Visual Outcomes From the Ide Clinical Study of Multifocal Low-Add 1‑Piece IOLs
The purpose of this clinical trial was to evaluate the safety and effectiveness of TECNIS Multifocal Low-Add 1-Piece IOL Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D).
This study was a prospective, multicenter, bilateral, open-label, evaluator-masked, modified-parallel group, 1-year clinical investigation of the TECNIS Multifocal Low-Add IOL Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D). The study began in November 2012, and this presentation summarizes data through 6 months. A total of 445 subjects were enrolled and implanted in the study across 19 sites; 147 were in the ZKB00 group, 150 in the ZLB00 group and 148 in the ZCB00 monofocal control group.
Mean binocular UCDVA was logMAR 0.008 for ZKB00 subjects, logMAR 0.016 for ZLB00 subjects, and logMAR -0.005 for control subjects (20/20 Snellen line equivalent for all groups). Statistically significant differences (p<0.0001) were found between IOL groups for binocular UCNVA at 40 cm. The ZKB00 group outperformed the ZCB00 control group for UCNVA by 2.7 to 3.1 lines of near acuity, and the ZLB00 multifocal lens group outperformed the ZCB00 group by 2.8 to 3.5 lines. Defocus testing results, spectacle independence and optical/visual symptoms will also be presented.
The results of the TECNIS Multifocal Low-Add IOLs, Models ZKB00 and ZLB00, clinical trial demonstrated statistically significant differences in near visual acuity and spectacle independence compared to the control.