From the University Eye Hospital, Ruhr University, Bochum, Germany (Dick); Asian Eye Institute, Makati City, Philippines (Ang); Auckland Eye Limited, Auckland, New Zealand (Corbett); Augen- & Laserklinik, Castrop-Rauxel, Germany (Hoffmann); Augentagesklinik am Spreebogen, Berlin, Germany (Tetz); Hospital La Arruzafa, Córdoba, Spain (Villarrubia); Hospital Universitario Quirónsalud Madrid, Madrid, Spain (Palomino, Castillo-Gomez); Johnson & Johnson Vision, Santa Ana, California (Tsai, Thomas, Janakiraman).
J Cataract Refract Surg. 2022 Nov 1;48(11):1270-1276. doi: 10.1097/j.jcrs.0000000000000971. Epub 2022 May 12.
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.
Multicenter clinical setting.
Prospective randomized comparative study.
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.
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.
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.
比较 Tecnis Synergy 多焦点(ZFR00V 型)人工晶状体与 AcrySof PanOptix 三焦点(TFNT00 型)人工晶状体在双侧白内障手术患者中的临床效果。
多中心临床设置。
前瞻性随机对照研究。
年龄在 22 岁及以上的患者被随机分配(2:1)行双侧 ZFR00V 或 TFNT00 人工晶状体植入术。主要终点包括 40cm 处双眼距离矫正近视力(DCNVA)的平均值、33cm 处明视和中间视觉的 DCNVA、明视低对比度矫正远视力(CDVA)和中间视觉 CDVA、非定向患者对眼部/视觉症状问卷的反应以及安全性。
在植入人工晶状体的 150 例患者中,97 例 ZFR00V 人工晶状体患者中有 95 例和 53 例 TFNT00 人工晶状体患者中有 52 例完成了 3 个月的随访。ZFR00V 和 TFNT00 组的大多数患者均达到了 20/25 或更好的双眼 CDVA(100%比 96.2%)和 40cm(88.4%比 75.0%)和 33cm(78.9%比 51.9%)处的双眼 DCNVA。40cm 处双眼 DCNVA 的组间平均差异有利于 ZFR00V 人工晶状体(0.5 行 Snellen;95%置信区间,0.012 至 0.089;P≤0.05)。同样,33cm 处双眼明视和中间视觉的 DCNVA(每行 Snellen 0.8 个;均 P≤0.05 比 TFNT00)和明视高对比度和低对比度 CDVA(每行 Snellen 0.5 个;均 P≤0.05 比 TFNT00)也有利于 ZFR00V 人工晶状体。两种人工晶状体的患者报告的眼部/视觉症状和安全性通常相似。
在接受白内障手术的患者中,ZFR00V 人工晶状体的视力范围广泛,尤其是近距离视力,并且中间视觉表现优于 TFNT00 人工晶状体。