patients, and the ocular surface may play an important role in viral entry. Several tissue transplantation organizations have guidelines in place regarding the screening of donors and tissue procurement procedures, including clinical and/or PCR screening of donors. The Eye Bank Association of America (EBAA) is currently not recommending asymptomatic PCR screening. However, their antiseptic protocols may play an important role in viral inactivation. SUMMARY: Based on the current literature and guidelines, the risk of SARS-CoV-2 transmission through corneal transplantation is likely low. However, tissue screening guidelines need to be re-evaluated regularly as knowledge regarding the SARS-CoV-2 virus evolves.

Procurement, storage and utilization trends of eye banks in India.

Purpose: To study the trends in collection, storage and utilization of donor corneas in eye banks in India. Methods: The data was collected from 12 eye banks in India that collected more than 1000 corneas per year. The retrospective analysis of the parameters like characteristics of the donor and the host, storage media used, number of eyes collected, number of eyes utilized, causes of non-utilization of the tissue and the procedures performed was done. Results: A total of 20,564 eyes were collected by the 12 eye banks during the year 2013-2014. Voluntary eye donation (VED), and hospital cornea retrieval program (HCRP) contributed to 59.6% and 40.4% of tissue procurement respectively. Whole globe enucleation (52.3%) was more commonly performed as compared to in-situ excision of the donor corneas. The most commonly used storage media at all eye banks was McCarey-Kaufman (MK) media (83.3%). The utilization rate of the donor eyes was 50.5%. The most frequent indication for corneal transplantation was infection (active infection - 33.13%, healed infection - 10.78%) followed by Pseudophakic bullous keratopathy (PBK) (13.57%). Full thickness keratoplasty (optical penetrating keratoplasty - 47.23%, therapeutic penetrating keratoplasty - 31.74%) was performed most often followed by endothelial keratoplasty (12.41%) in the developing country. Conclusion: VED still contributes to majority of the donor tissue retrieval in India. The majority of the eye banks still utilize whole globe enucleation technique and store tissues in MK media. Trends from previous years showed a change towards HCRP, in-situ excision technique and preservation in the long-term storage media.

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.

Eye donation and eye banking in India.

Corneal blindness is a priority condition under the National Programme for Control of Blindness and an important cause of avoidable blindness in India. A multipronged approach is needed to eliminate corneal blindness. Curable or treatable blindness requires a spectrum of care including medication, optical rehabilitation and corneal transplantation. Corneal transplantation is dependent on the availability of safe, donor eyes; however, there is scarcity of donor corneal tissues in India. To improve the eye banking system, the Government of India supports eye banks through recurring grants for operational costs and non-recurring grants for infrastructure costs. Strategic interventions by the government and non-governmental organizations include awareness by health promotion and education, community participation, sustainable source of donor cornea, quality medical standards, accreditation and endeavours to strengthen eye banking systems and procedures through training and research. A model eye banking system in India can be achieved only when it is linked with the targeted infrastructure proposed under 'Vision 2020: Right to Sight- India'. Considering these targets, there is a requirement of at least 20 eye bank training centres, 200 eye banks with corneal transplant facility (collection of nearly 500 corneas per year) and 2000 eye donation centres in the country. This would become a reality if the Hospital Cornea Retrieval Programme is strengthened at all private and government hospitals, uniform medical standards are made mandatory for all eye banks and eye donation centres and the process of registration and eye donation is simplified to enhance community participation.

Alternatives to eye bank native tissue for corneal stromal replacement.

Corneal blindness is a major cause of blindness in the world and corneal transplantation is the only widely accepted treatment to restore sight in these eyes. However, it is becoming increasingly difficult for eye banks to meet the increasing demand for transplantable tissue, which is in part due to population aging. Donor tissue shortage is therefore a growing concern globally and there is a need for alternatives to human donor corneas. Biosynthetic corneal substitutes offer several significant advantages over native corneas: Large-scale production offers a powerful potential solution to the severe shortage of human donor corneas worldwide; Good manufacturing practices ensure sterility and quality control; Acellular corneal substitutes circumvent immune rejection induced by allogeneic cells; Optical and biomechanical properties of the implants can be adapted to the clinical need; and finally these corneal substitutes could benefit from new advances in biomaterials science, such as surface coating, functionalization and nanoparticles. This review highlights critical contributions from laboratories working on corneal stromal substitutes. It focuses on synthetic inert prostheses (keratoprostheses), acellular scaffolds with and without enhancement of endogenous regeneration, and cell-based replacements. Accent is put on the physical properties and biocompatibility of these biomaterials, on the functional and clinical outcome once transplanted in vivo in animal or human eyes, as well as on the main challenges of corneal stromal replacement. Regulatory and economic aspects are also discussed. All of these perspectives combined highlight the founding principles of the clinical application of corneal stromal replacement, a concept that has now become reality.

Upgradation and modernization of eye banking services: Integrating tradition with innovative policies and current best practices.

PURPOSE: The purpose of this study is to review the history and evolution of the National Eye Bank (NEB) and analyze the impact over the years and report the outcome of the invested resources. METHODS: Review of archival material, records, project reports, policy and procedures' manuals, and publications was done. Descriptive and analytical processing of data obtained was undertaken. Parameters evaluated included total collection, transplantation, utilization rates of donor cornea, changing trends over time in terms of numbers and duration of recipients waiting, impactful research translated into changes in standard operating protocols, new facilities, and subsequent effects on numbers or quality assurance measures and overview of major achievements. Periodic situational analysis with contextual relevance and interpretation of outcomes was done pertaining to national goals and international standards. RESULTS: The NEB and cornea services have played a key leadership role in furthering the development of eye banking and corneal transplantation services. The contribution extends beyond routine patient care to education, training, generation of resources, advocacy, and policymaking. In quantifiable terms, the overall performance has steadily increased over the years. Major contributions include training of doctors, eye bank staff and corneal surgeons, introduction of innovative techniques for corneal transplantation, setting of national standards for eye banking and provision of preservation media, customized corneal, and ocular surface cell replacement therapy in collaboration with other departments and institutes. CONCLUSION: The eye banking and corneal transplantation facilities have evolved with time providing quality services, modernized as appropriate with updated knowledge and incorporating technological advances supported by the systematic evidence-based approach.

Ethical Issues in Transnational Eye Banking.

PURPOSE: To review ethical issues that may arise in the setting of transnational eye banking activities, such as when exporting or importing corneal tissue for transplantation. METHODS: A principle-based normative analysis of potential common dilemmas in transnational eye banking activities was performed. RESULTS: Transnational activities in eye banking, like those in other fields involving procurement and use of medical products of human origin, may present a number of ethical issues for policy makers and professionals. Key ethical concerns include the potential impact of export or import activities on self-sufficiency of corneal tissue supply within exporting and importing countries; potential disclosure requirements when obtaining consent or authorization for ocular tissue donation when donations may be exported; and difficulties inherent in assuring equity in the allocation of tissues available for export and in establishing and respecting standards of safety and quality across different jurisdictions. CONCLUSIONS: Further analysis of specific ethical issues in eye banking is necessary to inform development of guidelines and other governance tools that will assist policy makers and professionals to support ethical practice.

[Pay attention to the donor material supply for corneal transplantation].

Corneal transplantation is an important method in the treatment of corneal blindness. It is imperative to improve the treatment effectiveness of corneal disease and reduce the possibility of corneal blindness with the progress of corneal transplantation surgery, the construction and development of eye banks and the rational use of donor materials. This article reviews the component corneal transplantation technology promotion, eye bank construction and preparation of donor slices for component corneal transplantation surgery. (Chin J Ophthalmol, 2016, 52: 641-643).

Report of the Eye Bank Association of America Medical Review Subcommittee on Adverse Reactions Reported From 2007 to 2014.

PURPOSE: To investigate the incidence of adverse reactions after corneal transplantation, reported to the Eye Bank Association of America. METHODS: Incidence of adverse reactions from January 1, 2007, to December 31, 2014, was analyzed. RESULTS: Of the 354,930 transplants performed in the United States, adverse reactions were reported in 494 cases (0.139%). Primary graft failure (PGF) predominated (n = 319; 0.09%) followed by endophthalmitis (n = 99; 0.028%) and keratitis (n = 66; 0.019%). The procedure type predominantly associated with PGF was endothelial keratoplasty (EK) in 56% (n = 180; 11 per 10,000 grafts), followed by penetrating keratoplasty (PK) in 42% (n = 135; 6.9 per 10,000 grafts). The procedure type predominantly associated with endophthalmitis and keratitis was EK in 63% (n = 104; 6.3 per 10,000 grafts) followed by PK in 34% (n = 56; 2.8 per 10,000 grafts), anterior lamellar keratoplasty in 1% (n = 2; 2.7 per 10,000 grafts), and keratoprosthesis in 1% (n = 2; 12.4 per 10,000 grafts). Although the incidence of PGF and endophthalmitis between PK and EK was noteworthy, the difference was not statistically significant (P = 0.098). Endophthalmitis-associated pathogens were isolated in 78% of cases: predominantly Candida species (65%), gram-positive organisms (33%), and gram-negative rods (2%). Keratitis-associated pathogens were isolated in 64% of cases: predominantly Candida species (81%), Herpes simplex virus (7%), gram-negative organisms (7%), and gram-positive organisms (5%). CONCLUSIONS: PGF was the most commonly reported adverse reaction, disproportionately associated with EK. An increasingtrend in the rate of endophthalmitis and keratitis was observed, disproportionately associated with EK and Candida species.

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.