Multicenter clinical trial results of a new one-piece EDOF IOL in cataract patients after bilateral implantation

Session Details

Session Title: Extended Depth-of-Focus IOL Concepts

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:39

Venue: Room A4

First Author: : B.Dick GERMANY

Co Author(s): :    E. Mertens   P. Stodulka   D. Breyer              

Abstract Details

Purpose:

To evaluate clinical outcomes of a one-piece bioanalogic Extended Depth of Focus (EDOF) Wichterle-Continuous Focus intraocular lens (WIOL-CF®, Medicem, CR) without haptics after bilateral implantation using Femtosecond laser-assisted cataract surgery (LCS) in a European cataract population with a follow-up of 6 months postoperatively.

Setting:

University Hospital, Bochum, GER Medipolis Antwerp Private Clinic, Belgium Gemini oční klinika, CR Mendicute, Asociación Instituto BIODONOSTIA, Spain Mazzini, University Hospital, Italy Cadarso, Clínica CADARSO, Spain Tetz, Berlin Eye Research, GER Breyer, International Innovative OC Düsseldorf, GER Holland, nordBLICK Augenklinik Bellevue GmbH, Kiel, GER

Methods:

This prospective, ethics committee-approved, multicenter post marketing clinical follow-up (PMCF) investigation served to assess visual acuity, predictability of refraction, subjective refraction, defocus curve, contrast sensitivity, IOL position, incidence of adverse optical phenomena, spectacle independence, patient expectation, satisfaction, adverse events and device deficiencies in patients who underwent bilateral LCS followed by implantation of the WIOL-CF. Uncorrected distance (UDVA), intermediate (UIVA) and near (UNVA), corrected distance, inter¬mediate, near as well as distance corrected distance, intermediate and near visual acuities (VA) were measured. The primary endpoint was the binocular uncorrected visual acuity.

Results:

The study comprised of a total of 156 patients. Mean (±standard deviation) binocular uncorrected visual acuities in the Full Analysis Set (FAS) and the Per-Protocol Set (PPS) valued as follows: UCDVA 0.028 (±0.098), UCIVA 0.060 (±0.118) and UCNVA 0.209 (±0.146) in FAS, and UCDVA 0.027 (±0.096), UCIVA 0.054 (±0.121) and UCNVA 0.204 (±0.139) in PPS. The mean binocular defocus curve showed an extended depth of focus of approximately 2.5 D. The results after 6 months confirmed a stable and well-centered IOL position.

Conclusions:

This large trial confirmed previous results of investigations with smaller numbers. Bilateral implan¬ta-tion of the EDOF WIOL-CF provided excellent distance and intermediate VA and good near VA while maintaining excellent contrast sensitivity, high patient satisfaction and spectacle inde¬pendence. The WIOL-CF is a novel, effective and reliable surgical solution for the correction of presbyopia.

Financial Disclosure:

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