Department of Ophthalmology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan.
Br J Ophthalmol. 2012 Mar;96(3):409-12. doi: 10.1136/bjophthalmol-2011-300148. Epub 2011 Jul 6.
To assess the early clinical outcomes of an ICL with a central hole (Hole ICL) implantation for the correction of moderate to high myopia.
This study evaluated 20 eyes of 20 patients with spherical equivalents of -7.36 ± 2.13 D (mean ± SD) who underwent Hole ICL implantation. Before surgery and at 1 week and 1, 3 and 6 months after surgery, we assessed the safety, efficacy, predictability, stability and adverse events of the surgery.
Logarithm of the minimum angle of resolution (logMAR) uncorrected visual acuity and logMAR best spectacle-corrected visual acuity were -0.20 ± 0.12 and -0.25 ± 0.06, respectively, 6 months after surgery. The safety and efficacy indices were 1.13 ± 0.24 and 1.03 ± 0.30, respectively. At 6 months, 95%, and 100% eyes were within ± 0.5 and ± 1.0 D of the targeted correction, respectively. Change in manifest refraction from week 1 to month 6 was 0.06 ± 0.28 D. No significant rise in intraocular pressure (including pupillary block) or a secondary cataract occurred in any case during the period of observation.
Implantation of a newly developed Hole ICL offered good results for all measures of safety, efficacy, predictability and stability for the correction of moderate to high myopic errors, even without peripheral iridectomy, suggesting its viability as a surgical option for the treatment of such eyes.
评估中央孔(Hole ICL)植入物矫正中高度近视的早期临床结果。
本研究评估了 20 名患者的 20 只眼,这些患者的等效球镜度数为-7.36 ± 2.13 D(平均值 ± 标准差),并接受了 Hole ICL 植入术。在手术前以及手术后 1 周、1 个月、3 个月和 6 个月,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。
术后 6 个月,未经矫正的最小分辨角对数视力(logMAR)和最佳矫正眼镜下的 logMAR 视力分别为-0.20 ± 0.12 和-0.25 ± 0.06。安全性和有效性指数分别为 1.13 ± 0.24 和 1.03 ± 0.30。术后 6 个月,95%和 100%的眼均在± 0.5 和± 1.0 D 的目标矫正范围内。从第 1 周到第 6 个月,屈光度的变化为 0.06 ± 0.28 D。在观察期间,没有眼压升高(包括瞳孔阻滞)或继发性白内障的显著增加。
新开发的 Hole ICL 植入物为中高度近视误差的安全性、有效性、可预测性和稳定性提供了良好的结果,即使没有周边虹膜切除术,也表明其作为治疗此类眼睛的手术选择的可行性。