Song X D, Hao Y S, Li X R, Zhang H, Ye J, Wang N L
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Science Key Lab., Beijing 100730, China.
Zhonghua Yan Ke Za Zhi. 2016 Feb;52(2):99-103. doi: 10.3760/cma.j.issn.0412-4081.2016.02.005.
To evaluate the safety and efficacy of the domestic foldable one-piece aspheric intraocular lens (IOL, Model: A1-UV) for the treatment of cataract.
A prospective randomized controlled clinical research were conducted. One hundred and nineteen cases (119 eyes) of cataract patients were randomly assigned to the study group (58 cases) and the control group (61 cases). The study group were implanted with the domestic made aspheric intraocular lens (Model: A1-UV) and the control group were implanted with imported aspheric intraocular lens (Model: SN60WF, Alcon Laboratories, Inc.). The visual acuity and the slit lamp examination were evaluated 1-2 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively. In addition, the contrast sensitivity tests were carried out 3 months, 6 months and 1 year postoperatively. Data were analyzed by chi-square test and independent t-test.
100 patients had completed 1 year of follow-up, among which 49 cases were from the study group and 51 cases were from the control group. No severe inflammation or complications associated with intraocular lens were noted in either group within 1 year follow-up. The mean BCDVA, BCNVA, UCDVA, UCNVA(Log MAR) of the study group and the control group were 0.04±0.11, 0.11±0.17, 0.13±0.20, 0.35± 0.19 and 0.07±0.15, 0.15±0.20, 0.18±0.23, 0.41±0.21 at 1 year postoperatively. No statistically significant differences were noted between groups in mean BCDVA, BCNVA, UCDVA, UCNVA (t=-1.39, P=0.166; t=- 1.25, P=0.216; t=-1.06, P=0.292; t=-1.59, P=0.116) at 1 year postoperatively. And there was no significant difference in visual acuity between the two groups (P>0.05) 1-2 day, 1 week, 1 month, 3 months and 6 months postoperatively. The difference of the contrast sensitivity between the two groups was not statistically significant (P>0.05), besides the contrast sensitivity of the study group was significantly better than the control group at 12c/d, 18 c/d under bright light(t=2.18, P=0.031; t=2.67, P=0.009) at 3 months postoperatively. And the mean contrast sensitivity of the study group and the control group at 12c/d, 18 c/d under bright light were 1.31 ± 0.36, 0.86 ± 0.41 and 1.15 ± 0.40, 0.65 ± 0.44 at 3 months postoperatively.
The safety and efficacy of the domestic made foldable one-piece aspheric intraocular lens (Model: A1-UV) for the treatment of cataract is equivalent to the imported aspheric intraocular lens (Model: SN60WF).
评估国产折叠一体式非球面人工晶状体（IOL，型号：A1-UV）治疗白内障的安全性和有效性。
进行一项前瞻性随机对照临床研究。119例（119眼）白内障患者被随机分为研究组（58例）和对照组（61例）。研究组植入国产非球面人工晶状体（型号：A1-UV），对照组植入进口非球面人工晶状体（型号：SN60WF，爱尔康实验室公司）。术后1-2天、1周、1个月、3个月、6个月和1年评估视力和裂隙灯检查情况。此外，术后3个月、6个月和1年进行对比敏感度测试。数据采用卡方检验和独立t检验进行分析。
100例患者完成了1年随访，其中研究组49例，对照组51例。1年随访期间两组均未发现与人工晶状体相关的严重炎症或并发症。术后1年，研究组和对照组的平均最佳矫正远视力（BCDVA）、最佳矫正近视力（BCNVA）、未矫正远视力（UCDVA）、未矫正近视力（UCNVA，对数最小分辨角）分别为0.04±0.11、0.11±0.17、0.13±0.20、0.35±0.19和0.07±0.15、0.15±0.20、0.18±0.23、0.41±0.21。术后1年两组间BCDVA、BCNVA、UCDVA、UCNVA的差异无统计学意义（t=-1.39，P=0.166；t=-1.25，P=0.216；t=-1.06，P=0.292；t=-1.59，P=0.116）。术后1-2天、1周、1个月、3个月和6个月两组视力差异无统计学意义（P>0.05）。两组对比敏感度差异无统计学意义（P>0.05），但术后3个月在明亮光线下研究组12c/d、18c/d的对比敏感度显著优于对照组（t=2.18，P=0.031；t=2.67，P=0.009）。术后3个月在明亮光线下研究组和对照组12c/d、18c/d的平均对比敏感度分别为1.31±0.36、0.86±0.41和1.15±0.40、0.65±0.44。
国产折叠一体式非球面人工晶状体（型号：A1-UV）治疗白内障的安全性和有效性与进口非球面人工晶状体（型号：SN60WF）相当。
