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Safety and efficacy of a novel hydrophobic acrylic IOL – iPure: a randomized study

Session Details

Session Title: New IOLs

Session Date/Time: Tuesday 08/10/2013 | 16:30-18:15

Paper Time: 16:54

Venue: Elicium 1 (First Floor)

First Author: : S.Maedel AUSTRIA

Co Author(s): :    N. Hirnschall   M. Weber   P. Draschl   J. Wiesinger   O. Findl  

Abstract Details

Purpose:

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.

Setting:

Vienna Institute for Research in Ocular Surgery, Department of Ophthalmology, Hanusch Hospital, Vienna.

Methods:

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 performed 1 month and 1 year post-operatively. Additionally, slitlamp examination with subjective grading of glistenings (0=none, 1=mild, 2=moderate, 3=severe) and retroillumination photography for PCO grading were performed 1 hour, 1 month and 1 year post-operatively.

Results:

Preliminary results include data of 45 eyes of 45 patients with a mean age of 69 years at the 1 month postOP follow-up. In 22 eyes, the new iPure IOL was implanted compared to 23 eyes with the control IOL. Mean (SD) target refraction for the iPure and the control IOL was -0.58 D (0.70) and -0.35 (0.28), respectively. 1 month post-operatively, mean (SD) absolute difference between subjective spherical refraction and target refraction for the iPure and the control IOL was 0.54 D (0.41) and 0.49 D (0.36) (p t-test= 0.67). Mean (SD) UCVA was similar for both groups with 0.17 logMAR (0.25) and 0.14 logMAR (0.16) (p t-test= 0.60). 1 month post-operatively, in the iPure and control group mild glistenings were found in 3 (14 %) and 2 (9%) cases, respectively.

Conclusions:

The novel iPure IOL is made of a newly developed hydrophobic material designed to avoid formation of glistenings. Similar to comparable foldable acrylic IOLs, its open-loop haptic design together with a 360° sharp optic edge are designed to prevent PCO formation and to improve intracapsular stability. Early results reveal a good optic performance compared to a gold standard acrylic IOL. One month postoperatively, subjective refractive outcome and UCVA were satisfying and did not differ significantly between the groups. There were only few cases of low amount of glistenings with both IOLs at this early postoperative phase. However, analysis of the complete dataset and results of 1 year-postOP follow-ups need to be awaited to compare long-term IOL safety, especially concerning formation of glistenings and PCO.

Financial Interest:

NONE