Visual outcomes and safety of an extended depth-of-focus 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

15 sites in the United States.

DESIGN

Prospective, randomized, patient-masked/evaluator-masked clinical trial.

METHODS

Randomized participants received either the ZXR00 or ZCB00 IOL bilaterally. The 6-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 IOL (ZXR00 IOL, n = 148; ZCB00 IOL control, n = 151). At the 6-month follow-up, mean binocular uncorrected distance VA was comparable between ZXR00 and ZCB00 IOL recipients (P = .1011). The ZXR00 IOL group had significantly better mean binocular uncorrected intermediate VA and uncorrected near VA (both P < .0001) than the ZCB00 IOL group. The mean binocular distance-corrected intermediate VA and distance-corrected near VA were also better in the ZXR00 IOL group (both P < .0001). More ZXR00 IOL recipients reported wearing spectacles none of the time or a little of the time for overall vision at 6 months compared with the ZCB00 IOL group (85.0% vs 59.9%, P < .0001). In the ZXR00 IOL-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 dysphotopsia, compared with the TECNIS 1-piece monofocal IOL.