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Visual outcomes and safety of the TECNIS Symfony intraocular lens: results of a pivotal clinical trial.

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PURPOSE To compare the effectiveness and safety of the TECNIS Symfony® intraocular lens (IOL; ZXR00) with the TECNIS® 1-piece monofocal IOL (ZCB00). SETTING Fifteen sites in the United States. DESIGN… Click to show full abstract

PURPOSE To compare the effectiveness and safety of the TECNIS Symfony® intraocular lens (IOL; ZXR00) with the TECNIS® 1-piece monofocal IOL (ZCB00). SETTING Fifteen sites in the United States. DESIGN Prospective, randomized, subject/evaluator-masked clinical trial. METHODS Randomized participants received either the ZXR00 or ZCB00 IOL bilaterally. Six-month postoperative outcomes included monocular and binocular distance, intermediate, and near visual acuity (VA), spherical equivalent refraction and refractive cylinder, spectacle wear, and visual symptoms. RESULTS Overall, 299 patients were implanted with a study lens (ZXR00, n = 148; ZCB00 control, n = 151). At 6-month follow-up, mean binocular uncorrected distance VA was comparable between ZXR00 and ZCB00 recipients (P = .1011). The ZXR00 group had significantly better mean binocular uncorrected intermediate VA and uncorrected near VA (both P < .0001) than the ZCB00 group. Mean binocular distance-corrected intermediate VA and distance-corrected near VA were also better in the ZXR00 group (both P < .0001). More ZXR00 recipients reported wearing spectacles "none of the time" or "a little of the time" for overall vision at 6 months compared with the ZCB00 group (85.0% vs 59.9%, P < .0001). In ZXR00-implanted patients, low incidence rates of night glare (mild to moderate, 2.7%), halo (mild to moderate, 13.6%; severe, 2.7%), and starbursts (mild to moderate, 7.5%; severe, 1.4%) were reported. CONCLUSIONS The TECNIS Symfony® IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased spectacle wear and low incidence rates of dysphotopsias, compared with the TECNIS® 1-piece monofocal IOL.

Keywords: zxr00; distance; zcb00; tecnis; tecnis symfony

Journal Title: Journal of cataract and refractive surgery
Year Published: 2021

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