Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial.

PURPOSE: To compare the clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, vs TECNIS IOL, model ZCB00, in cataract patients. SETTING: Multicenter clinical setting. DESIGN: Prospective, randomized, subject/evaluator-masked clinical trial. METHODS: Cataract patients aged ≥22 years were randomly assigned 1:1 to bilateral implantation with ZFR00V or ZCB00. Key end points at 6 months postsurgery included monocular and binocular visual acuities at 4 m, 66 cm, 33 cm, and/or 40 cm, binocular distance-corrected defocus testing, patient-reported outcomes, and safety. RESULTS: 272 patients were implanted with ZFR00V (135) or ZCB00 (137). At 6 months, 83/131 (63.4%) ZFR00V patients demonstrated 20/25 or better combined monocular distance-corrected vision at far, intermediate, or near, compared with 5/130 (3.8%) ZCB00 patients. ZFR00V demonstrated excellent binocular uncorrected vision at intermediate (0.022 logMAR) and distance-corrected vision at 40 cm (0.047 logMAR). Strong ZFR00V performance persisted under mesopic conditions (0.244 logMAR or ∼20/32 Snellen), where improvement over ZCB00 with distance-corrected vision at near was 3.5 lines. ZFR00V provided a broad range of functional vision (20/32 or better) through -3.5 diopters of defocus (29 cm). Most ZFR00V patients reported no spectacle wear overall (93.1%) or at all 4 viewing distances combined (87.8%), and 55.7% qualified as completely spectacle independent. Relatively low proportions of ZFR00V patients reported being very/extremely bothered by halos (13.7%), starbursts (11.5%), or night glare (8.4%). The safety profile was similar between IOL groups. CONCLUSIONS: TECNIS Synergy ZFR00V demonstrated improved intermediate and near vision, increased range of vision, and greater spectacle independence vs TECNIS monofocal ZCB00.

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens.

PURPOSE: To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon). DESIGN: Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial. PARTICIPANTS: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision. METHODS: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria. MAIN OUTCOME MEASURES: The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances. RESULTS: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6. CONCLUSIONS: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.