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First Author: S.Schmickler GERMANY
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The purpose of this clinical study is to perform a market assessment with the TECNIS® Multifocal Low-Add 1-Piece IOLs, Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D).
Augen-Zentrum-Nordwest, Ahaus, Germany
In a prospective, EU-multicenter, open-label study the TECNIS® Multifocal 1-Piece IOL with expanded designs will be implanted bilaterally in cataract patients (n= 30). After having signed informed consent, subjects will be bilaterally implanted with either two ZKB00 or ZLB00 IOLs. Follow-up visits will take place at 1 week after surgery for each eye and at 1 month and 3 months for both eyes. Key evaluation criteria will include mean uncorrected monocular distance visual acuity and distance-corrected monocular near visual acuity at the one-month visit. Further evaluation criteria will be binocular distance-corrected near and far vision, depth-of-focus vision and subject satisfaction (via questionnaire).
The final analysis will comprise 1 and 3 months follow up data of 30 patients from up to 6 investigational sites in the EU. Mean uncorrected monocular distance acuity is expected to be comparable within the groups. Distance corrected monocular near visual acuity is to be expected according to the IOL design features. The depth of focus testing is expected to reveal good far, intermediate and near acuities with good postoperative medical and lens findings, typical for cataract surgery.
The study is in its initial stage, but the bilateral implantation of expanded TECNIS® Multifocal Low-Add 1-Piece IOLs is expected to address the need of patients within the range of available multifocal IOL technologies. Good visual acuity for far, intermediate and near combined with a reduction in spectacle dependency is to be expected.
... research is funded, fully or partially, by a competing company