双腔球囊顶压器的研制及在孔源性视网膜脱离复位术中的应用

目的研制一种可用于治疗孔源性视网膜脱离（RRD）的双腔球囊顶压器，并观察其在RRD复位术中的疗效。方法独立设计眼用双腔球囊顶压器并委托厂家生产样品；选择同期RRD患者74例（74眼），A组40眼，采用自制双腔球囊巩膜外顶压术；B组34眼，采用常规节段性巩膜外垫压术；观察2组手术效果。结果A、B2组术后3个月时视网膜解剖复位率、最佳矫正视力的差异均无统计学意义（P〉0．05）。但A组手术时间少于B组，术后3个月时术眼的柱镜度数与术前比较，差异无统计学意义（P〉0．05）；而B组术后3个月术后柱镜度数较术前明显增加（P〈0．05）。结论研制的双腔球囊顶压器（专利号：ZL200720018362．9）经测试安全性及物理性能合格。应用该产品治疗临床上单个或数个裂孔引起的RRD（C1级及以下），效果可靠、创伤小，并发症少，具有较高的推广和使用价值。

Development and clinical application of an double-cavity balloon oppressor in primary retinal detachment surgery

Objective To develop a double-cavity balloon oppressor for treatment of rhegmatogenous retinal detachnlent (RRD) , and to investigate and compare the effects of temporary balloon buckle and segmental scleral buckle for RRD. Methods The double-cavity balloon oppressor was designed and made by Qingdao Sewoon Medical Co, LTD, then it was tested in safety and physical performance. Sixty cases of patients with RRD (74) were selected for our study. Double-cavity balloon oppressor were used for 40 patients in group A. The conventional segmental scleral buckling surgery was used on 34 patients in Group B. None eye was operated with Scleral buckling surgery in our study. Results There were no significant difference at the time of retinal anatomic reduction and the rate of postoperative best corrected visual acuity after 3 months of surgery between Croup A and B . The mean surgical team were about (27 ±8.60) minutes in group A and (47 ± 14. 3) minutes in group B. There was no significant difference between 3 months after surgery and pre-operative in group A ( P > 0.05), while difference was significant between 3 months after surgery and pre-operative in group B ( P < 0.05). Conclusions It is accurate and reliable to apply the double-cavity balloon oppressor (the patent No: ZL 200720018362.9) for RRD surgery and it will provide an economic, efficient and convenient choice.