中央孔型后房型人工晶状体临床应用有效性及安全性研究

Effectiveness and safety of implantable collamer lens with a central hole for the correction of moderate to high myopia

目的观察中央孔型后房型人工晶状体(ICL V4c)植入矫正中高度近视的有效性,评估ICL V4植入术后安全性。方法收集2018年5~12月期间在南京中医药大学附属江苏省中医院接受ICL V4c植入术的中高度近视患者33例(66只眼),随访患者裸眼视力(UCVA)、最佳矫正视力(BCVA)、角膜曲率、屈光度、眼压、拱高、内皮细胞计数至术后1年,随访时间为术后1、6、12个月。结果术前UCVA、等效球镜(SE)与术后1、6、12个月相比均有显著统计学差异(P<0.01)。术后1、6、12个月之间拱高比较,术后1个月与术后6个月相比拱高差异具有显著统计学意义(P<0.01),术后6个月与术后12个月相比,拱高无统计学差异。角膜曲率(K1、K2)在术前与术后1、6、12个月之间数据均无统计学差异。术后1个月眼压较术前眼压降低,有显著统计学差异(P<0.01),术后6个月较术前眼压有统计学差异(P<0.05),术后12个月眼压与术前眼压无统计学差异。术前BCVA为0.9±0.14;UCVA术后1个月为1.04±0.12,6个月为1.05±0.12,12个月为1.10±0.14。术后的3个时段的UCVA与术前BCVA相比均有显著性统计学意义(P<0.01)。结论ICV V4植入术能有效提高中高度近视患者裸眼视力,人工晶状体植入术后稳定性好,手术安全性高,是中高度近视安全有效的矫正方式。

Objective To investigate the efficacy of posterior chamber implantable collamer lens with a central hole(ICL V4c)for the correction of high myopia,and to evaluate the safety of ICL V4c implantation.Methods A retrospective case series study.66 eyes of 33 patients with moderate or high myopia who received ICL V4c implantation in Jiangsu Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine from May 2018 to December 2018 were selected.The patients'uncorrected distance visual acuity(UCVA),best-corrected visual acuity(BCVA),corneal curvature,refraction,intraocular pressure,vault,and endothelial cell count were recorded preoperatively and postoperatively,and followed up for 1 year after surgery.Results There were significant differences in UCVA and spherical equivalent(SE),before operation compared with 1 month,6 months and 12 months after operation(P<0.01).The vault at 1 month,6 months,and 1 year after surgery were compared.The difference of vault at 1 month and 6 months after surgery was statistically significant(P<0.01).There was no significant difference in vault between 6 months and 1 year postoperatively.There was no statistical difference in corneal curvature(K1,K2)between preoperative and postoperative 1 month,6 months,and 1 year.The intraocular pressure at 1 month after surgery was significantly lower than that before the surgery(P<0.01).The intraocular pressure at 6 months after surgery was statistically different from that before surgery(P<0.05).There was no significant difference in the intraocular pressure between 1 year after surgery and before surgery.The mean preoperative BCVA was 0.9±0.14 and the mean postoperative UCVA at 1 month,6 months,and 1 year were 1.05±0.12,1.04±0.12,and 1.10±0.14,respectively.Compared with it,the difference of UCVA in the three postoperative periods was statistically significant(P<0.01).Conclusions The central hole posterior chamber intraocular lens implantation can effectively improve the naked vision of patients with middle and high myopia.The intraocular lens implantation has good stability and high safety for correcting middle or high myopia.