RT info:eu-repo/semantics/article
T1 Safety, biocompatibility, and potential functionality of a new accommodative intraocular lens: An experimental study in rabbits
A1 Fernández Bueno, Iván
A1 Olcina, Luis Ignacio
A1 Andrés Iglesias, Cristina
A1 Puertas Neyra, Kevin Louis
A1 Fernández Martínez, Itziar
A1 Usategui Martín, Ricardo
A1 Maldonado López, Miguel José
K1 Eye Diseases
K1 Oftalmología
K1 Presbyopia
K1 Intraocular lens
K1 Biocompatibility
K1 Presbicia
K1 Lente intraocular
K1 Biocompatibilidad
K1 3201.09 Oftalmología
AB 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.
PB Elsevier
SN 2405-8440
YR 2023
FD 2023
LK https://uvadoc.uva.es/handle/10324/61520
UL https://uvadoc.uva.es/handle/10324/61520
LA eng
NO Heliyon, 2023, vol. 9, issue 9, e19604
NO Producción Científica
DS UVaDOC
RD 24-nov-2024