Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits
Purpose. To evaluate clinically and histologically the safety and biocompatibility of a new HDPE-based spherical porous orbital implants in rabbits. Methods. MEDPOR (Porex Surgical, Inc., Fairburn, GA, USA), OCULFIT I, and OCULFIT II (AJL Ophthalmic S.A., Vitoria, Spain) implants were implanted in e...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | Journal of Ophthalmology |
| Online Access: | http://dx.doi.org/10.1155/2015/904096 |
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| author | Ivan Fernandez-Bueno Salvatore Di Lauro Ivan Alvarez Jose Carlos Lopez Maria Teresa Garcia-Gutierrez Itziar Fernandez Eva Larra Jose Carlos Pastor |
| author_facet | Ivan Fernandez-Bueno Salvatore Di Lauro Ivan Alvarez Jose Carlos Lopez Maria Teresa Garcia-Gutierrez Itziar Fernandez Eva Larra Jose Carlos Pastor |
| author_sort | Ivan Fernandez-Bueno |
| collection | DOAJ |
| description | Purpose. To evaluate clinically and histologically the safety and biocompatibility of a new HDPE-based spherical porous orbital implants in rabbits. Methods. MEDPOR (Porex Surgical, Inc., Fairburn, GA, USA), OCULFIT I, and OCULFIT II (AJL Ophthalmic S.A., Vitoria, Spain) implants were implanted in eviscerated rabbis. Animals were randomly divided into 6 groups (n=4 each) according to the 3 implant materials tested and 2 follow-up times of 90 or 180 days. Signs of regional pain and presence of eyelid swelling, conjunctival hyperemia, and amount of exudate were semiquantitatively evaluated. After animals sacrifice, the implants and surrounding ocular tissues were processed for histological staining and polarized light evaluation. Statistical study was performed by ANOVA and Kaplan-Meier analysis. Results. No statistically significant differences in regional pain, eyelid swelling, or conjunctival hyperemia were shown between implants and/or time points evaluated. However, amount of exudate differed, with OCULFIT I causing the smallest amount. No remarkable clinical complications were observed. Histological findings were similar in all three types of implants and agree with minor inflammatory response. Conclusions. OCULFIT ophthalmic tolerance and biocompatibility in rabbits were comparable to the clinically used MEDPOR. Clinical studies are needed to determine if OCULFIT is superior to the orbital implants commercially available. |
| format | Article |
| id | doaj-art-402aed6331d4447ca1b1898ffd329bf1 |
| institution | Kabale University |
| issn | 2090-004X 2090-0058 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Ophthalmology |
| spelling | doaj-art-402aed6331d4447ca1b1898ffd329bf12025-08-20T03:55:36ZengWileyJournal of Ophthalmology2090-004X2090-00582015-01-01201510.1155/2015/904096904096Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in RabbitsIvan Fernandez-Bueno0Salvatore Di Lauro1Ivan Alvarez2Jose Carlos Lopez3Maria Teresa Garcia-Gutierrez4Itziar Fernandez5Eva Larra6Jose Carlos Pastor7Instituto Universitario de Oftalmobiologia Aplicada (IOBA), University of Valladolid, 47011 Valladolid, SpainInstituto Universitario de Oftalmobiologia Aplicada (IOBA), University of Valladolid, 47011 Valladolid, SpainAJL Ophthalmic S.A., 01510 Miñano, SpainInstituto Universitario de Oftalmobiologia Aplicada (IOBA), University of Valladolid, 47011 Valladolid, SpainInstituto Universitario de Oftalmobiologia Aplicada (IOBA), University of Valladolid, 47011 Valladolid, SpainInstituto Universitario de Oftalmobiologia Aplicada (IOBA), University of Valladolid, 47011 Valladolid, SpainAJL Ophthalmic S.A., 01510 Miñano, SpainInstituto Universitario de Oftalmobiologia Aplicada (IOBA), University of Valladolid, 47011 Valladolid, SpainPurpose. To evaluate clinically and histologically the safety and biocompatibility of a new HDPE-based spherical porous orbital implants in rabbits. Methods. MEDPOR (Porex Surgical, Inc., Fairburn, GA, USA), OCULFIT I, and OCULFIT II (AJL Ophthalmic S.A., Vitoria, Spain) implants were implanted in eviscerated rabbis. Animals were randomly divided into 6 groups (n=4 each) according to the 3 implant materials tested and 2 follow-up times of 90 or 180 days. Signs of regional pain and presence of eyelid swelling, conjunctival hyperemia, and amount of exudate were semiquantitatively evaluated. After animals sacrifice, the implants and surrounding ocular tissues were processed for histological staining and polarized light evaluation. Statistical study was performed by ANOVA and Kaplan-Meier analysis. Results. No statistically significant differences in regional pain, eyelid swelling, or conjunctival hyperemia were shown between implants and/or time points evaluated. However, amount of exudate differed, with OCULFIT I causing the smallest amount. No remarkable clinical complications were observed. Histological findings were similar in all three types of implants and agree with minor inflammatory response. Conclusions. OCULFIT ophthalmic tolerance and biocompatibility in rabbits were comparable to the clinically used MEDPOR. Clinical studies are needed to determine if OCULFIT is superior to the orbital implants commercially available.http://dx.doi.org/10.1155/2015/904096 |
| spellingShingle | Ivan Fernandez-Bueno Salvatore Di Lauro Ivan Alvarez Jose Carlos Lopez Maria Teresa Garcia-Gutierrez Itziar Fernandez Eva Larra Jose Carlos Pastor Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits Journal of Ophthalmology |
| title | Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits |
| title_full | Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits |
| title_fullStr | Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits |
| title_full_unstemmed | Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits |
| title_short | Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits |
| title_sort | safety and biocompatibility of a new high density polyethylene based spherical integrated porous orbital implant an experimental study in rabbits |
| url | http://dx.doi.org/10.1155/2015/904096 |
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