Prospective comparative fellow-eye clinical trial to evaluate the axial position stability of CT LUCIA 611P and CT ASPHINA 409MP IOLs

Session Details

Session Title: Monofocal IOLs: New Biomaterials & Visual Performance

Session Date/Time: Tuesday 17/09/2019 | 16:30-18:00

Paper Time: 17:48

Venue: Free Paper Forum: Podium 2

First Author: : J.Hienert AUSTRIA

Co Author(s): :    N. Hirnschall   C. Pilwachs   M. Ruiss   K. Kefer   B. Döller   O. Findl              

Abstract Details

Purpose:

Axial IOL position stability of the C-loop CT LUCIA 611P IOL in comparison with the four point haptic IOL CT ASPHINA 409MP after implantation.

Setting:

Hanusch Hospital Vienna

Methods:

In the prospective fellow-eye study 100 eyes of 50 patients were included. CT LUCIA 611P and CT ASPHINA 409MP (Carl Zeiss Meditec) were implanted in all study patients. The IOL implanted in each eye was chosen in a randomised manner. One inclusion criterion was a distance corrected visual acuity (CDVA) of ≤0.3logMAR. Pre-operative and post-operative examinations at 1 week (W1), 1 month (M1) and 4-6 months (M4-6) included monocular uncorrected distance visual acuity (UDVA) and CDVA and anterior chamber depth (ACD) measurements. Also, tilt, decentration and safety parameters were evaluated postoperatively at W1, M1 and M4-6.

Results:

Until now 1 month data for all patient have been evaluated. UDVA at M1: 0.08+-0.14logMAR for CT LUCIA-611P and 0.04±0.09logMAR for CT ASPHINA-409MP. CDVA at M1: -0.01+-0.10logMAR for CT LUCIA-611P and -0.03+-0.08logMAR for CT ASPHINA-409MP. The mean preoperative ACD was 3.14+-0.37mm and 3.18+-0.37mm for CT LUCIA-611P and for CT ASPHINA-409MP, respectively. Postoperatively, following CT LUCIA-611P implantation in 48 eyes, the mean baseline ACD at W1 was 5.47+-0.64mm and 5.74+-0.53mm at M1. Following CT ASPHINA-409MP implantation in 48 eyes, the mean baseline ACD at W1 was 4.42+-0.46mm and at M1 was 4.61+-0.39mm.

Conclusions:

The M1 interim results show an excellent outcome regardless of the implanted IOL. All patients are included in the study and underwent their last visit. It is planned to present final data (M4-6) at the meeting. The main outcome of the study is the evaluation of axial IOL position stability of these two very different types of IOLs.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented