Purpose

To report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.

Design

Multicenter randomized clinical trial.

Participants

A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.

Methods

Patients were enrolled at 16 clinical centers and randomly assigned 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

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, reoperation for glaucoma, or loss of light perception. Secondary outcome measures included IOP, glaucoma medical therapy, and visual acuity.

Results

The cumulative probability of failure after 5 years of follow-up was 42% in the tube group and 35% in the trabeculectomy group (P = 0.21; hazard ratio = 1.31; 95% confidence interval = 0.86–2.01). At 5 years, IOP (mean ± standard deviation) was 13.4 ± 3.5 mmHg in the tube group and 13.0 ± 5.2 mmHg in the trabeculectomy group (P = 0.52), and the number of glaucoma medications (mean ± standard deviation) was 2.2 ± 1.3 in the tube group and 1.3 ± 1.4 in the trabeculectomy group (P < 0.001).

Conclusions

Trabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy. No significant difference in the rate of surgical failure was observed between the 2 surgical procedures at 5 years.

中文翻译：

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五年随访后初次插管与小梁切除术研究的治疗结果

 目的

报告初次管状小梁切除术 (PTVT) 研究的 5 年治疗结果。

 设计

多中心随机临床试验。

 参加者

共有 242 名药物未控制的青光眼且既往没有进行过眼部切开手术的患者的 242 只眼睛，其中管组 125 名患者，小梁切除术组 117 名患者。

 方法

患者在 16 个临床中心入组，并随机分配接受管分流术（350 mm ² Baerveldt 青光眼植入物）治疗或丝裂霉素 C (MMC) 小梁切除术（0.4 mg/ml，持续 2 分钟）治疗。

 主要观察指标

主要结局指标是手术失败率，定义为眼压 (IOP) > 21 mmHg 或较基线降低 < 20%、IOP ≤ 5 mmHg、青光眼再次手术或光感丧失。次要结果指标包括眼压、青光眼药物治疗和视力。

 结果

5 年随访后，插管组的累积失败概率为 42%，小梁切除术组为 35%（ P = 0.21；风险比 = 1.31；95% 置信区间 = 0.86–2.01）。 5 年时，管组 IOP（平均值±标准差）为 13.4 ± 3.5 mmHg，小梁切除术组为 13.0 ± 5.2 mmHg（ P = 0.52），青光眼药物数量（平均值 ± 标准差）为 2.2 ±管组为 1.3，小梁切除术组为 1.3 ± 1.4（ P < 0.001）。

 结论

在 PTVT 研究 5 年随访后，MMC 小梁切除术和管分流手术产生相似的 IOP，但小梁切除术后所需的青光眼药物较少。 5 年时，两次手术之间的手术失败率没有显着差异。