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Fernández Bueno, Iván Olcina, Luis Ignacio Andrés Iglesias, Cristina Puertas Neyra, Kevin Louis Fernández Martínez, Itziar Usategui Martín, Ricardo Maldonado López, Miguel José 2023-09-12T07:13:15Z 2023-09-12T07:13:15Z 2023 Heliyon, 2023, vol. 9, issue 9, e19604 2405-8440 https://uvadoc.uva.es/handle/10324/61520 10.1016/j.heliyon.2023.e19604 e19604 9 Heliyon 9 Producción Científica This study aims to evaluate the safety, biocompatibility, and functionality of a new accommodative intraocular lens (IOL) (LUZ, patent PCT/ES2016/070,813) after implantation in rabbit eyes. LUZ (Study) and EyeCee® plus a capsular ring (Control) were implanted in rabbits (n = 8 each) after phacoemulsification. Intraoperative follow-up, long-term clinical follow-up, and functional IOL studies were carried out periodically for up to 180 days. A macroscopic examination of the eyeballs to reveal abnormalities and determine the implant centering and a microscopic examination to semi-quantify cell and tissue response were performed. Statistical analysis of the collected data was finally achieved. During follow-up, no significant changes in the general condition nor the clinical evaluation were observed between both groups. However, Study IOL remained centered throughout the study and did not present severe complications as observed in the Control group. Functional studies did not reveal significant differences between both materials. Study showed better centering, fewer adhesions, and maintenance of an opening capsular bag compared to the Control. Local biological effects caused by Study implantation are minimal and comparable to the Control. Therefore, LUZ showed no clinical signs or histological response of adverse reaction to the implanted material, according to UNE-EN ISO 11979-5 and 10993-6. Functionality must be confirmed in another animal species with greater lens accommodation capacity than the rabbit. LUZ keeps the capsular bag open, favoring its centering and avoiding fibrosis and adherence to the bag; this allows potential accommodation of this IOL and theoretically enables the patient to focus dynamically. Ministerio de Ciencia e Innovación (Neotec Project EXP-00104711/SNEO-20171172) application/pdf eng Elsevier info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by-nc-nd/4.0/ © 2023 The Authors Attribution-NonCommercial-NoDerivatives 4.0 Internacional Eye Diseases Oftalmología Presbyopia Intraocular lens Biocompatibility Presbicia Lente intraocular Biocompatibilidad 3201.09 Oftalmología Safety, biocompatibility, and potential functionality of a new accommodative intraocular lens: An experimental study in rabbits info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion https://www.sciencedirect.com/science/article/pii/S2405844023068123?via%3Dihub SI