Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan.
Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan.
Am J Ophthalmol. 2014 Mar;157(3):532-9.e1. doi: 10.1016/j.ajo.2013.11.006. Epub 2013 Nov 13.
To assess the long-term clinical outcomes of Implantable Collamer Lens (Visian ICL; STAAR Surgical) implantation for moderate to high myopia.
Retrospective observational case series.
This study evaluated 41 eyes of 41 patients with myopic refractive errors of -4.00 to -15.25 diopters (D) who underwent ICL implantation and routine postoperative examinations. Before surgery, and 1 and 6 months and 1, 4 and 8 years after surgery, we assessed the safety, efficacy, predictability, stability, and adverse events of the surgery.
The safety and efficacy indices were 1.13 ± 0.27 and 0.83 ± 0.36. At 8 years, 68.3% and 85.4% of the eyes were within 0.5 and 1.0 D, respectively, of the targeted correction. Manifest refraction changes of -0.32 ± 0.73 D occurred between 1 month and 8 years. The mean endothelial cell loss from preoperative levels was 6.2% at 8 years. Two eyes (4.9%) developed clinically significant symptomatic cataract during the follow-up period. Simultaneous lens extraction and phacoemulsification with IOL implantation was successfully performed in these 2 eyes.
According to our experience, ICL implantation was overall good in measures of safety, efficacy, predictability, and stability for the correction of moderate to high myopia during the 8-year observation period, suggesting its long-term viability as a surgical option for the treatment of such eyes.
评估可植入式 Collamer 透镜(Visian ICL;STAAR Surgical)植入治疗中高度近视的长期临床效果。
回顾性观察性病例系列研究。
本研究评估了 41 例近视屈光不正为-4.00 至-15.25 屈光度(D)的患者的 41 只眼,这些患者接受了 ICL 植入和常规术后检查。在手术前以及手术后 1 个月、6 个月、1 年、4 年和 8 年,我们评估了手术的安全性、有效性、可预测性、稳定性和不良事件。
安全性和有效性指数分别为 1.13±0.27 和 0.83±0.36。在 8 年时,68.3%和 85.4%的眼分别在 0.5 和 1.0 D 的目标矫正范围内。1 个月至 8 年间,明视屈光度变化为-0.32±0.73 D。8 年后,平均内皮细胞丢失率从术前水平的 6.2%。在随访期间,有 2 只眼(4.9%)发生了临床上明显的症状性白内障。在这 2 只眼中,同时进行了晶状体提取和超声乳化联合 IOL 植入术。
根据我们的经验,在 8 年的观察期内,ICL 植入术在安全性、有效性、可预测性和稳定性方面总体上对中高度近视的矫正效果良好,表明其作为治疗此类眼睛的手术选择具有长期可行性。