Disease of the cornea (the transparent layer covering the front of the eye) is the second cause of blindness worldwide. The cornea is the most transplanted tissue with over 100,000 corneas transplanted annually. In Europe an estimated 30,000 corneal transplants are performed each year.
Currently there is no harmonisation of information across the European Union on the numbers or origins of the scarce corneas tissue available for transplant, the optimum procedure for transplant and the visual outcome and quality of life of corneal transplant patients.
The ESCRS in 2006 with the support of the Executive Agency for Health and Consumers pioneered an online Quality Registry of the outcomes of cataract and refractive surgeries (EUREQUO). ESCRS continues to support this Registry and has currently a database of over 2,000,000 surgeries.
ESCRS proposes to extend this platform to create a registry of corneal transplantation surgeries in Europe. The European Cornea and Cell Transplantation Network (ECCTR) will link three existing registries and recruit additional centres of excellence and eye banks to contribute data on availability of corneal tissue, methods of transplantation, and visual outcomes of surgery.
The focus of our consortium is on bringing added value and making a positive impact on one of the priority actions set out in the annual Work Programme for 2015; contributing to the fourth overall objective:” To build a common assessment methodology to allow academics, health professionals and authorities to assess and verify safety, quality and efficacy of (new) transplantation therapies and/or other types of clinical applications of human tissues and cells (e.g. assisted reproductive technologies).”
After the completion of this action the ECCTR will have all the data necessary to develop European Guidelines for Corneal Transplant Surgery to better utilise scarce cornea tissue ensure European self-sufficiency and reduce patient waiting lists.

Disease of the cornea (the transparent layer covering the front of the eye) is the second cause of blindness worldwide.
The cornea is the most frequently transplanted intact tissue with over 180,000 transplants performed today. In Europe an estimated 30,000 corneal transplants are performed each year. Currently there is no harmonisation of information across the European Union on the numbers or origins of the scarce corneas tissue available for transplant, the optimum procedure for transplant and the visual outcome and quality of life of corneal transplant patients.
The ESCRS in 2006 with the support of the Executive Agency for Health and Consumers pioneered an online Quality Registry of the outcomes of cataract and refractive surgeries (EUREQUO). ESCRS continues to support this Registry and has currently a database of over 2,500,000 surgeries.
The European Cornea and Cell Transplantation Network (ECCTR) will link three existing
registries and recruit additional centres of excellence and eye banks to contribute data on availability of corneal tissue, methods of transplantation, and visual outcomes of surgery. The focus of our consortium is on bringing added value and making a positive impact on one of the priority actions set out in the annual Work Programme for 2015; contributing to the fourth overall objective:” To build a common assessment methodology to allow academics, health professionals and authorities to assess and verify safety, quality and efficacy of (new) transplantation therapies and/ or other types of clinical applications of human tissues and cells (e.g. assisted reproductive technologies).”After the completion of this action the ECCTR will have all the data necessary to develop European Guidelines for Corneal and Cell Transplant Surgery to better utilise scarce cornea tissue ensure European self-sufficiency and reduce patient waiting lists.

The core methodology for development of a common European platform, ECCTR will consist of collection, storage and analysis of data and dissemination of analysis across European States.

The methods proposed below are based on successful currently existing methodology of the ESCRS funded European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO). This project initially co-funded by the European Union under the Executive Agency for Health and Consumers and now funded by the ESCRS and sustainably running for more than seven years.

Evaluation of variables for the European platform
The development of the European Cornea & Stem Cell Ophthalmic Transplantation Registry will harmonize existing information systems across Europe and will establish a new European platform. A pool of experts from partner organizations will evaluate existing registers and recommend a model for a European-wide platform with the aim to establish a common assessment methodology, develop benchmarks, promote development of best practice guidelines, and determine need and supply of tissues across Europe. This will be accomplished by the convening of a Steering Committee of experts in the field from the partner organizations who will meet in Month 1-4.

Data collection
Forms for data collection will be developed taking into consideration data already existing in partner registers and selecting indicators for the system. An Electronic Data Capturing (EDC) platform will be developed.
The system will record data related to both donor and recipient. Data related to donor tissue will be obtained from participating eye banks. Patient related information, including preoperative, preoperative and postoperative data will be collected by participating clinics and universities. Data recorded will include relevant information at the time of surgery, baseline patient information, including preoperative visual status, the indication for transplantation, the primary reason for transplantation (to improve vision or for other reasons), the presence of risk factors likely to influence the graft outcome the supplying eye bank and the donor cornea reference number, and a patient questionnaire. Follow-up data will be provided after two years when it is likely that all sutures have been removed, refractive surgery (where appropriate) performed, and stable refraction achieved. Post-operative complications, visual acuity and astigmatism will be recorded.

Validation of Patient-Reported Outcome Measures (PROM’s)
Currently, patient-reported outcome measures (PROMs) are less widespread than objective measurements such as visual acuity or refractive error. Implementing PROM’s in routine clinical practice has become a priority of clinical investigators as in addition to providing comprehensive evaluation of the safety and efficacy of these treatments it also provides information on patients quality of life before and after surgery. For this reason PROM’s for corneal transplantation will be developed and validated as a novel tool to be included in the database. PROM’s developed by ESCRS for assessing quality of life after cataract and refractive surgery are currently being tested in six European languages. Building on this experience and lessons learned PROM’s will be developed for corneal transplant surgery. Patients will be given access to online questionnaires that they complete in the doctor’s office before surgery and online after completed surgery.

Validity of Data
Data entry will be regulated by the coding guidelines, which require that data is collected on all consecutive cases during the agreed time period, not just selected cases. An electronic reminder system will be set up to reduce the number of cases lost to follow-up. The forms will be filled in by selecting from a menu of categories or numeric values; there will be no option to enter free text or numbers. An audit committee will periodically validate data captured.

Data output

- The first four months of the project the Steering Committee focused on the development of a common assessment methodology for corneal transplantations.
- Each partner provided the coding guidelines and parameters of the Registry existing in Sweden, Netherlands and England.
- Prof Mats Lundstrom initiated a master document that indicated the necessary information needed about donor cornea, the recipient, the surgery and follow up data.
- The mapping of the three existing EU registries by assessing the existing parameters contained in each European Registries concerning patients, donor, transplant, surgery and eye details have been assessed and discussed in details by the ECCTR Steering Committee
- The ECCTR Steering Committee members through e-mails and meetings decided the process of establishing a model for the EU web-based registry that will allow to establish a common assessment methodology, develop benchmarks, promote development of best practice guidelines, and determine need and supply of tissues across Europe.
- The ECCTR workflow starts with:
- Patient – I.1 Identify Patient I.2 Review/enter Patient details
- Donor – II.1 Identify Donor II.2 Review/enter Donor details
- Tissue .– III.1 Identify Tissue III.2 Review/enter Tissue details
- Surgery – IV Surgery details
- Eye details – V Eye details
- Follow up details – Collect follow up details
- Graft failure details – Collect graft failure data
- The Pilot Database Guidelines (M4) has been developed and contains details concerning the software functionality, follow up and patient reported outcomes.
- The graft failure and immune reactions core pilot data set has been included in the software parameters.
- The prototype databased was ready to be tested by month 12 and the EU web-based registry is linked to the ECCTR web-site.
- The partner FBOV/EEBA has been recruited clinics willing to participate and collect surgeries in the system across Europe
- The system is live and clinics are ready to start to collect surgeries in the system.
- ECCTR has been liaising with the EU funded projects EuroGTPII and VISTART. The SEC and donor parameters have been included in ECCTR following the request of VISTART and EU.

The main objective during this time frame of the project focused on the development, test and roll out of the EU-web based registry across Europe.

The main outputs up-to date are as follow:

1)All ECCTR Partners have agreed on the definitions of the EU web-based registry concerning dataset and functionality in order to build a common assessment methodology for assessing and verify the safety, quality and efficacy of corneal transplantation.
2)The IT provider developed the software for the EU web-based registry under the specifications provided by the ECCTR Steering Committee.
3)The system has been tested few times by all partners and few clinic’s before being rolled out.
4)EEBA recruited 21 clinics across Europe that wished to record their surgeries in the system
5)ECCTR has been promoted during the international medical congresses of the ESCRS, EuCornea and EEBA.

The main target groups informed about ECCTR during the first 18 months of implementation of the project are ophthalmic corneal surgeons.

Once the collection of surgeries will start, the project will have a positive impact and add value in the exchange of information in cornea transplantation across specialists and academics across Europe.

The ECCTR partners have been attending and gave presentations and updates the about the ECCTR project milestones the audience at the Competent Authorities meeting organised by the EU.

The project leaders of ECCTR, GTPII and VISTART exchanged information about the objectives and milestones of the projects and possible synergies amongst work packages. Furthermore it was agreed to develop a joint newsletter that has been sent to all NCAs and stakeholders informing about the development and milestones of these projects funded by the EU.

Overall the activities of the project are proceeding according to the workplan established, as the Eu web-based registry has been developed, tested and clinics have been recruited for the start of collecting transplantations in the system.

During this first year of activities, ECCTR has been involved in a major marketing campaign to encourage surgeons to enrol in the project and to explain the benefits of monitoring and comparing results confidentially with colleagues.

The pre-registration process for surgeons interested in participating in ECCTR has already started. There are two ways of registering, one is the on line form by filling the expression of interest at the ECCTR web-site or paper forms are available at congresses with ECCTR participation.
Podium presentations of ECCTR have been organised at the ESCRS, EuCornea and EEBA congresses

1) 7th EuCornea Congress. 9-10 September in Bella Center, Copenhagen, Denmark. Launch of ECCTR during the Opening Ceremony
2) XXXIV Congress of the ESCRS. 10-14 September Copenhagen, Denmark. Launch of ECCTR during the Opening Ceremony Annual
3) XXIX Annual EEBA Meeting in Prague 2017
G. Jones - European Quality Register for Corneal Grafting
4) 8th EuCornea Congress Friday 6-7 October 2017, Lisbon
M. Dickman - European registry for quality improvement in corneal transplantation surgery
5) XXXV Congress of the ESCRS 7-11 October 2017, Lisbon
M. Dickman - European registry for quality improvement in corneal transplantation surgery
6) XXXV Congress of the ESCRS 7-11 October 2017, Lisbon
M. Lundstrom, M. Dickman Instructional Course: Using the European Cornea and Cell Transplant Registry (ECCTR) for clinical improvement

The ECCTR web-site has been developed and contains information related to the project including objectives, activities and timeframe, participating partners. The web-site is updated on a regular basis as the main source of information is the web-site.

Partners will be keeping promoting the project and disseminate results during international medical congresses. The final report guidelines will be disseminated to a wider audience through the organisation of the final conference