Practice patterns of corneal transplantation in Europe: first report by the European Cornea and Cell Transplantation Registry.

PURPOSE: To report practice patterns of corneal transplantation in Europe. SETTING: Corneal clinics in 10 European member states (MS), the United Kingdom, and Switzerland. DESIGN: Multinational registry study. METHODS: Corneal transplant procedures registered in the European Cornea and Cell Transplantation Registry were identified. Preoperative donor and recipient characteristics, indication and reason for transplantation, and surgical techniques were analyzed. RESULTS: A total of 12 913 corneal transplants were identified from 10 European Union MS, the United Kingdom, and Switzerland. Most countries were self-sufficient with regard to donor tissue. Fuchs endothelial corneal dystrophy was the most common indication (41%, n = 5325), followed by regraft (16%, n = 2108), pseudophakic bullous keratopathy (12%, n = 1594), and keratoconus (12%, n = 1506). Descemet stripping automated endothelial keratoplasty (DSAEK, 46%, n = 5918) was the most commonly performed technique, followed by penetrating keratoplasty (30%, n = 3886) and Descemet membrane endothelial keratoplasty (9%, n = 1838). Vision improvement was the main reason for corneal transplantation (90%, n = 11 591). Surgical technique and reason for transplantation differed between indications. CONCLUSIONS: This report provides the most comprehensive overview of corneal transplantation practice patterns in Europe to date. Fuchs endothelial dystrophy is the most common indication, vision improvement the leading reason, and DSAEK the predominant technique for corneal transplantation.

Ultrastructural Analysis of Rehydrated Human Donor Corneas After Air-Drying and Dissection by Femtosecond Laser.

Purpose: To evaluate the efficiency of femtosecond laser (FSL) incision of rehydrated human donor corneas after air-drying and its effects on corneal structure. Methods: We compared the rehydrated and fresh-preserved corneas by microscopy following Victus-Tecnolas FSL treatment for straight-edge anterior lamellar keratoplasty (ALK). The corneas were dehydrated at room temperature under a laminar-flow hood. Results: To obtain the horizontal cut in rehydrated corneas, we increased the FSL pulse energy to 1.2 µJ from 0.80 µJ applied for the fresh corneas and obtained a clear-cut separation of the lamellar lenticule cap from the corneal bed. Light microscopy showed regular arrangement of stromal collagen lamellae, with spaces in between the fibers in the corneal stroma in the fresh and the rehydrated corneas, but the uppermost epithelial layers in the rehydrated corneas were lost. Transmission electron microscopy (TEM) revealed no signs of thermal or mechanical damage to the corneal structure. The epithelial basal membrane and Bowman's layer maintained their integrity. The epithelial basal layer and cells were separated by large spaces due to junction alteration in the rehydrated corneas. There were gaps between the lamellar layers in the stroma, especially in the rehydrated corneas. Keratocytes displayed normal structure in the fresh corneas but were devoid of microorganules in the rehydrated corneas. Minor irregularities were observed in the vertical incision and the horizontal stroma appeared smooth on scanning electron microscopy. Conclusion: The corneal stroma of rehydrated corneas maintained morphology and integrity, while corneal cellular components were generally altered. When corneas are intended for FSL-assisted ALK, effective stromal bed incision is best achieved at a laser power higher than that currently adopted for fresh corneas.

Outcomes of corneal transplantation in Europe: report by the European Cornea and Cell Transplantation Registry.

PURPOSE: To analyze real-world graft survival and visual acuity outcomes of corneal transplantation in Europe. SETTING: Corneal clinics in 10 European Union member states, the United Kingdom, and Switzerland. DESIGN: Multinational registry study. METHODS: All corneal transplant procedures registered in the European Cornea and Cell Transplantation Registry (ECCTR) were identified. Graft survival of primary corneal transplants were analyzed using Kaplan-Meier survival curves with log-rank test and Cox regression. Corrected distance visual acuities (CDVAs) are reported at baseline and 2 years postoperatively using the Lundström distribution matrix. RESULTS: A total of 12 913 corneal transplants were identified. Overall, 32-year graft survival of corneal transplants was high (89%) but differed between indications, ranging from 98% in keratoconus and 80% for trauma. Overall, CDVA improved postoperatively, but the risk for losing vision ranged from 7% (baseline vision ≤0.1 Snellen) to 58% (baseline vision ≥1.0 Snellen). CONCLUSIONS: This report provides a comprehensive overview of graft survival and visual outcomes of corneal transplantation in Europe. In addition, it provides real-world estimates of outcomes for a variety of indications and surgical techniques to support benchmarking and demonstrates the relationship between baseline and postoperative vision.

Amniotic membrane in ophthalmology: properties, preparation, storage and indications for grafting-a review.

The use of amniotic membrane in ophthalmic surgery and other surgical procedures in the fields of dermatology, plastic surgery, genitourinary medicine and otolaryngology is on the increase. Furthermore, amniotic membrane and its epithelial and mesenchymal cells have broad use in regenerative medicine and hold great promise in anticancer treatment. Amniotic membrane is a rich source of biologically active factors and as such, promotes healing and acts as an effective material for wound dressing. Amniotic membrane supports epithelialization and exhibits anti-fibrotic, anti-inflammatory, anti-angiogenic and anti-microbial features. Placentas utilised in the preparation of amniotic membrane are retrieved from donors undergoing elective caesarean section. Maternal blood must undergo serological screening at the time of donation and, in the absence of advanced diagnostic testing techniques, 6 months postpartum in order to cover the time window for the potential transmission of communicable diseases. Amniotic membrane is prepared by blunt dissection under strict aseptic conditions, then is typically transferred onto a nitrocellulose paper carrier, usually with the epithelial side up, and cut into multiple pieces of different dimensions. Amniotic membrane can be stored under various conditions, most often cryopreserved in glycerol or dimethyl sulfoxide or their mixture with culture medium or buffers. Other preservation methods include lyophilisation and air-drying. In ophthalmology, amniotic membrane is increasingly used for ocular surface reconstruction, including the treatment of persistent epithelial defects and non-healing corneal ulcers, corneal perforations and descemetoceles, bullous keratopathy, as well as corneal disorders with associated limbal stem cell deficiency, pterygium, conjunctival reconstruction, corneoscleral melts and perforations, and glaucoma surgeries.

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.

European eye bank association.

BACKGROUND: The European Eye Bank Association (EEBA) is a technical-scientific organization for eye banks. Founded in 1989 with the simple objective of sharing information on eye banking, the Association is today the leading pan-national association in Europe dedicated to the advancement of eye banking and an authoritative reference point for eye banks which work according to quality standards. METHODS: The Association establishes and maintains an agreed set of medical and technical standards, promotes the collection of data on eye bank activities and processes, provides opportunities for the discussion of all aspects of eye banking practice, including eye donor selection and procurement, relevant research and development, education and training in eye banking, and maintains linkage with national and international corneal transplant communities and relevant bodies. RESULTS: The recent introduction of a more structured and focused committee, a permanent secretariat, the development of a website has enabled the Association to establish closer links and collaborative activities with key regulatory bodies and to provide a more constant exchange of clinical, scientific and technical ideas and best practice with fellow professionals by means of its annual meetings, the EEBA directory and website, and a regular newsletter. CONCLUSION: The EEBA is a scientific organization committed to defining minimum standards and to encouraging eye banks to maintain the highest possible standards for quality and safety. Through its annual meetings, and the collection and exchange of detailed information from member eye banks, the Association can rightly claim to speak with a confident and representative voice on eye banking in Europe.

Quality management in European eye banks.

BACKGROUND: The European Directive on setting standards of quality and safety for human tissues and cells obliges tissue establishments to implement a quality management system (QMS), based on the principles of good practice, in order to assure a high level of protection with regard to the health of recipients of human tissues. METHODS: A systematic approach to quality management should be used and sustained. Although a number of quality systems can be employed, a recommended reference model is the ISO 9001:2000 standard which is particularly relevant to eye banking as it can be implemented to cover the entire donation-transplantation process to ensure that the tissues distributed, and services offered, by eye banks show uniform safety and quality. RESULTS: The adoption and correct management of a QMS is essential to maximise the benefits and minimise the risks for all those involved in the process. The performance and results of this system must be monitored and measured by appropriate parameters/indicators (positive and negative) which pertain to the structure (personnel, facilities, instruments), the process (the sequence of activities), the outcome (recipient health status or client satisfaction), the efficiency (the costs incurred to produce a certain outcome) and the effectiveness (frequency that the required results are attained). CONCLUSION: Careful attention must be paid to all aspects of the quality of donor tissues in order to maintain confidence in their safety and effectiveness. A well-managed QMS is a valuable and effective instrument to guarantee the required high standards for the donation, procurement, testing, processing, storage, distribution and traceability of ocular tissues as well as to facilitate the continuous improvement and the attainment of the objectives of an eye bank.