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

Abstract

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.