国产囊袋张力环用于白内障手术维持囊袋张力的有效性和安全性的多中心临床研究

目的 评价CTR型国产囊袋张力环用于白内障手术维持囊袋张力的临床有效性和安全性。 设计 多中心、随机、开放、阳性产品、平行对照设计。 研究对象 年龄＞18岁，核硬度为1~3级且术中需要维持囊袋张力的白内障患者119例。 方法 受试者随机分配入试验组（59例）和对照组（60例），行白内障超声乳化术及囊袋张力环、人工晶状体植入术，试验组植入CTR型国产囊袋张力环（爱博诺德（北京）医疗科技股份有限公司，中国），对照组植入TENSIOBAG型囊袋张力环（卡尔蔡司医疗技术有限公司，德国）。于术后1~2天，1周，1、3、6个月和1年及以上进行随访评估。采用t检验、Wilcoxon秩和检验、卡方检验、CMH卡方检验、精确概率检验、确切概率法等方法进行统计学分析，比较两组的有效性和安全性。 主要指标 矫正及裸眼远视力、屈光度、人工晶状体偏心及囊膜收缩情况、角膜内皮细胞密度。结果 术后各随访期，两组术眼最佳矫正远视力、裸眼远视力组间均无统计学差异（P均＞0.05），相对于基线期的变化值均无统计学差异（P均＞0.05）；术后6个月及1年时，两组术眼屈光度均无统计学差异（P均＞0.05），相对于基线期的变化值均无统计学差异（P均＞0.05）。试验组术后1~2天，1周，1、3个月、1年及以上随访时均未发现人工晶状体偏心，6个月随访时发现1例稍偏位但1年及以上随访时已居中；对照组术后各随访期未发现人工晶状体偏心，两组无统计学差异（P均＞0.05）。两组受试者各随访期均未发现囊膜收缩。在安全性方面，两组受试者在术后各随访时间点，裂隙灯检查结果均无统计学差异（P均＞0.05），均未发现瞳孔阻滞现象，眼压无统计学差异（P均＞0.05）；术后1年及以上随访时，两组角膜内皮细胞密度无统计学差异（P均＞0.05）。 结论 国产CTR型囊袋张力环（爱博诺德（北京）医疗科技股份有限公司，中国）用于白内障手术维持囊袋张力的有效性和安全性与TENSIOBAG型囊袋张力环（卡尔蔡司医疗技术有限公司，德国）相当。

Multi-center clinical trial of efficacy and safety of domestic capsular tension ring for cataract surgery to maintain capsular tension

Objective To evaluate the clinical efficacy and safety of the domestic CTR model capsular tension ring for cataract surgery to maintain capsular tension. Design Multicenter, randomized, open, positive and parallel controlled clinical studies. Participants 119 cataract patients aged over 18 years and with grade 1-3 cataract nuclear hardness, which need to maintain capsular tension. Methods Participants were randomly assigned to the study group (59 cases) or the control group (60 cases). The phacoemulsification and the implantation of a capsular tension ring and intraocular lenses (IOL) were performed. The subjects in study group were implanted with the domestic CTR model capsular tension ring (Eyebright Medical Technology (Beijing) Co., Ltd., China), while the subjects in control group were implanted with a TENSIOBAG model capsular tension ring (Carl Zeiss Medical Technology Co., Ltd., Germany). Follow-up evaluation at 1~2 days, 1 week, 1 month, 3 months, 6 months, and 1 year or above after surgery. Statistical analysis was performed using t-test, Wilcoxon rank sum test, chi-square test, CMH chi-square test, exact probability test, and exact probability method to compare the efficacy and safety between the two groups. Main Outcome Measures The best corrected distant visual acuity(BCDVA), uncorrected distant visual acuity(UCDVA), diopter, postoperative IOL decentration, capsule contraction and the counts of corneal endothelial cells. Results At all the follow-up times after the operation, there was no statistically significant difference between the two groups (all P>0.05) in the BCDVA, the UCDVA and their changes from the baseline. At 6 months and 1 year after the operation, there was no statistically significant difference between the two groups (all P>0.05) in the diopter and the changes from the baseline. There was no statistically significant difference between the two groups (all P>0.05) in IOL decentration. In the study group, no IOL decentration was found at 1-2 days, 1 week, 1 month, 3 months and 1 year or above after the operation; one case with slightly decentration was found at 6-month visit but the IOL centered at 1-year-or-above visit. No IOL decentration was found in the control group at all the follow-ups. There was no capsule contraction in the two groups during the follow-up period. In terms of safety, there was no statistically significant difference between the two groups (all P>0.05) in the results of slit lamp examination and intraocular pressure at the follow-ups and no pupillary blockage was found. There was no significant difference between the two groups (all P>0.05) in corneal endothelial cell density at 1 year or above after the operation. Conclusion The efficacy and safety of  domestic CTR model capsular tension ring (Eyebright Medical Technology (Beijing) Co., Ltd., China) for capsular tension maintenance in cataract surgery is comparable to TENSIOBAG model capsular tension ring (Carl Zeiss Medical Technology Co., Ltd., Germany).