From the Empire Eye and Laser Center, Bakersfield, California (Chang); Texas Eye and Laser Center, Hurst, Texas (Hu); Lehmann Eye Center, Nacogdoches, Texas (Lehmann); Vance Thompson Vision Clinic, Sioux Falls, South Dakota (Thompson); Johnson & Johnson Vision, Santa Ana, California (Tsai, Thomas).
J Cataract Refract Surg. 2023 Aug 1;49(8):840-847. doi: 10.1097/j.jcrs.0000000000001205.
To compare the clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, vs TECNIS IOL, model ZCB00, in cataract patients.
Multicenter clinical setting.
Prospective, randomized, subject/evaluator-masked clinical trial.
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.
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.
TECNIS Synergy ZFR00V demonstrated improved intermediate and near vision, increased range of vision, and greater spectacle independence vs TECNIS monofocal ZCB00.
比较 Tecnis Synergy 人工晶状体（IOL），型号 ZFR00V 与 Tecnis IOL，型号 ZCB00，在白内障患者中的临床效果。
多中心临床设置。
前瞻性、随机、受测者/评估者盲法临床试验。
年龄≥22 岁的白内障患者按 1:1 随机分配至双眼接受 ZFR00V 或 ZCB00 植入。术后 6 个月的主要终点包括单眼和双眼 4 m、66 cm、33 cm 和/或 40 cm 处的视力、双眼离焦测试、患者报告的结果和安全性。
272 名患者接受了 ZFR00V（135 名）或 ZCB00（137 名）植入。术后 6 个月，83/131（63.4%）名 ZFR00V 患者的远、中、近距联合单眼矫正视力达到 20/25 或以上，而 ZCB00 患者中仅 5/130（3.8%）达到该标准。ZFR00V 在中间距离（0.022 logMAR）和 40 cm 处的距离矫正视力（0.047 logMAR）表现出极好的双眼未矫正视力。在中间距离的暗视条件下（0.244 logMAR 或 ∼20/32 Snellen），ZFR00V 仍保持强劲的性能，与近距距离矫正视力相比，改善了 3.5 行。ZFR00V 通过-3.5 屈光度的散焦（29 cm）提供了广泛的功能性视力（20/32 或以上）。大多数 ZFR00V 患者总体上（93.1%）或在所有 4 个观察距离（87.8%）均无需戴眼镜，55.7%的患者完全无需戴眼镜。相对较少的 ZFR00V 患者报告有光晕（13.7%）、星爆（11.5%）或夜间眩光（8.4%）非常/极度困扰。两组 IOL 的安全性特征相似。
与 Tecnis 单焦点 ZCB00 相比，Tecnis Synergy ZFR00V 显示出更好的中距和近距视力、更大的视力范围和更高的脱镜率。
