TY - JOUR T1 - Improving the practicality and safety of artificial corneas: Pre-assembly and gamma-rays sterilization of the Boston Keratoprosthesis JF - The Ocular Surface Y1 - 2018 A1 - Gonzalez-Andrades, Miguel A1 - Sharifi, Roholah A1 - Islam, Mohammad Mirazul A1 - Divoux, Thibaut A1 - Haist, Michael A1 - Paschalis, Eleftherios I. A1 - Gelfand, Larisa A1 - Mamodaly, Shamina A1 - Di Cecilia, Luca A1 - Cruzat, Andrea A1 - Franz-Josef Ulm A1 - Chodosh, James A1 - Delori, Francois A1 - Dohlman, Claes H. KW - Artificial corneas; Boston keratoprosthesis; Gamma radiation; Gamma rays; Preassembly; Sterilization; Polymethyl methacrylate AB -

Purpose: To make the Boston keratoprosthesis (B-KPro), together with its carrier corneal graft, more easily procured, transported and stored, as well as less expensive, easier for the surgeon to implant and safer for the patient, it is proposed that the B-KPro-graft combination be pre-assembled by an expert technician, followed by sterilization with gamma ray irradiation (GI) allowing long-term storage at room temperature. For this to be possible, it must be shown that the B-KPro itself (not only the graft) remains unharmed by the irradiation.

Methods: Polymethyl methacrylate (PMMA) discs and B-KPros were submitted to either ethylene oxide sterilization or different doses of GI. Cell biocompatibility, mechanical strength and optical quality were evaluated. The feasibility of assembling the B-KPro to a corneal graft, and gamma-radiate afterwards, was also assessed.

Results: There were no differences in cell biocompatibility between the samples. The optical evaluation showed high levels of transparency for all the groups. The absorbance of ultraviolet was higher for the groups treated with GI. The mechanical evaluation by nanoindentation showed no alterations of the PMMA discs after GI. The flexure test revealed a similar mechanical behavior. Technically, pre-assembly and GI of the B-KPro revealed no problems.

Conclusions: Sterilization of B-KPro using GI has no detrimental influence on the device. The pre-assembly of B-KPro to a donor cornea, followed by gamma sterilization, emerges as an efficient and safe procedure. (C) 2018 Elsevier Inc. All rights reserved.

VL - 16 UR - https://linkinghub.elsevier.com/retrieve/pii/S1542012418300442 IS - 3 JO - The Ocular Surface ER -