METHODS: This is a population-based, cross-sectional, descriptive, analytical, retrospective, multicentre study in which each co-author collected data from at least the last 10 patients (up to a maximum of 30) with Visian ICL phakic lens implantation. One eye from each subject was randomly selected for study inclusion, and the variables analysed were: age, gender, visual acuities with and without correction pre and post-surgery, preoperative and residualrefraction, keratometry, endothelial cellular density, anterior chamber depth from endothelium, central corneal pachymetry, intraocular pressure, white-white, implanted lens (power and size), expected and achieved spherical equivalent (SEQ) post-surgery at one month after surgery.
RESULTS: A sample of 140 eyes was obtained from 140 patients with a mean age of 31.35 ± 7.28 years. Mean preoperative SEQ was -6.33 ± 3.69D, mean CDVA was 0.96 ± 0.16, ACD was 3.30 ± 0.29 mm, WTW 12.02 ± 0.40 mm, CCT 535.03 ± 37.68 µm, ECD 2684.37 ± 313.74 cels/mm2 and IOP 14.84 ± 2.59 mmHg. 66.4% of the implanted lenses were spherical ICLs and 33.6% toric, with a mean power of -7.81 ± 4.09D and a mean cylinder of 2.27 ± 1.23D. 5.7% of the implanted lenses were hypermetropic. The mean SEQ target selected was +0.04 ± 0.27D. 48.92% of the implanted lenses were of size 13.2 mm, with the remaining 36.69, 10.79 and 3.60% being of sizes 12.6, 12.1 and 13.7 mm, respectively. At one month after surgery a residual SEQ of -0.01 ± 0.31D was obtained. The efficacy and safety indices were 1.06 ± 0.18 and 1.10 ± 0.19, respectively. The mean central vault was 508.80 ± 201.04 µm. The accuracy between the calculated SEQ and the obtained SEQ was 99.3% for spherical lenses and 88.2% for Cyl correction. The mean ECD at 1 month after surgery was 2805.53±273.30céls/mm2, which was a difference from preoperative of 0.11% (p = 0.922), similarly, the mean IOP was 13.98 ± 2.57 mmHg, which was a difference of -0.92 ± 2.80 mmHg.
CONCLUSIONS: ICL phakic lens surgery is an effective, safe and predictable procedure. There were no significant changes in endothelial cell count or intraocular pressure measurement one month after surgery.
方法:这是基于人口的,横截面,描述性,描述性分析,回顾性,多中心研究,其中每位合著者收集了至少最后10例(最多30例)的VisianICL晶状体植入术患者的数据。从每个受试者中随机选择一只眼睛进行研究纳入。分析的变量是:年龄,性别,手术前后有或没有矫正的视力,术前和残余屈光,角膜曲率测量,内皮细胞密度,内皮前房深度,中央角膜测厚,眼内压,白色-白色,植入晶状体(功率和尺寸),手术后一个月预期和达到的球形当量(SEQ)。
结果:从140名患者中获得140只眼的样本,平均年龄为31.35±7.28岁。术前平均SEQ为-6.33±3.69D,平均CDVA为0.96±0.16,ACD为3.30±0.29mm,WTW12.02±0.40mm,CCT535.03±37.68µm,ECD2684.37±313.74细胞/mm2和IOP14.84±2.59mmHg。植入晶状体的66.4%为球面ICL,33.6%为复曲面,平均功率为-7.81±4.09D,平均柱面为2.27±1.23D。5.7%的植入晶状体为远视晶状体。选择的平均SEQ靶标为+0.04±0.27D。48.92%的植入式晶状体尺寸为13.2mm,其余36.69、10.79和3.60%的尺寸为12.6、12.1和13.7毫米,分别。在手术后一个月,获得-0.01±0.31D的残余SEQ。疗效和安全性指数分别为1.06±0.18和1.10±0.19。平均中央拱顶为508.80±201.04µm。计算的SEQ和获得的SEQ之间的准确度对于球面透镜为99.3%,对于Cyl校正为88.2%。术后1个月的平均ECD为2805.53±273.30céls/mm2,与术前相差0.11%(p=0.922),同样,平均IOP为13.98±2.57mmHg,差异为-0.92±2.80mmHg。
结论:ICL晶状体手术是一种有效的,安全和可预测的程序。术后1个月内皮细胞计数或眼压测量无明显变化。