Abstract
Purpose According to German and European legislation, the production of blood products such as autologous serum eye drops (ASED) requires a license from an appropriate authority. An exemption is granted to medical doctors who produce and apply medications under their immediate responsibility, allowing hospital-affiliated eye banks to produce ASED for in-house use. The aim of this study was to compare corneal healing of epithelial defects (erosions and ulcers) on the corneal graft after penetrating keratoplasty (PKP) in comparison with the patient‘s own cornea after treatment with undiluted ASED from our in-site eye bank.
Methods In this retrospective study, we analysed 263 eyes treated with ASED for persistent corneal epithelial defects. ASED were produced by our LIONS Eye Bank Saar-Lor-Lux, Trier/Westpfalz for hospital use or by our Institute for transfusion medicine for subsequently outpatient use. We compared the epithelial healing tendency and erosion recurrence rate of patients with defects on their own cornea (51.9%) vs. patients who had previously undergone PKP (48.1%). An epithelial healing within the 28 first days of therapy was considered as therapeutic success.
Results Therapeutic success was observed in 88.2% of the eyes. There was no significant difference with respect to success rate between corneal defects on the patient‘s own cornea (87.8%) and on the graft (88.6%; p = 0.137). There was a significantly lower success rate for corneal ulcers (74.2%) than for erosions (90.3%; p < 0.001). The recurrence rate was 4,4% for erosions vs. 4.3% in ulcers during follow-up. We do not observe any complications related to ASED therapy.
Conclusions ASED seems to be safe and valuable alternative treatment for persistent corneal epithelial defects, also in case of wound healing disorder after PKP. ASED can be produced in eye banks (for hospital use only) in accordance with the European and German legislation. The success rate, but not the recurrence rate, is significantly worse in ulcers than in erosions.
