WIOL-CF International Registry Outcomes Ewa Mrukwa-Kominek Medical University of Silesia, Katowice Amsterdam, October 2013, ESCRS Annual Meeting
WIOL Registry WIOL Registry is an organized system that: uses observational study methods to collect uniform data to evaluate specified outcomes for patients with bilaterally implanted WIOL-CF collects objective data from international trial implantations provides a real-world view of clinical practice, patient outcomes and safety related to WIOL-CF implantations assist in development of WIOL-CF implantation and outcomes excellence by providing objective feedback data enables various analyses for the purpose of publications or presentations (international, national, center level) Outcomes more representative of what is really achieved in clinical practice compared to strict clinical trial designs
Methodology & Design International, non-interventional, non-randomized, observational registry of patients with bilaterally implanted bioanalogic WIOL-CF Data collected: History, biometry, VA, Glare/Halo, Spectacle independence, Subjective satisfaction at 2 weeks and 3/6/12 months ecrf used (www.wiolregistry.com)
Interim Analysis Status as of September 17, 2013: 37 patients with data registered in 7 participating centers in 6 countries... THANK YOU! 30 patients with 2 weeks data available (60 eyes) 15 patients with 3-month data available (30 eyes) 100% of investigators have implanted WIOL-CF for the first time Lead Surgeon Center E. Mrukwa-Kominek University Hospital, Katowice, Poland I. Nijs Ziekenhuis Oost Limburg, Genk, Belgium M.R. Garcia Clinica Vistalaser, Málaga, Spain C.L. Moser Hospital Creu Roja, Barcelona, Spain R.E.T. Ang Asian Eye Institute, Manila, Philippines C. Lenis Novius Clinic, Stockholm, Sweden K. Sakatani Minotamirai Eye Clinic, Yokohama, Japan Demography: Age (years) Mean Median Min Max SD 59.9 59.5 40 79 7.83
Uncorrected VA Binocular, 3 months Excellent visual acuity for distance and intermediate vision, almost 1.0 (decimal) and J1 reached on average respectively, very good near vision 100% 90% 80% Uncorrected binocular VA N Mean SD UDVA (decimal) 14 1.1 0.16 UIVA (Jaeger) 12 J1.3 1.49 UNVA (Jaeger) 15 J2.6 1.58 86% 100% 100% 50% 67% 83% 100% 80% 60% 60% 87% 70% 1.0 and better 0.9 and better 0% J1 and better J3 and better 40% J3 and better J5 and better UDVA binocular 1.0 and better > 86% 0.9 and better 100% UIVA binocular J1 and better > 67% J3 and better > 83% J4 and better 100% UNVA binocular J3 and better > 60% J5 and better > 87% J6 and better 100%
Uncorrected VA Monocular, 3 months Uncorrected monocular VA N Mean SD UDVA (decimal) 22 1.0 0.22 UIVA (Jaeger) 22 J2 2.43 UNVA (Jaeger) 24 J2.9-100% 50% 73% 91% 80% 70% 60% 63% 73% 90% 80% 70% 75% 87% 0% 1.0 and better 0.8 and better UDVA monocular 1.0 and better > 73% 0.8 and better > 91% 50% J1 and better J3 and better UIVA monocular J1 and better > 63% J3 and better > 73% 60% J3 and better J5 and better UNVA monocular J3 and better > 75% J5 and better > 87%
Best Corrected VA Binocular/Monocular, Safety BCNVA close to J1 confirms safety of WIOL-CF implantation and possibility to correct the polyfocal optics with spectacles if necessary Binocular N Mean BCDVA (decimal) 13 1.09 BCNVA (Jaeger) 13 J1.6 Monocular N Mean BCDVA (decimal) 28 1.05 BCNVA (Jaeger) 28 J1.7
Best Corrected VA Binocular/Monocular, Safety BCNVA close to J1 confirms safety of WIOL-CF implantation and possibility to correct the polyfocal optics with spectacles if necessary Binocular N Mean BCDVA (decimal) 13 1.09 BCNVA (Jaeger) 13 J1.6 Monocular N Mean BCDVA (decimal) 28 1.05 BCNVA (Jaeger) 28 J1.7 Results in line or better compared to the Czech study Outcomes confirmed in international, cross-border set-up
Spectacle Independence 93% of patients spectacle independent on near distance 7% Wearing spectacles? N = 14 93% Yes 7% No 93%
Only mild, undisturbing Glare/Halo observed 100% of WIOL-CF patients without disturbing optical phenomena* # 13% 87% None (87%) Mild-Undisturbing (13%) Severe-Disturbing (0%) N = 15 * Solicited reporting # Usual level of freedom from disturbing optical phenomena: Multifocal IOLs: 75-80% Monofocal IOLs: 91-97%
Subjective Satisfaction 100% of WIOL-CF patients express subjective satisfaction 36% 14% 50% Very satisfied (14%) Satisfied (50%) Rather satisfied (36%) Rather not satisfied (0%) Not satisfied (0%)
Conclusions Despite small sample size and short follow-up, WIOLRegistry outcomes support the results of the Czech multicenter study in international, cross-border set-up Excellent result for far and intermediate vision Very good near vision High best-corrected VA values confirm safety of polyfocal optics Very high patient satisfaction and spectacle independence rates Glare/Halo at very low level