Clinical Investigation of Expanded Designs of Aspheric Diffractive Multifocal Low-Add 1-Piece IOL: +2.75 D and +3.25 D
Purpose
The purpose of this clinical trial is to evaluate the safety and effectiveness of TECNIS Multifocal Low-Add 1-Piece IOL Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D).
Methods
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). A total of 445 subjects were enrolled and implanted in the clinical study across 19 clinical sites (18 in the US and 1 in the UK). Of these, 147 were in the ZKB00 IOL group, 150 in the ZLB00 IOL group and 148 in the monofocal control group.
Results
Statistically significant improvements (p<0.0001) in the proportion of subjects that reported never wearing glasses were found for both ZKB00 subjects (61.3%) and ZLB00 subjects (75.0%) compared to the ZCB00 control subjects (2.1%) at 6 months. The TECNIS Multifocal Low-Add IOL, Models ZKB00 and ZLB00 demonstrated improved capabilities at near without glasses compared to the monofocal group. Significantly (p<0.0001) more ZKB00 subjects (81.0%) and ZLB00 subjects (85.9%) were able to function comfortably without glasses at near compared to ZCB00 monofocal subjects (33.1%). Directed reports of optical visual symptoms will also be discussed.
Conclusion
TECNIS Multifocal Low-Add IOL Models ZKB00 and ZLB00 provided a significantly higher proportion of spectacle independence compared to a monofocal IOL without significant optical/visual symptoms.