Toric人工晶状体植入术有效性和安全性的多中心研究

Abstract

目的 评价普诺明?Toric人工晶状体(IOL)治疗合并角膜规则散光的成年白内障患者的有效性和安全性.方法 多中心、随机、开放、阳性平行对照临床研究.选取2014年5月至2016年5月在9家医院就诊的白内障合并角膜规则散光且符合入选标准的患者共121例(121只眼),男性45例,女性76例;中位年龄71岁(42~88岁).121例患者通过中央随机系统随机分配至试验组和对照组.试验组60例(60只眼)植入爱博诺德(北京)医疗科技有限公司的普诺明?Toric IOL(型号:AT1BH~AT6BH),对照组61例(61只眼)植入美国Alcon公司的AcrySof?IQ Toric IOL(型号:SN6AT2~SN6AT7).术后1 d、1周、1个月、3个月、6个月、1年进行随访,记录视力、IOL轴位、裂隙灯显微镜检查结果、残余散光度数和对比敏感度.采用χ2检验、独立样本t检验、Mann-Whitney U检验、基于秩次的重复测量方差分析、两因素非参数方差分析进行统计学分析.结果 共118例患者完成6个月随访,其中试验组59例,对照组59例,两组最佳矫正远视力(BCDVA)达到20/40的患眼百分比分别为100%(59/59)、98.31%(58/59),率差为1.69%,率差的95%可信区间的下限(-1.60%)>-10.00%(非劣效界值为10.00%),试验组非劣效于对照组.共90例患者完成了1年随访,其中试验组43例,对照组47例.术后1年两组BCDVA达到20/40的患眼百分比分别为试验组97.67%(42/43)、对照组97.87%(46/47),两组之间差异无统计学意义(χ2=0.00,P=0.95);两组裸眼远视力(UCDVA)达到20/40的患眼百分比分别为试验组81.40%(35/43),对照组82.98%(39/47),两组之间差异无统计学意义(χ2=0.04,P=0.84).术后1年试验组和对照组之间在明光、暗光、明光眩光、暗光眩光下18.0 c/d的对比敏感度比较,差异无统计学意义(U=468.50,P=0.17;U=528.00,P=0.28;U=465.50,P=0.19;U=629.00,P=0.39);残余散光比较差异无统计学意义(U=798.50,P=0.08);IOL旋转度数比较差异无统计学意义(U=869.00,P=0.25).术后两组均无患者出现严重的炎性反应及与IOL有关的其他并发症.结论 普诺明?Toric IOL用于治疗合并角膜规则散光的白内障患者,术后视觉质量、散光矫正效果、旋转稳定性、安全性均与AcrySof?IQ Toric IOL相当.

Objective To evaluate the effectiveness and safety of Proming?Toric intraocular lens (IOL) in adults with cataract combined with corneal regular astigmatism. Methods Multicentre, randomized,open and positive parallel controlled clinical study.A total of 121 patients(121 eyes)who had cataract combined with corneal regular astigmatism and met the inclusion criteria were enrolled in 9 hospitals from May 2014 to May 2016. There were 45 males and 76 females and the median age was 71(42-88)years old.A total of 121 patients(121 eyes)were randomly assigned to the study group and the control group through the Central Randomization System. Sixty patients (60 eyes) of the study group were implanted with Proming?Toric IOL(Model:AT1BH-AT6BH)from Eyebright Medical Technology(Beijing) Co.,Ltd.,and 61 patients(61 eyes)of the control group were implanted with AcrySof ?IQ Toric IOL(Model:SN6AT2-SN6AT7) from Alcon Laboratories, Inc. The visual acuity, IOL axial position, slit lamp examination, residual astigmatism and contrast sensitivity were recorded at 1 day, 1 week, 1 month, 3 months,6 months and 1 year postoperatively.Statistical analysis was performed using χ2test,independent sample t test, Mann-Whitney U test, Friedman repeated measured ANOVA on ranks and non-parametric 2-factor variance analysis. Results A total of 118 patients completed 6 months of follow-up, including 59 from the study group and 59 from the control group.The difference between the two groups in terms of the percentage of best corrected distance visual acuity (BCDVA) reaching 20/40 was 1.69%[100%(59/59)vs. 98.31%(58/59)], and the lower limit of the 95% CI (-1.60%) was greater than-10.00%. A total of 90 patients were followed up for 1 year, including 43 patients from study group and 47 patients from control group.At 1 year after operation,the percentages of the BCDVA up to 20/40 were 97.67%(42/43)in the study group and 97.87%(46/47) in the control group, and there was no significant difference between the two groups (χ2=0.00, P=0.95);the percentages of the uncorrected distance visual acuity (UCDVA) up to 20/40 were 81.40%(35/43)in the study group and 82.98%(39/47)in the control group,and there was no significant difference between the two groups (χ2=0.04, P=0.84). At 1 year follow-up, the difference of contrast sensitivity at 18.0 c/d under the bright light,dark light,bright glare and dark glare between the two groups was not statistically significant (U=468.50, P=0.17;U=528.00, P=0.28;U=465.50, P=0.19;U=629.00, P=0.39);the difference of residual astigmatism between the two groups was not statistically significant (U=798.50,P=0.08);the difference of IOL rotation degree between the two groups was not statistically significant (U=869.00,P=0.25).There were no severe inflammatory responses nor other complications associated with IOL in both groups at each follow-up point.Conclusion The visual quality,astigmatism correction effect, rotation stability and safety of Proming?Toric IOL for the treatment of cataract combined with corneal regular astigmatism is equivalent to AcrySof? IQ Toric IOL.