Prospective multicenter trial on outcomes after bilateral implantation of the bioanalogic WIOL-CF IOL
Session Details
Session Title: Moderated Poster Session: The New Enlarged Depth-of-Focus Technology
Venue: Poster Village: Pod 1
First Author: : B.Dick GERMANY
Co Author(s): : E. Mertens P. Stodulka C. Mazzini M. Tetz D. Breyer D. Holland
Abstract Details
Purpose:
To evaluate the clinical outcomes after femtosecond laser-assisted cataract surgery followed by sequential bilateral implantation of the bioanalogic WIOL-CF intraocular lens (WIOL, Medicem), which has an extended depth of focus optical (EDOF) design.
Setting:
University Eye Hospital, Bochum, Germany; Medipolis Private Clinic, Antwerp, Belgium; Gemini oční klinika, Czech Republic; Asociación Instituto BIODONOSTIA, Spain; Careggi University Hospital, Italy; Clínica CADARSO, Spain; Berlin Eye Research Institute, Germany; International Innovative Ophthalmic Surgery, Düsseldorf, Germany; nordBLICK Augenklinik Bellevue, Kiel, Germany
Methods:
Prospective, post approval, ethics committee approved, multicenter, non-randomized clinical trial. 156 patients at 11 clinical sites in the European Union were enrolled. Analysis was performed on 107 patients with 3 months (M) follow-up and 89 patients with 6 M follow-up. Binocular uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) were measured as primary endpoints at 1 week, 3 M and 6 M postoperatively. Moreover, WIOL centration and subjective evaluation of patient’s expectations and satisfaction through patient’s questionnaires were also evaluated.
Results:
Mean binocular UDVA was 0.05 ±0.07 logMAR at 3 M and 0.02 ±0.09 logMAR (20/20) at 6 M. Mean binocular UIVA was 0.06 ±0.10 logMAR (20/20) at 3 and 6 M. Mean binocular UNVA was 0.22 ±0.15 logMAR and 0.22 ±0.11 logMAR (20/32) at 3 M and 6 M, respectively. A great number of patients expressed high satisfaction postoperatively.
Conclusions:
Based on the 6 month follow-up outcome results of this prospective multicenter trial, the bioanalogic WIOL-CF EDOF IOL provided good functional uncorrected vision at all distances.
Financial Disclosure:
NONE
