Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. Issue 3 (March 2022)

• Record Type: Journal Article
• Authors: Chang, Daniel H.; Janakiraman, Devi Priya; Smith, Pamela J.; Buteyn, Anne; Domingo, Joy; Jones, Jason J.; Christie, William C.
• Is Part Of: Journal of cataract and refractive surgery. Volume 48:Issue 3(2022)
• Page Start: 288
• Page End: 297
• Publication Date: 2022-03
• Subjects: 617.7
• DOI: 10.1097/j.jcrs.0000000000000747
• Languages: English
• ISSNs: 0886-3350

Abstract

Abstract : Randomized comparison of the TECNIS Symfony (ZXR00) and the TECNIS 1-piece monofocal (ZCB00) intraocular lenses in cataract surgery demonstrates improved intermediate and near vision with TECNIS Symfony. 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: 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.