Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory requirements concerning the manufacture and clinical use of human cornea in Germany ***

Dr. Olga Nilmayer (Abschlußjahr: 2019)

Summary
Language: German
Some eye diseases and cornea blindness can be healed or restored through cornea transplantation. Human cornea can be prepared from donated eyes and cultivated for more than 30 days in special media. This preparation is performed in eye banks - there are more than 20 of them in Germany. The processes of human cornea preparation are described in detail in this master thesis.
To minimize the risk of infections and guarantee high quality of transplants, human cornea production is strongly regulated in Germany by European and German legislations. In this master thesis, the regulatory framework guiding cornea donation, preparation and transplantation is described.
According to the report of German Society of Ophtalmology (DOG), since the year 2001 the number of corneal transplantations has increased 1.5-fold, from 4730 keratoplasties in 2001 to 7325 penetrating keratoplasties in 2016. Techniques of transplanation have been improved and new methods of cornea transplantation have been developed during the last years. Nevertheless, there is a lack of available cornea transplants in Germany. According to the report of DOG, 3575 patients were on so-called waiting lists at the end of 2016. It is estimated that presently there are even more patients waiting for cornea.
The aim of this work was to demonstrate the situation around cornea transplantation in Germany. Different statistics sources were studied for this work. German government reports were analyzed, and possible future course of action was suggested.
Pages: 49