Department of Phaco and Refractive Services, Nethradhama Super Speciality Eye Hospital, Bengaluru, Karnataka, India.
Indian J Ophthalmol. 2023 Mar;71(3):771-778. doi: 10.4103/ijo.IJO_1073_22.
To report the 1-year clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results with Optiflex Genesis and Eyecryl Plus (ASHFY 600) monofocal aspheric intraocular lenses (IOLs) and compare the same with Tecnis-1 monofocal IOL.
This prospective, single-center, single-surgeon, randomized, three-arm study included 159 eyes of 140 eligible patients who underwent cataract extraction with IOL implantation with any of the three study lenses. Clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results were compared at a mean follow-up of 1 year (12 ± 1.20 months).
Preoperatively, age and baseline ocular parameters of all the three groups were matched. At 12 months post-op, no significant differences were noted among the groups in terms of mean postoperative uncorrected and corrected distance visual acuity (UDVA and CDVA, respectively) sphere, cylinder, and spherical equivalent (SE; P > 0.05 for all parameters). Eighty-nine percent eyes in the Optiflex Genesis group as against 96% eyes in the Tecnis-1 and Eyecryl Plus (ASHFY 600) groups were within ± 0.5 D, and 100% of eyes in all the three groups were within ± 1.00 D of SE accuracy. Postoperative internal higher-order aberrations (HOAs) and coma, and mesopic contrast sensitivity at all spatial frequencies were comparable across all the three groups. Two eyes in the Tecnis-1 group, two eyes in the Optiflex group, and one eye in the Eyecryl Plus (ASHFY 600) group underwent YAG capsulotomy at the last follow-up. No eye in any of the groups showed glistenings or required IOL exchange due to any reason.
At 1-year post-op, all the three aspheric lenses showed comparable results in visual and refractive parameters, post-op aberrations, contrast sensitivity, and posterior capsule opacification (PCO) behavior. Further follow-up is needed to evaluate the long-term behavior for refractive stability and PCO rates of these lenses.
CTRI/2019/08/020754 (www.ctri.nic.in).
报告与安全性、有效性、可预测性、对比敏感度、患者满意度、并发症和整体结果相关的 Optiflex Genesis 和 Eyecryl Plus（ASHFY 600）单焦非球面人工晶状体（IOL）的 1 年临床结果，并将其与 Tecnis-1 单焦 IOL 进行比较。
这是一项前瞻性、单中心、单医生、随机、三臂研究，纳入了 140 名符合条件的患者的 159 只眼，这些患者接受了白内障超声乳化吸除术并植入了三种研究晶状体中的任何一种。在平均 1 年（12 ± 1.20 个月）的随访后，比较了与安全性、有效性、可预测性、对比敏感度、患者满意度、并发症和整体结果相关的临床结果。
术前，三组的年龄和基线眼部参数均匹配。术后 12 个月，三组在平均术后未矫正和矫正远距视力（UDVA 和 CDVA，分别）、球镜、柱镜和等效球镜（SE；所有参数的 P 值均>0.05）方面均无显著差异。Optiflex Genesis 组 89%的眼在±0.5 D 范围内，Tecnis-1 组和 Eyecryl Plus（ASHFY 600）组 96%的眼在±1.00 D 范围内，三组 100%的眼在 SE 精度±1.00 D 范围内。三组的术后高阶像差（HOAs）和彗差以及所有空间频率的中亮度对比敏感度均相当。Tecnis-1 组 2 只眼、Optiflex 组 2 只眼和 Eyecryl Plus（ASHFY 600）组 1 只眼在最后一次随访时接受了 YAG 后囊切开术。由于任何原因，任何一组都没有出现闪光或需要更换 IOL。
术后 1 年，所有三种非球面晶状体在视觉和屈光参数、术后像差、对比敏感度和后囊混浊（PCO）方面的结果均相当。需要进一步随访以评估这些晶状体的长期屈光稳定性和 PCO 率。
CTRI/2019/08/020754（www.ctri.nic.in）。
