From Department of Ophthalmology, Dell Medical School, Austin, TX (E.C.B).
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA (A.C, S.J.G, W.J.F, E.S).
Am J Ophthalmol. 2022 Aug;240:217-224. doi: 10.1016/j.ajo.2022.02.027. Epub 2022 Mar 12.
To identify the risk factors associated with failure of tube shunt surgery.
Pooled analysis of 3 prospective multicenter, randomized clinical trials.
A total of 621 patients with medically uncontrolled glaucoma were enrolled, including 276 from the Ahmed Baerveldt Comparison Study, 238 from the Ahmed Versus Baerveldt Study, and 107 from the tube group of the Tube Versus Trabeculectomy Study. Patients were randomized to treatment with an Ahmed glaucoma valve (model FP7) or Baerveldt glaucoma implant (model 101-350). The associations between baseline risk factors and tube shunt failure were assessed using a Cox proportional hazards regression model. The primary outcome measure was the rate of surgical failure defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, loss of light perception vision, reoperation for glaucoma, or removal of implant.
The cumulative probability of failure after tube shunt surgery was 38.3% after 5 years. In multivariable analyses, baseline factors that predicted tube shunt failure included preoperative IOP (≤ 21 mmHg compared to IOP > 21 and ≤ 25 mmHg; HR, 2.34; 95% CI, 1.52-3.61; P < .001), neovascular glaucoma (HR, 1.79; 95% CI, 1.28-2.52; P = .001), randomized treatment (for Ahmed glaucoma valve; HR, 1.36; 95% CI, 1.04-1.78; P = .025), and age (for 10 year decrease in age; HR, 1.19; 95% CI, 1.09-1.31; P < .001).
Lower preoperative IOP, neovascular glaucoma, Ahmed implantation, and younger age were predictors of tube shunt failure. This Study provides the largest prospectively collected dataset on tube shunt surgery.
确定与引流管手术失败相关的风险因素。
3 项前瞻性多中心随机临床试验的汇总分析。
共纳入 621 例药物治疗无法控制的青光眼患者，包括 Ahmed Baerveldt 比较研究的 276 例、Ahmed 与 Baerveldt 研究的 238 例和 Tube Versus Trabeculectomy 研究的引流管组的 107 例。患者被随机分配至 Ahmed 青光眼阀（型号 FP7）或 Baerveldt 青光眼植入物（型号 101-350）治疗。使用 Cox 比例风险回归模型评估基线风险因素与引流管失败之间的关系。主要观察指标为手术失败率，定义为眼压（IOP）>21mmHg 或较基线值降低<20%、IOP≤5mmHg、光感丧失、青光眼再次手术或植入物取出。
5 年后引流管手术后的累积失败概率为 38.3%。多变量分析显示，预测引流管失败的基线因素包括术前 IOP（≤21mmHg 与 IOP>21mmHg 和≤25mmHg 相比；HR，2.34；95%CI，1.52-3.61；P<.001）、新生血管性青光眼（HR，1.79；95%CI，1.28-2.52；P=0.001）、随机治疗（使用 Ahmed 青光眼阀；HR，1.36；95%CI，1.04-1.78；P=0.025）和年龄（每减少 10 岁；HR，1.19；95%CI，1.09-1.31；P<.001）。
术前 IOP 较低、新生血管性青光眼、Ahmed 植入物和较年轻的年龄是引流管失败的预测因素。本研究提供了最大的前瞻性收集的引流管手术数据集。
