Purpose

To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study.

Design

Multicenter randomized clinical trial.

Participants

Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery.

Methods

Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm² Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes).

Main Outcome Measures

The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) 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. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications.

Conclusions

Practice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.

中文翻译：

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原发管与小梁切除术研究

目的

描述主要管与小梁切除术 (PTVT) 研究的方法。

设计

多中心随机临床试验。

参与者

患有药物无法控制的青光眼且之前没有进行过切口眼部手术的患者。

方法

患者被纳入 16 个临床中心，并被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 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) 超过 21 mmHg 或从基线降低不到 20%、IOP ≤ 5 mmHg、青光眼再次手术或光感视力丧失。次要结果测量包括眼压、青光眼药物治疗、视力、视野和手术并发症。

结论

青光眼手术治疗的实践模式各不相同，外科医生对青光眼首选主要手术的意见也不同。PTVT 研究将提供有价值的信息，比较两种最常用的青光眼手术程序。