Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant:: Longer term results -: Is bigger better?
Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant:: Longer term results -: Is bigger better?
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DOI：
10.1016/s0161-6420(99)90532-8
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发表时间：
1999-12-01
期刊：
影响因子：
13.7
通讯作者：
Varma, R
中科院分区：
文献类型：
--
作者：
Britt, MT;LaBree, LD;Varma, R
目的：报告一项比较350 mm(2)和500 mm(2) Baerveldt青光眼植入物的随机临床试验的长期结果。设计：随机对照试验的延长随访。参与者：1991年3月至1993年4月，在Doheny眼科研究所，107例因非新生血管性青光眼合并无晶状体、假晶状体或滤光片失效而导致眼压（IOP）不受控制的患者被随机分配到350-mm2或500- mm2 Baerveldt植入体的手术中。方法：采用随机数字表法将患者分为两组。记录术前IOPs和视力。回顾临床记录，以确定术后IOPs、视力、使用的药物数量以及整个随访期间发生的种植体相关并发症。主要结局指标：成功定义为IOP大于或等于6mmhg，小于或等于21 mmHg，连续两次或两次以上随访，且没有进一步青光眼手术或青光眼引起的光感丧失。结果：350-mm(2)组总成功率为87%，500-mm(2)组总成功率为70% （P = 0.05）。350-mm(2)组平均随访37个月（1-76个月），500-mm(2)组平均随访34个月（5-77个月）。随着时间的推移，两组种植体的生命表成功率都有所下降，从350-mm(2)组的98%和500-mm(2)组的92%，到350-mm(2)组的79%和500-mm(2)组5年的累计成功率。350-mm(2)组50%的患者视力改善或保持不变，500-mm(2)组46%的患者视力保持不变。5年随访期间的并发症也有统计学上的相似。结论：长期结果表明，350 mm(2) Baerveldt假体比500 mm(2)假体在控制整体IOP方面更成功。间隔比较表明，在植入的第一、第二、第三、第四和第五年，350-mm(2)种植体的成功率更高。两组患者的视力、种植体相关并发症和平均IOPs在统计学上无显著差异。
Objective: To report the longer term results of a randomized, clinical trial comparing the 350-mm(2) and the 500-mm(2) Baerveldt glaucoma implants.Design: Extended follow-up on a randomized, controlled trial.Participants: Between March 1991 and April 1993, 107 patients with uncontrolled intraocular pressure (IOP) due to non-neovascular glaucoma associated with aphakia, pseudophakia, or failed filters were randomly assigned for surgical placement of either the 350-mm2 or the 500-mm(2) Baerveldt implant at the Doheny Eye Institute.Methods: A random-numbers table was used to assign each patient to one of the two groups. Preoperative IOPs and visual acuities were recorded. Clinical records were reviewed to ascertain postoperative IOPs, visual acuities, number of medications used, and implant-related complications that occurred throughout the follow-up period.Main Outcome Measures: Success was defined as IOP of 6 mmHg or greater and of 21 mmHg or less in two or more consecutive follow-up visits without further glaucoma surgery or loss of light perception attributable to glaucoma.Results: The overall success rates were 87% for the 350-mm(2) group and 70% for the 500-mm(2) group (P = 0.05). Average follow-up was 37 months (range, 1-76 months) for the 350-mm(2) group and 34 months (range, 5-77 months) for the 500-mm(2) group. The life-table success rates declined over time for both implant groups, from a high of 98% for the 350-mm(2) group and 92% for the 500-mm(2) group at 1 year to a cumulative success rate of 79% for the 350-mm(2) group and 66% for the 500-mm(2) group at 5 years. Visual acuities were better or remained the same in 50% of the patients in the 350-mm(2) group and 46% of those in the 500-mm(2) group. Complications during the 5-year follow-up were also statistically similar.Conclusions: The longer term results show that the 350-mm(2) Baerveldt implant is more successful than the 500-mm(2) implant for overall IOP control. Interval comparisons indicate a higher rate of success for the 350-mm(2) implant in the first, second, third, fourth, and fifth years of implantation. Visual acuities, implant-related complications, and average IOPs were statistically indistinguishable between the two groups.