Kohnen Thomas, Lapid-Gortzak Ruth, Ramamurthy Dandapani, Bissen-Miyajima Hiroko, Maxwell Andrew, Kim Tae-Im, Modi Satish
Department of Ophthalmology, Goethe-University, Frankfurt, Germany.
Department of Ophthalmology, Amsterdam University Medical Centers, Amsterdam, Netherlands.
Clin Ophthalmol. 2023 Jan 10;17:155-163. doi: 10.2147/OPTH.S377234. eCollection 2023.
To investigate visual and safety outcomes of AcrySof IQ PanOptix (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies.
This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies' design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4-5 m), intermediate (UCIVA, DCIVA; 60-66 cm), and near (UCNVA, DCNVA; 40 cm) were measured.
The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3-6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1 logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4-5 m) to near (-3.00 D; optically equivalent to 33 cm) was observed 3-6 months after TFNT00 implantation. At 3-6 months, 88.2% of first eyes achieved an MRSE ≤0.50 D and 88.7% of second eyes achieved an MRSE ≤0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent.
This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs.
基于六项前瞻性多中心研究的汇总分析，调查AcrySof IQ PanOptix（型号TFNT00）这款三焦点、矫正老花眼的人工晶状体（IOL）在多个国家不同种族患者中的视觉和安全性结果。
这项汇总分析纳入了来自全球56个中心进行的六项前瞻性临床研究的成年患者。在通过超声乳化白内障吸除术后，所有患者均植入TFNT00；根据研究设计，随访时间从3个月到12个月不等。测量双眼散焦曲线；绝对显验光球镜等效度（MRSE）；以及在远距（4 - 5米）、中间距（60 - 66厘米）和近距（40厘米）的双眼明视未矫正和矫正视力（UCDVA、BCDVA；UCIVA、DCIVA；UCNVA、DCNVA）。
该研究纳入了557例患者，其中547例双侧植入了TFNT00人工晶状体（共1094只眼）。分别有多达546例和542例双侧植入患者可获得植入后1个月以及3 - 6个月的双眼视觉数据。在TFNT00植入后3 - 6个月观察到从远距（0.00屈光度[D]，4 - 5米）到近距（-3.00 D；光学等效于33厘米）的连续范围为0.1最小分辨角对数（logMAR）或更好的视力。在3 - 6个月时，88.2%的第一只眼MRSE≤0.50 D，88.7%的第二只眼MRSE≤0.50 D。总体而言，双侧植入TFNT00的患者中，分别有99.3%、92.3%和94.6%的患者双眼明视BCDVA、DCIVA和DCNVA达到0.14 logMAR或更好。眼部不良器械效应和二次手术干预（SSIs）很少见。
这项全球汇总分析表明，TFNT00提供了从远距到33厘米连续范围为0.1 logMAR（约20/25 Snellen）或更好的视力，眼部不良器械效应和SSIs的发生率较低。
