Miguel Gonzalez-Andrades1, Roholah Sharifi2, Mohammad Mirazul Islam2, Thibaut Divoux3, Michael Haist4, Eleftherios I Paschalis2, Larisa Gelfand2, Shamina Mamodaly2, Luca Di Cecilia2, Andrea Cruzat5, Franz-Josef Ulm6, James Chodosh2, Francois Delori2, Claes H Dohlman2. 1. Massachusetts Eye and Ear and Schepens Eye Research Institute, Department of Ophthalmology, Harvard Medical School, Boston, MA, United States. Electronic address: miguel_gonzalez@meei.harvard.edu. 2. Massachusetts Eye and Ear and Schepens Eye Research Institute, Department of Ophthalmology, Harvard Medical School, Boston, MA, United States. 3. Centre de Recherche Paul Pascal, CNRS UMR, 5031, Pessac, France; MultiScale Material Science for Energy and Environment, UMI 3466, CNRS-MIT, Cambridge, MA, United States. 4. Institute of Concrete Structures and Building Materials, Karlsruhe Institute of Technology, Karlsruhe, Germany; Massachusetts Institute of Technology, Department of Civil and Environmental Engineering, Cambridge, MA, United States. 5. Massachusetts Eye and Ear and Schepens Eye Research Institute, Department of Ophthalmology, Harvard Medical School, Boston, MA, United States; Ophthalmology Department, Pontificia Universidad Católica de Chile, Santiago, Chile. 6. Massachusetts Institute of Technology, Department of Civil and Environmental Engineering, Cambridge, MA, United States.
Abstract
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.
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.
Authors: Mohammad Mirazul Islam; Roholah Sharifi; Shamina Mamodaly; Rakibul Islam; Daniel Nahra; Dina B Abusamra; Pui Chuen Hui; Yashar Adibnia; Mehdi Goulamaly; Eleftherios I Paschalis; Andrea Cruzat; Jing Kong; Per H Nilsson; Pablo Argüeso; Tom Eirik Mollnes; James Chodosh; Claes H Dohlman; Miguel Gonzalez-Andrades Journal: Acta Biomater Date: 2019-07-05 Impact factor: 8.947
Authors: Sina Sharifi; Mohammad Mirazul Islam; Hannah Sharifi; Rakibul Islam; Tahmida N Huq; Per H Nilsson; Tom E Mollnes; Khoa D Tran; Corrina Patzer; Claes H Dohlman; Hirak K Patra; Eleftherios I Paschalis; Miguel Gonzalez-Andrades; James Chodosh Journal: Macromol Biosci Date: 2021-02-24 Impact factor: 4.979
Authors: Sina Sharifi; Hannah Sharifi; Curtis Guild; Mohammad Mirazul Islam; Khoa D Tran; Corrina Patzer; Claes H Dohlman; Eleftherios I Paschalis; Miguel Gonzalez-Andrades; James Chodosh Journal: Ocul Surf Date: 2021-03-03 Impact factor: 5.033
Authors: Sina Sharifi; Mohammad Mirazul Islam; Hannah Sharifi; Rakibul Islam; Per H Nilsson; Claes H Dohlman; Tom Eirik Mollnes; Eleftherios I Paschalis; James Chodosh Journal: Transl Vis Sci Technol Date: 2020-12-23 Impact factor: 3.283
Authors: Sina Sharifi; Mohammad Mirazul Islam; Hannah Sharifi; Rakibul Islam; Darrell Koza; Felisa Reyes-Ortega; David Alba-Molina; Per H Nilsson; Claes H Dohlman; Tom Eirik Mollnes; James Chodosh; Miguel Gonzalez-Andrades Journal: Bioact Mater Date: 2021-04-17
Authors: Mohammad Mirazul Islam; Dina B AbuSamra; Alexandru Chivu; Pablo Argüeso; Claes H Dohlman; Hirak K Patra; James Chodosh; Miguel González-Andrades Journal: Pharmaceutics Date: 2021-06-03 Impact factor: 6.321