Abstract：
OBJECTIVE: To analyse the state of refractive surgery with Visian ICL phakic lens implantation in Spain, indicating the mean ranges of implanted powers, visual and refractive outcomes obtained and safety and efficacy indices.
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.
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.
摘要：
目的：分析西班牙VisianICL有晶状体晶状体植入术的屈光手术状况，显示植入功率的平均范围，获得的视觉和屈光结果以及安全性和疗效指数。
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。
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。
