Wiley William F, Epitropoulos Alice T, Whitman Jeffrey, Liang Eva, Sadri Ehsan, Lau George
From the Cleveland Eye Clinic, Elyria, Ohio (Wiley); The Eye Center of Columbus, Columbus, Ohio (Epitropoulos); Key-Whitman Eye Center, Dallas, Texas; Center For Sight, Las Vegas, Nevada (Liang); Visionary Eye Institute, Newport Beach, California (Sadri); Bausch & Lomb, Inc., Bridgewater, New Jersey (Lau).
J Cataract Refract Surg. 2024 Dec 1;50(12):1236-1241. doi: 10.1097/j.jcrs.0000000000001540.
To evaluate the rotational stability and visual performance of the enVista toric intraocular lens (IOL) (MX60ET) in cataract patients with preexisting astigmatism.
6 U.S. sites.
Prospective, multicenter.
Cataract patients 18 years and older with preexisting astigmatism (0.77 to 4.53 diopters [D]) underwent phacoemulsification and implantation of enVista toric IOL (MX60ET). Outcome measures were the proportion of patients with absolute IOL axis rotation of ≤5 degrees, uncorrected and corrected distance visual acuities (UDVA and CDVA) at 4 m, uncorrected intermediate visual acuity (UIVA) at 66 cm, manifest refraction, and adverse events. The patients were followed up on days 1 to 2, 7 to 14, 30 to 60, and 120 to 180.
Mean astigmatism of 101 eyes (101 patients) reduced from 1.47 ± 0.64 D preoperatively to 0.38 ± 0.38 D at days 120 to 180 ( P < .001), with 88.1% (N = 89/101) of eyes achieving astigmatism within 0.75 D. Mean postoperative UDVA and UIVA were 0.10 ± 0.16 and 0.25 ± 0.15 logMAR, respectively. While 79.2% (N = 80/101) of patients had postoperative UDVA of 20/32 or better, 63.9% (N = 62/97) had UIVA of 20/40 or better. The mean toric IOL rotation from the operative visit to days 30 to 60 was 1.97 ± 2.06 degrees, with 97.4% (N = 74/76) of eyes showing toric IOL rotation of 5 degrees or less.
The enhanced enVista toric IOL (MX60ET) demonstrated excellent rotational stability and astigmatic outcomes indicating good efficacy of the IOL for the correction of astigmatism during cataract surgery.
评估enVista散光型人工晶状体(IOL)(MX60ET)在已有散光的白内障患者中的旋转稳定性和视觉性能。
美国6个地点。
前瞻性、多中心研究。
年龄在18岁及以上、已有散光(0.77至4.53屈光度[D])的白内障患者接受了超声乳化白内障吸除术并植入enVista散光型IOL(MX60ET)。观察指标包括绝对IOL轴旋转≤5度的患者比例、4米处的未矫正和矫正远视力(UDVA和CDVA)、66厘米处的未矫正中视力(UIVA)、显验光以及不良事件。在术后第1至2天、第7至14天、第30至60天和第120至180天对患者进行随访。
101只眼(101例患者)的平均散光度数从术前的1.47±0.64 D降至第120至180天时的0.38±0.38 D(P <.001),88.1%(N = 89/101)的眼睛散光度数在0.75 D以内。术后平均UDVA和UIVA分别为0.10±0.16和0.25±0.15 logMAR。79.2%(N = 80/101)的患者术后UDVA达到20/32或更好,63.9%(N = 62/97)的患者UIVA达到20/40或更好。从手术当天到第30至60天,散光型IOL的平均旋转度数为1.97±2.06度,97.4%(N = 74/76)的眼睛散光型IOL旋转度数在5度或以下。
增强型enVista散光型IOL(MX60ET)显示出出色的旋转稳定性和散光矫正效果,表明该IOL在白内障手术中矫正散光的疗效良好。