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E. K. Altpeter, K. Petermeier, P. Szurman; First Clinical Evaluation of the New Tecnis 1-Piece Multifocal vs. Tecnis Monofocal Intraocular Lens: A Prospective Multicenter Clinical Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5724.
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To compare the new Tecnis multifocal diffractive ZMB00 1-piece hydrophobic acrylic lens (near addition +4 diopters) with the Tecnis monofocal model ZCB00 1-piece hydrophobic acrylic lens.
In a prospective, double-masked multicenter study either the Tecnis 1-piece multifocal IOL (AMO) (n=35) or the monofocal Tecnis 1-piece IOL (AMO) (n=35) were bilaterally implanted in patients with cataract. The study has been approved by the local ethics committee and all patients have signed informed consent. Masked follow-up examinations were performed one day, one week, one to two months and four to six months after surgery and comprised refraction, monocular and binocular visual acuity (near and distance with ETDRS), Radner reading speed, defocus curve, pupil size, keratometry and slit-lamp biomicroscopy. All medical and lens related complications were recorded.
The first 8 eyes finished the 4 weeks follow-up: After one week all multifocal patients achieved UCDVA of 20/25 or better having an average spherical equivalent within ± 0.2 Dpt (± 0.2). After 4 weeks UCDVA improved to 20/20 or better and also the UCNVA was in all eyes 20/25 or better having an average spherical equivalent within ± 0.3 Dpt. All multifocal patients showed a high satisfaction and comfort due to spectacle-free near and distance vision. Three patients reported mild halos with no disturbance. Complications and optical visual symptoms were low and comparable to the monofocal IOL group
The first results indicate that the new multifocal IOL based on the proven concept of a 1-piece hydrophobic acrylic IOL design combines the advantages of ease of implantation and low complication rate with the benefit of reduced spectacle dependency.
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