The Dry Eye Zone

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Abstract: Autologous serum in Germany

This is just covering a survey of practices in Germany, discussing issues with regulatory compliance among other things, and does not touch on clinical results. There were no complications reported amongst the group surveyed in 2007... however, with a 55% response rate, I don't know what that means. Anyway, clearly there are motivated people out there trying to get this treatment modality better accepted and more available.

[On the use of autologous serum eyedrops in Germany : Results of a survey among members of the Cornea Section of the German Ophthalmological Society (DOG).][Article in German]
2008 Jul;105(7):644-9.
Kasper K, Godenschweger L, Hartwig D, Unterlauft JD, Seitz B, Geerling G

PURPOSE: The use of serum eye drops has become more common for treating ocular surface diseases such as persistent epithelial defect and dry eye. For the production and use of blood products, regulatory restrictions apply. We surveyed the practice of production and application of serum eyedrops among the members of the Cornea Section of the German Ophthalmological Society (DOG) in Germany.

METHODS: A questionnaire concerning the application of topical blood-derived therapeutic agents for use in the eye was sent to 103 institutions in 2005 and 2007. The questionnaire included 14 groups of questions.

RESULTS: The rate of response was 49% in 2005 and 55% in 2007. Sixty-five percent (2005: 48%) of the institutions used blood-derived products as therapeutic agents in the eye (in 96%, serum eye drops). In 2007, 17% of the centers stated that they had a license to produce serum eye drops according to the official regulations (2005: 10%). Three hospitals stopped using serum eyedrops for regulatory reasons. In 2007 1,237 patients were treated (2005: 1,389); 36% of the ophthalmic departments produced the serum eye drops themselves (2005: 55%) and 43% produced them in cooperation together with or exclusively in another institution. Quality controls (e.g., virus serology and sterility checks) were performed in 47% (2005: 24%). In 2005, one corneal fibrin deposit was described. In 2007, no complication was reported.

CONCLUSION: Although fewer patients were treated in total in 2007, the number of centers using serum eye drops increased between 2005 and 2007. Serious complications were not described. Some hospitals stopped the production and use of serum eye drops because of regulatory reasons or had the drops produced by nonophthalmic institutions with a license to produce blood-derived products. In view of prospective randomized clinical trials showing that autologous serum support ocular surface wound healing, this therapy should be accepted as a standard of care.

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