The project aims to build a common assessment methodology and establish an EU web-based registry and network for academics, health professionals and authorities to assess and verify the safety quality and efficacy of corneal transplantation.
The consortium of the project consists of eight partners: the European Society of Cataract and Refractive Surgeons (ESCRS), European Society of Cornea and Ocular Surface Disease Specialists (EuCornea), Fondazione Banca degli Occhi del Veneto Onlus (FBOV) & European Eye Bank Association (EEBA), NHS Blood and Transplant (NHSBT), University of Maastricht (MU), Nederlandse Transplantatie Stichting (NTS) and Blekinge Lans Landsting (LTBlekinge).
The project is a three year programme, made up of development of an EU web-based registry in the first year, recruitment of clinics and eye banks and collection of data in year two, evaluation of the data collected and development of a evidence based European control and dissemination of results at a final conference in year three
- To develop and test an EU web-based registry, for assessing and verifying the safety quality and efficacy of human donor tissue transplantations in ophthalmology.
- To roll out the system across Europe, involving eye banks and clinics in the collection of data and establishing interfaces with the existing registries in Europe. Promote registry at European level and encourage participation by all European transplant centres
- To analyse the safety, quality and efficacy of ophthalmic donor tissue transplantations, including a novel tool for patient reported outcomes.
- Strengthen the knowledge concerning adverse immune reactions through active cooperation with EU funded projects Arrest Blindness and VISICORT on the definition and validation of parameters for clinical application within the European Cornea and Cell Transplantation Registry
- To collect data on the need and availability of human donor tissue for transplantation in Europe to allow academics, health care professionals and authorities to optimize scarce donor tissue allocation
- To provide a pan-European overview of current clinical practice to support development of benchmarks and guidelines regarding the safety, quality and efficacy of ophthalmic transplantation therapies.
- To disseminate the results of the evidence based European protocol on the benefits to researchers, professional practitioners, competent authorities and the wider community.
- Development of key objective performance indicators to increase quality of corneal transplant surgeries
- Validation of patient related outcome measures (PROMs)
- Harmonization of the three existing partner registries
- Propose a minimal standard protocol for a EU registry
- Establish an Electronic Data Capture (EDC) system and rolling the EU registry
- Define the set of quality indicators and parameters that are important for quality control and quality improvement in the field
- Develop evidence based guidelines for good clinical practice, particularly with regard to safety, quality and efficacy
- Strengthen cooperation between EU Member States competent Health authorities
- Define significant adverse events related to corneal transplantation in collaboration
- Develop innovative benchmarks taking into account patient related outcomes which will enable health care practitioners to better inform patients about expected outcomes
- Provide information on the number and type of transplantations performed in Europe and the origin of donor tissue including import and export between European countries and third parties in collaboration with EUROCET
- Create and facilitate a European network of practitioners and stakeholders by raising awareness to the project and its outcomes across Europe
- Analyze implementation by measuring data completeness and follow up rates
Time frame Work Packages
The core work packages will be implemented with the following time schedule
- WP 1- Coordination May 2016 – May 2019
- WP 2- Dissemination August 2016 – May 2019
- WP 3 – Monitoring Evaluation May 2016 – May 2019
- WP 4 – Development of the software for the common Europe-wide platform May 2016 – May 2019
- WP 5 –Active clinical cooperation and networking with VISICORT May 2016-May 2019
- WP 6 – Data collection recruitment of clinics across Europe May 2017-May 2019
- WP 7 – Evaluation of data collected & development of an evidence based European protocol May 2016 – May 2019