Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan.
Ophthalmology. 2010 Dec;117(12):2287-94. doi: 10.1016/j.ophtha.2010.03.054. Epub 2010 Jul 3.
To assess the 1-year clinical outcomes of toric Visian Implantable Collamer Lens (ICL; STAAR Surgical, Nidau, Switzerland) implantation for moderate to high myopic astigmatism.
Prospective, observational case series.
Fifty-six eyes of 32 consecutive patients, with spherical equivalent errors of -4.00 to -17.25 diopters (D) and cylindrical errors of -0.75 to -4.00 D, who underwent toric ICL implantation.
Before and 1 week and 1, 3, 6, and 12 months after surgery, the safety, efficacy, predictability, stability, and adverse events of the surgery were assessed in eyes undergoing toric ICL implantation. Ocular higher-order aberrations (HOAs) and contrast sensitivity (CS) function also were evaluated before and 1 year after surgery.
Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), safety index, efficacy index, predictability, stability, adverse events, HOAs, and CS function.
The logarithm of the minimum angle of resolution (logMAR) UCVA and logMAR BSCVA were -0.11 (corresponding to Snellen equivalent 20/16) ± 0.12 and -0.19 (corresponding to 20/12.5) ± 0.08 1 year after surgery, respectively. The safety and efficacy indices were 1.17 ± 0.21 and 1.00 ± 0.29. At 1 year, 91% and 100% of the eyes were within 0.5 and 1.0 D, respectively, of the targeted correction. Manifest refraction changes of -0.07 ± 0.27 D occurred from 1 week to 1 year. For a 4-mm pupil, fourth-order aberrations were changed, not significantly, from 0.05 ± 0.02 μm before surgery to 0.06 ± 0.03 μm after surgery (P = 0.38, Wilcoxon signed-rank test). Similarly, for a 6-mm pupil, fourth-order aberrations were not significantly changed, merely from 0.20 ± 0.08 μm before surgery to 0.23 ± 0.11 μm after surgery (P = 0.15). The area under the log CS function was significantly increased from 1.41 ± 0.15 before surgery to 1.50 ± 0.13 after surgery (P < 0.001). No vision-threatening complications occurred during the observation period.
In the authors' experience, the toric ICL performed well in correcting moderate to high myopic astigmatism during a 1-year observation period, suggesting its viability as a surgical option for the treatment of such eyes.
评估 toric Visian 可植入式 Collamer 透镜(ICL;STAAR Surgical,Nidau,瑞士)治疗中高度近视散光的 1 年临床结果。
前瞻性、观察性病例系列研究。
32 例连续患者的 56 只眼,等效球镜度数为-4.00 至-17.25 屈光度(D),圆柱镜度数为-0.75 至-4.00 D,行 toric ICL 植入术。
对接受 toric ICL 植入的患者,术前及术后 1 周、1、3、6 和 12 个月,评估手术的安全性、有效性、可预测性、稳定性和不良事件。还评估了眼的高阶像差(HOAs)和对比敏感度(CS)功能。
未矫正视力(UCVA)、最佳矫正视力(BCVA)、安全性指数、有效性指数、可预测性、稳定性、不良事件、HOAs 和 CS 功能。
术后 1 年,logMAR UCVA 和 logMAR BCVA 分别为-0.11(相当于 Snellen 等效 20/16)±0.12 和-0.19(相当于 20/12.5)±0.08。安全性和有效性指数分别为 1.17±0.21 和 1.00±0.29。术后 1 年,91%和 100%的眼均在 0.5 和 1.0 D 的目标矫正范围内。术后 1 周至 1 年,实际屈光度变化为-0.07±0.27 D。瞳孔直径为 4mm 时,四阶像差术后与术前相比无明显变化,从 0.05±0.02μm 变为 0.06±0.03μm(P=0.38,Wilcoxon 符号秩检验)。同样,瞳孔直径为 6mm 时,四阶像差也无明显变化,从术前的 0.20±0.08μm 变为术后的 0.23±0.11μm(P=0.15)。术后 log CS 函数的曲线下面积显著增加,从术前的 1.41±0.15 增加到术后的 1.50±0.13(P<0.001)。观察期间未发生危及视力的并发症。
在作者的经验中,toric ICL 在 1 年观察期内治疗中高度近视散光效果良好,表明其作为此类眼治疗的手术选择具有可行性。