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

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.