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-mm² 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.

中文翻译：

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一年的随访后主管与小梁切除术研究的治疗结果

目的

在主管与小梁切除术（PTVT）研究中报告1年治疗结果。

设计

多中心随机临床试验。

参加者

242例未经药物控制的青光眼且未进行过切开眼科手术的患者的242眼，包括试管组125例和小梁切除术组117例。

方法

在16个临床中心招募患者，并随机分配使用分流管（350毫米^2的Baerveldt青光眼植入物）或使用丝裂霉素C的小梁切除术（MMC； 0.4 mg / ml，持续2分钟）进行治疗。

主要观察指标

眼内压（IOP），青光眼药物治疗，视力，视野，外科手术并发症和衰竭（IOP大于21 mmHg或与基线相比降低了不到20％，IOP小于或等于5 mmHg，青光眼再次手术或失去光感视力）。

结果

随访第一年的累积失败率在试管组为17.3％，在小梁切除术组为7.9％（P  = 0.01；危险比为2.59； 95％置信区间为1.25-5.60）。1年时，小管组的平均±标准差IOP为13.8±4.1 mmHg，小梁切除术组的平均IOP为12.4±4.4 mmHg（P  = 0.01），青光眼用药的数量为2.1±1.4，管组为0.9±1.4在小梁切除术组中（P <0.001）。管组36例（29％）和小梁切除组48例（41％）发生术后并发症（P = 0.06）。试管组的1例患者（1％）和小梁切除术组的8例患者（7％）发生了严重的并发症，需要再次手术或损失2根Snellen线或更多（P  = 0.03）。

结论

在PTVT研究中，MMC小梁切除术1年后比分流管植入术的手术成功率更高。在随访的第一年内，与小管分流术相比，MMC小梁切除术后使用较少的青光眼药物可以降低眼压。与MMC小梁切除术相比，分流管手术后产生视力丧失或需要再次手术的严重并发症的发生率较低。