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

Session Details

Session Title: IOL Power Calculations, Post-LASIK & Extreme Eyes

Session Date/Time: Tuesday 25/09/2018 | 14:00-16:00

Paper Time: 14:38

Venue: Room A2

First Author: : J.Hienert AUSTRIA

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

Abstract Details

Purpose:

To assess the axial IOL position stability of the C-loop CT LUCIA 611P IOL compared to the CT ASPHINA 409MP four point haptic IOL.

Setting:

Hanusch Hospital Vienna

Methods:

In a prospective study, 100 eyes of 50 patients underwent cataract surgery with implantation of CT LUCIA 611P or CT ASPHINA 409MP (Carl Zeiss Meditec) in a randomised fashion. The mean age of the patients was 73±7.9 years. Inclusion criteria included distance corrected visual acuity (CDVA) of ≤0.3logMAR. Pre-operative and post-operative examinations at 1 week (W1), one month (M1) and 4-6 months (M4-6) included monocular uncorrected distance visual acuity (UDVA) and DVCA and anterior chamber depth (ACD) measurements. Tilt and decentration, safety parameters and axial position will be evaluated postoperatively at W1, M1 and M4-6.

Results:

Data for 40 eyes at one month follow-up are presented. Preoperative UDVA was 0.41±0.21logMAR and CDVA was 0.22±0.10logMAR. UDVA at M1: 0.05±0.13logMAR for CT LUCIA 611P and 0.05±0.14logMAR for CT ASPHINA 409MP. Monofocal CDVA at M1 for CT LUCIA 611P was 0.04±0.09logMAR and for CT ASPHINA 409MP was 0.035±0.09logMAR. The mean preoperative ACD was 3.25±0.36mm with no statistical difference between fellow eyes. The mean baseline (W1) ACD was 5.07±0.73mm and 4.94±0.77mm and the mean ACD at M1 was 5.15±0.65mm and 5.03±0.65mm for 20 eyes implanted with either CT LUCIA 611P or CT ASPHINA 409MP, respectively.

Conclusions:

This fellow-eye study evaluates the outcomes of two IOLs that differ in haptic design as well as material. The final study will include 100 eyes with a follow-up period of M4-6. In a subset of eyes, monocular measurements of the performance of CT ASPHINA 409MP and CT LUCIA 611P at W1 and M1 demonstrate excellent outcomes regardless of the IOL implanted. The main outcome of the study is the evaluation of axial IOL position stability of these two geometrically distinct monofocal IOLs. The interim one month results, in particular ACD shift compared to baseline, defined as W1, will be discussed.

Financial Disclosure:

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