TY - JOUR

T1 - Improving the practicality and safety of artificial corneas

T2 - Pre-assembly and gamma-rays sterilization of the Boston Keratoprosthesis

AU - Gonzalez-Andrades, Miguel

AU - Sharifi, Roholah

AU - Islam, Mohammad Mirazul

AU - Divoux, Thibaut

AU - Haist, Michael

AU - Paschalis, Eleftherios I.

AU - Gelfand, Larisa

AU - Mamodaly, Shamina

AU - Di Cecilia, Luca

AU - Cruzat, Andrea

AU - Ulm, Franz Josef

AU - Chodosh, James

AU - Delori, Francois

AU - Dohlman, Claes H.

N1 - Funding Information: This paper was supported by Boston-KPro research fund. TD gratefully acknowledges support from the MIT-France seed fund and the CNRS through a PICS-USA scheme (No. 36939 ).

PY - 2018/7

Y1 - 2018/7

N2 - 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.

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.

KW - Artificial corneas

KW - Boston keratoprosthesis

KW - Gamma radiation

KW - Gamma rays

KW - Polymethyl methacrylate

KW - Preassembly

KW - Sterilization

UR - http://www.scopus.com/inward/record.url?scp=85045844407&partnerID=8YFLogxK

U2 - 10.1016/j.jtos.2018.04.002

DO - 10.1016/j.jtos.2018.04.002

M3 - Article

C2 - 29627599

AN - SCOPUS:85045844407

VL - 16

SP - 322

EP - 330

JO - Ocular Surface

JF - Ocular Surface

SN - 1542-0124

IS - 3

ER -