Safety and efficacy of a novel hydrophobic acrylic IOL - iPure: a randomized study
First Author: SophieMaedel AUSTRIA
Co Author(s): Nino Hirnschall Maria Weber Petra Draschl Joerg Wiesinger Oliver Findl
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To assess the efficacy of a new hydrophobic acrylic IOL concerning visual outcome, glistenings, posterior capsule opacification (PCO), and intracapsular stability after implantation during cataract surgery.
: Vienna Institute for Research in Ocular Surgery, Department of Ophthalmology, Hanusch Hospital, Vienna, Austria
Fifty eyes of 50 patients were included in this randomized, controlled and patient- and investigator-masked study. Standard cataract surgery with phacoemulsification and irrigation/aspiration of cortical material was performed. The IOL to be implanted was allocated by randomization. Either the new hydrophobic acrylic IOL (iPure, PhysIOL, Belgium) or the hydrophobic acrylic control IOL (Tecnis ZCB00, AMO, USA) was implanted. In all eyes, subjective refraction, UCVA and BCVA were assessed. Additionally, slitlamp examination with subjective grading of glistenings (0=none to 3=severe), retroillumination photos and PCO AQUA score were performed 1 hour, 1 month and 1 year postOP.
Preliminary results include data of 47 eyes of 47 patients with a mean age of 69 years at 1 month postOP. In 22 eyes, the new iPure IOL was implanted compared to 25 eyes with the control IOL. One month post-operatively, mean (SD) absolute difference between subjective spherical refraction and target refraction for the iPure and the control IOL was 0.58 D (0.39) and 0.34 D (0.21) (p>0.05). Mean (SD) UCVA was similar for both groups with 0.10 (0.16) and 0.06 logMAR (0.08) (p>0.05).
Early results reveal good optical performance of the novel iPure IOL compared to the control acrylic IOL. One month postOP, refraction and UCVA were satisfying and did not differ significantly between the groups. However, to compare long-term safety, especially concerning glistenings and PCO, 1 year results need to be awaited. FINANCIAL INTEREST: NONE