Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
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DOI：
10.1016/j.ophtha.2018.02.003
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发表时间：
2018-05-01
期刊：
影响因子：
13.7
通讯作者：
Brandt, James
中科院分区：
文献类型：
--
作者：
Gedde, Steven J.;Feuer, William J.;Brandt, James
设计：多中心随机临床试验。参与者：无眼部手术的青光眼患者242只眼，插管组125只眼，小梁切除术组117只眼。方法：在16个临床中心登记患者，随机分配到导管分流术(350 mm(2)Baerveldt青光眼植入物)或小梁切除术联合丝裂霉素C(MMC；主要观察指标：眼压、青光眼药物治疗、视力、视野、手术并发症、失败(眼压>21 mm Hg或较基线下降20%，眼压<5 mm Hg，青光眼再次手术或光感视力丧失)。结果：1年随访失败概率分别为17.3%和7.9%(P=0.01；风险比，2.59；95%可信区间，1.20-5.60)。术后1年平均+/-标准差眼压分别为13.8±-4.1 mm Hg和12.4±-4.4 mm Hg(P=0.001)，青光眼用药例数分别为2.1±-1.4和0.9±-1.4(P<；术后并发症：管组36例(29%)，小梁切除术组48例(41%)(P=0.06)。发生严重并发症需要再次手术或丢失2条Snellen线以上者，插管组1例(1%)，小梁切除术组8例(7%)(P=0.03)。结论：PTVT术后1年小梁切除联合MMC的手术成功率高于插管分流术。在第一年的随访中，与导管分流术相比，小梁切除MMC术后使用较少的青光眼药物可降低眼压。与小梁切除术联合丝裂霉素C相比，管状分流术后发生严重并发症导致视力丧失或需要再次手术的发生率较低。(C)2018年美国眼科学会
Purpose: To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.Design: Multicenter, randomized clinical trial.Participants: Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group.Methods: Patients were enrolled at 16 clinical centers and assigned randomly to treatment with a tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes).Main Outcome Measures: Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision).Results: The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20-5.60). Mean +/- standard deviation IOP was 13.8 +/- 4.1 mmHg in the tube group and 12.4 +/- 4.4 mmHg in the trabeculectomy group at 1 year (P = 0.01), and the number of glaucoma medications was 2.1 +/- 1.4 in the tube group and 0.9 +/- 1.4 in the trabeculectomy group (P < 0.001). Postoperative complications developed in 36 patients (29%) in the tube group and 48 patients (41%) in the trabeculectomy group (P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group (P = 0.03).Conclusions: Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC. (C) 2018 by the American Academy of Ophthalmology