国产预装式人工晶状体系统安全性和有效性的多中心研究

Multi-center study on safety and efficacy of Chinese preloaded intraocular lens system

目的通过对白内障患者术后视觉质量和并发症的临床随访,评价国产AQBHL型预装式人工晶状体(intraocular lens,IOL)系统治疗白内障的有效性和安全性。方法多中心、随机、开放、阳性产品、平行对照临床试验。120例(120眼)受试者随机分为试验组(61例)和对照组(59例),试验组采用国产全预装系统(型号AQBHL)植入IOL(型号AQBH),对照组采用传统植入器和导入头植入IOL(型号A1-UV)。术后1 d、1周、1个月、3个月、6个月和1 a进行随访,每次随访均对患眼进行视力、等效球镜度数、眼压、裂隙灯检查;术后3个月、6个月进行对比敏感度检查;术后1 a进行眼底检查和角膜内皮检查。结果术后各随访时间点,两组受试者裸眼远视力、裸眼近视力、最佳矫正远视力、最佳矫正近视力、等效球镜度数、对比敏感度、眼压的差异均无统计学意义(均为P>0.05);两组受试者的视力、屈光度数均在术后1个月达到稳定状态;术后各随访时间点两组受试者的视力相对术前均有显著提高(均为P<0.01);两组手术推注过程均顺畅,均未发生术中并发症;术后早期的炎性反应,组间比较差异无统计学意义(P>0.05);术后1 a,两组受试者角膜内皮细胞计数和角膜内皮多形性变化比较差异均无统计学意义(均为P>0.05);随访期间未发现IOL变色、混浊、钙化等异常情况,无一例受试者进行二次手术。结论国产AQBHL型预装式IOL系统可提供安全、可靠、可控的IOL植入过程,临床应用的安全性与非预装式推注系统相当;AQBH型IOL与A1-UV型IOL均可有效矫正白内障患者术后视力,矫正效果稳定,视觉质量优秀,生物相容性良好,术后并发症少,临床应用的有效性和安全性较高,可作为治疗白内障患者的有效手段。

Objective To evaluate the efficacy and safety of Chinese AQBHL preloaded intraocular lens(IOL)system through the clinical follow-up of visual quality and complications of cataract patients after operation.Methods Multi-center,randomized,open-label,positive and parallel controlled clinical study was conducted.Totally 120 subjects(120 eyes)were randomly divided into study group(61 cases)and control group(59 cases).IOL(model AQBH)was implanted by a Chinese fully pre-loaded system(model AQBHL)for cases in study group,and IOL(model A1-UV)was implanted using a conventional injector and imported head for cases in control group.Follow-up was performed 1 day,1 week,1 month,3 months,6 months and 1 year after operation.Visual acuity,spherical equivalent,intraocular pressure and slit lamp examinations were performed at each follow-up,contrast sensitivity test was performed 3 months and 6 months after operation,fundus examinations and corneal endothelium examinations were performed 1 year after operation.Results There were no significant differences between the two groups in uncorrected distance vision,uncorrected near vision,best corrected distance vision,best corrected near vision,spherical equivalent,contrast sensitivity and intraocular pressure at each postoperative follow-up(all P>0.05).The visual acuity and diopter of both two groups reached a steady state 1 month after operation.The visual acuity at each follow-up was significantly higher than that before operation for patients in both two groups(all P<0.01).The injection procedure was smooth in both two groups,and no intraoperative complications occurred.The early postoperative inflammatory reactions showed no statistical difference between the two groups(P>0.05).At 1 year after operation,there was no significant difference in the corneal endothelial cell count and corneal endothelium polymorphism between the two groups(both P>0.05).No abnormalities such as discoloration,opacity and calcification of the intraocular lens were observed during the follow-up period.None of the subjects underwent secondary surgery.Conclusion Chinese AQBH preloaded IOL system can provide a safe,reliable and controllable IOL implantation process,and the safety of clinical application is equivalent to that of non-preloaded injector.Both AQBH IOL and A1-UV IOL can effectively correct the postoperative vision of cataract patients,with stable correction effect,excellent visual quality,good biocompatibility,few postoperative complications,high effectiveness and safety in clinical application,and can be used as an effective method for treating cataract patients.