Shimizu Kimiya, Kamiya Kazutaka, Igarashi Akihito, Kobashi Hidenaga
From the Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan.
Medicine (Baltimore). 2016 Apr;95(14):e3270. doi: 10.1097/MD.0000000000003270.
The study shows a promising next-generation surgical option for the correction of moderate to high ametropia. Hole implantable collamer lens (ICL), STAAR Surgical, is a posterior chamber phakic intraocular lens with a central artificial hole. As yet, however, no long-term comparison of the clinical results of the implantation of ICLs with and without such a hole has hitherto been conducted. A prospective, randomized, controlled trial was carried out in order to compare the long-term clinical outcomes of the implantation, in such eyes, of ICLs with and without a central artificial hole.Examinations were conducted of the 64 eyes of 32 consecutive patients with spherical equivalents of -7.53 ± 2.39 diopters (D) (mean ± standard deviation) in whom implantation of a Hole ICL was performed in 1 eye, and that of a conventional ICL was carried out in the other, by randomized assignment. Before 1, 3, and 6 months, and 1, 3, and 5 years after surgery, the safety, efficacy, predictability, stability, intraocular pressure, endothelial cell density, and adverse events of the 2 surgical techniques were assessed and compared over time.The measurements of LogMAR uncorrected and corrected distance visual acuity 5 years postoperatively were -0.17 ± 0.14 and -0.24 ± 0.08 in the Hole ICL group, and -0.16 ± 0.10 and -0.25 ± 0.08 in the conventional ICL group. In these 2 groups, 96% and 100% of eyes, respectively, were within 1.0 D of the targeted correction 5 years postoperatively. Manifest refraction changed by -0.17 ± 0.41 D and -0.10 ± 0.26 D occurred in from 1 month to 5 years in the Hole and conventional ICL groups, respectively. Only 1 eye (3.1%), which was in the conventional ICL group, developed an asymptomatic anterior subcapsular cataract.Both Hole and conventional ICLs corrected of ametropia successfully throughout the 5-year observation period. It appears likely that the presence of the central hole does not significantly affect these visual and refractive outcomes.
UMIN000018771.
该研究显示了一种用于矫正中度至高度屈光不正的有前景的下一代手术选择。STAAR Surgical公司的带孔可植入式角膜接触镜（ICL）是一种具有中央人工孔的后房型有晶状体眼人工晶状体。然而，迄今为止，尚未对有无这种孔的ICL植入临床结果进行长期比较。为了比较有无中央人工孔的ICL在这类眼中植入的长期临床结果，进行了一项前瞻性、随机、对照试验。对连续32例患者的64只眼进行检查，这些患者的等效球镜度数为-7.53±2.39屈光度（D）（平均值±标准差），通过随机分配，一只眼植入带孔ICL，另一只眼植入传统ICL。在术前1、3和6个月以及术后1、3和5年，对这两种手术技术的安全性、有效性、可预测性、稳定性、眼压、内皮细胞密度和不良事件进行评估并随时间进行比较。术后5年，带孔ICL组的LogMAR未矫正和矫正远视力测量值分别为-0.17±0.14和-0.24±0.08，传统ICL组分别为-0.16±0.10和-0.25±0.08。在这两组中，术后5年分别有96%和100%的眼在目标矫正的1.0 D范围内。带孔ICL组和传统ICL组从术后1个月到5年的明显屈光变化分别为-0.17±0.41 D和-0.10±0.26 D。只有1只眼（3.1%），在传统ICL组，出现了无症状的前囊下白内障。在整个5年观察期内，带孔和传统ICL均成功矫正了屈光不正。中央孔的存在似乎并未显著影响这些视觉和屈光结果。
UMIN000018771。
