Pepose Jay S, Hayashida Jon, Hovanesian John, Davies James, Labor Phillips Kirk, Whitman Jeffrey, Carter Harvey, Colvard Michael, Buckhurst Phillip J, Khodai Omid, Mittleman David, Feinerman Gregg
From Pepose Vision Institute (Pepose) and the Department of Ophthalmology and Visual Sciences (Pepose), Washington University School of Medicine, St. Louis, Missouri, Bausch & Lomb (Hayashida, Khodai), Aliso Viejo, Harvard Eye Associates, (Hovanesian), Laguna Hills, Davies Eye Center (Davies), Carlsbad, Colvard-Kandavel Eye Center (Colvard), Encino, and Feinerman Vision Center (Feinerman), Newport Beach, California, Eye Consultants of Texas (Labor), Grapevine, Key-Whitman Eye Center (Whitman), and Carter Eye Center (Carter), Dallas, Texas, and Mittleman Eye Center (Mittleman), West Palm Beach, Florida, USA; Plymouth University (Buckhurst), Plymouth, United Kingdom.
From Pepose Vision Institute (Pepose) and the Department of Ophthalmology and Visual Sciences (Pepose), Washington University School of Medicine, St. Louis, Missouri, Bausch & Lomb (Hayashida, Khodai), Aliso Viejo, Harvard Eye Associates, (Hovanesian), Laguna Hills, Davies Eye Center (Davies), Carlsbad, Colvard-Kandavel Eye Center (Colvard), Encino, and Feinerman Vision Center (Feinerman), Newport Beach, California, Eye Consultants of Texas (Labor), Grapevine, Key-Whitman Eye Center (Whitman), and Carter Eye Center (Carter), Dallas, Texas, and Mittleman Eye Center (Mittleman), West Palm Beach, Florida, USA; Plymouth University (Buckhurst), Plymouth, United Kingdom.
J Cataract Refract Surg. 2015 Feb;41(2):295-305. doi: 10.1016/j.jcrs.2014.05.043.
To evaluate the safety and effectiveness of the Trulign toric intraocular lens (IOL) in adults with cataract.
Eight private practices in the United States and 1 in Canada.
Prospective randomized single-masked multicenter study.
A toric IOL (1.25 D, 2.00 D, or 2.75 D, determined by a toric calculator) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter (D) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range (predicted postoperative astigmatism 0.83 to 1.32 D) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL (Crystalens) control group.
The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder (P < .001) and uncorrected distance visual acuity (P = .002) than the control group at the 120- to 180-day visit. The mean monocular uncorrected vision at distance, intermediate, and near was 20/25, 20/22, and 20/39, respectively, with the 1.25 D, 2.00 D, and 2.75 D toric IOLs in aggregate (toric group). In addition, 96.1% of patients (123/128) had 5.0 degrees or less absolute IOL rotation postoperatively. Regarding safety, the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met.
The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision.
Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study. Drs. Buckhurst, Whitman, Feinerman, Hovanesian, Davies, Labor, and Carter are consultants to Bausch & Lomb. At the time of the study, Drs. Hayashida, and Khodai were employees of Bausch & Lomb. Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned.
评估Trulign散光型人工晶状体（IOL）在成年白内障患者中的安全性和有效性。
美国的8家私人诊所和加拿大的1家诊所。
前瞻性随机单盲多中心研究。
将一枚散光型IOL（1.25 D、2.00 D或2.75 D，由散光计算器确定）植入符合条件的年龄相关性白内障患者，这些患者需要16.00至27.00屈光度（D）的球面IOL度数，且预计术后散光为0.83至2.50 D。最低柱镜范围（预计术后术后散光为0.83至1.32 D）内的眼睛按1:1比例随机分为1.25 D散光型IOL组和非散光型可调节IOL（Crystalens）对照组。
在120至180天随访时，1.25 D散光型IOL组的绝对柱镜度数降低百分比（P <.001）和未矫正远视力（P = 0.002）在统计学上显著高于对照组。散光型IOL组（1.25 D、2.00 D和2.75 D散光型IOL总体）的平均单眼远、中、近未矫正视力分别为20/25、20/22和20/39。此外，96.1%的患者（123/128）术后人工晶状体绝对旋转度数为5.0度或更小。在安全性方面，达到了矫正视力保留终点以及并发症和不良事件的发生率终点。
散光型IOL在减少术前角膜散光影响方面安全有效，并且提供了出色的未矫正远视力和中视力以及功能性近视力。
佩波斯博士是博士伦公司的顾问，并且是本研究的医学监测人。巴克赫斯特博士、惠特曼博士、费纳曼博士、霍瓦内西安博士、戴维斯博士、拉博尔博士和卡特博士是博士伦公司的顾问。在研究期间，林田博士和霍代博士是博士伦公司的员工。科尔瓦德博士和米特尔曼博士在提及的任何材料或方法上拥有财务或所有权权益。
