PURPOSE To compare clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, versus TECNIS IOL, model ZCB00, in cataract patients. SETTING Multicenter clinical setting. DESIGN Prospective, randomized, subject/evaluator-masked clinical… Click to show full abstract
PURPOSE To compare clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, versus 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 endpoints at 6 months post-surgery 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 D of defocus (29 cm). The majority of ZFR00V patients reported no spectacle wear overall (93.1%) or at all four 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 versus TECNIS monofocal ZCB00.
               
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