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Elke K. Altpeter, Katrin Petermeier, Peter Szurman; Clinical Evaluation Of The New Tecnis 1-piece Multifocal Vs Tecnis Monofocal Intraocular Lens: 4-6 Month Follow-up. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6189.
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The new TECNIS® multifocal 1-piece IOL (ZMB00) received FDA approval in March 2010. In this study visual outcome was compared with the visual outcome of the TECNIS® monofocal model ZCB00 1- piece-hydrophobic acrylic lens.
In a prospective non-randomized partially blinded multicenter study either the TECNIS® multifocal 1-piece IOL ZMB00 (near addition +4 diopters) (n=35) or the TECNIS monofocal 1-piece IOL ZCB00 (n=35) were bilaterally implanted in patients with cataract. The study was approved by the local ethics committee and all patients signed informed consent. Follow-up examinations were performed regularly until four to six months after surgery and comprised refraction, monocular and binocular visual acuity (near and distance with ETDRS), defocus curve, Radner reading speed, pupil size, keratometry and slit-lamp biomicroscopy. All medical and lens related complications were recorded.
10 multifocal and 5 monofocal patients of our center finished the 4-6 month follow-up: The multifocals showed a UCDVA of 20/16 (-0.06 (± 0.06) LogMar), the BCDVA was 20/16 (-0.1 (± 0.05) LogMar) with an average residual refractive error of -0.17 D (± 0.2). The monofocals were equal. The uncorrected near visual acuity (UCNVA) in the multifocal group was 20/16 (0.04 (± 0.01) LogMar) the distance corrected near visual acuity under mesopic conditions were 20/20 (0.02 (± 0.09) LogMar) and under photopic conditions 20/16 (0.03 (± 0.1) LogMar). Reading performance was better in the multifocal group, all had at least 0.1 LogRad and 120words/minute. In the monofocal group reading performance was 0.7 LogRad for fluent reading. The near visual acuity was reduced: UCNVA 20/50, DCNVA (mesopic) 20/80, DCNVA (photopic) 20/63. The defocus curve of the multifocal lens showed a clear bifocal profile. 2 patients reported severe halos, the other 8 reported none or no-disturbing halos, all multifocal patients were spectacle-free.
The new TECNIS® ZMB00 aspheric 1-piece multifocal IOL provides enhanced near visual acuity also under mesopic conditions and thus a high spectacle independency.
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