Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens.

PURPOSE: To compare the clinical performance of the TECNIS Synergy multifocal (model ZFR00V) intraocular lens (IOL) with that of the AcrySof PanOptix Trifocal (model TFNT00) IOL in patients undergoing bilateral cataract surgery. SETTING: Multicenter clinical setting. DESIGN: Prospective randomized comparative study. METHODS: Patients aged 22 years or older were randomly assigned (2:1) to bilateral implantation with ZFR00V or TFNT00 IOLs. End points included the mean binocular distance-corrected near visual acuity (DCNVA) at 40 cm, photopic and mesopic DCNVAs at 33 cm, photopic low-contrast corrected distance visual acuity (CDVA) and mesopic CDVA, nondirected patient responses to an ocular/visual symptoms questionnaire, and safety. RESULTS: Of the 150 patients implanted with IOLs, 95 of the 97 patients with ZFR00V IOLs and 52 of the 53 patients with TFNT00 IOLs completed the 3-month follow-up. Most patients in the ZFR00V and TFNT00 groups achieved 20/25 or better binocular CDVA (100% vs 96.2%) and DCNVA measured at 40 cm (88.4% vs 75.0%) and 33 cm (78.9% vs 51.9%). The mean between-group difference in binocular DCNVA at 40 cm favored ZFR00V IOLs (0.5 lines Snellen; 95% CI, 0.012 to 0.089; P ≤ .05). Similarly, the mean binocular photopic and mesopic DCNVAs at 33 cm (0.8 lines Snellen each; both P ≤ .05 vs TFNT00) and photopic high-contrast and low-contrast CDVA (0.5 lines Snellen each; both P ≤ .05 vs TFNT00) favored ZFR00V IOLs. Patient-reported ocular/visual symptoms and safety were generally similar between the 2 IOLs. CONCLUSIONS: The ZFR00V IOL showed an extensive range of vision, particularly through near distances, and better mesopic performance than the TFNT00 IOL in patients undergoing cataract surgery.

Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD.

This clinical investigation compared the clinical performance of two marketed ophthalmic viscoelastic devices (OVDs): the bacterially derived Healon PRO OVD (test) and the animal-derived Healon OVD (control) under normal use conditions during cataract removal and lens implantation. This prospective, multicenter, randomized, parallel, participant/evaluator masked, postmarket investigation enrolled 139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group). Both test and control OVDs were used, at a minimum, to inflate the anterior chamber and protect the endothelium prior to cataract extraction according to the standard procedure. The surgeon completed a postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP) was measured before surgery and at the 1 day postoperative visit with Goldmann applanation tonometry. Any IOP measurement of 30 mmHg or higher was considered a "spike" and recorded as a study-specific, serious adverse event. The bacterially derived Healon PRO OVD was found to be statistically noninferior to the overall clinical performance of the animal-derived Healon OVD control; thus, the primary hypothesis was satisfied. There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses. The Healon PRO OVD showed statistically significant improvements in surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement. The safety profile was also similar between OVD groups with regards to serious and/or device-related adverse events, as well as medical and lens findings. The results of this clinical investigation support the safety and effectiveness of the bacterially derived, currently marketed Healon PRO OVD and indicate that the intraocular surgical performance was similar between the two OVDs.