Purpose

To describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up.

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

Surgical complications, reoperations for complications, visual acuity, and cataract progression.

Results

Early postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77)

Conclusions

A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.

中文翻译：

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5 年随访期间原管与小梁切除术研究的术后并发症

目的

描述5 年随访期间原管与小梁切除术 (PTVT) 研究中遇到的术后并发症。

设计

多中心随机临床试验。

参加者

共有 242 名医学上未控制的青光眼患者和既往未接受过眼部切开手术的 242 只眼，其中管组 125 名患者和小梁切除术组 117 名患者。

方法

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

主要观察指标

手术并发症、因并发症再次手术、视力和白内障进展。

结果

管组 24 例患者 (19%) 和小梁切除术组 40 例患者 (34%) 发生术后早期并发症（P  = 0.013）。管组 27 例 (22%) 和小梁切除术组 32 例 (27%) 出现术后晚期并发症（P  = 0.37）。管组 3 例患者 (2%) 和小梁切除术组 9 例患者 (8%) 观察到导致视力丧失和/或需要再次手术的严重并发症（P  = 0.11）。管组 65 例 (52%) 患者和小梁切除术组 52 例 (44%) 患者出现白内障进展（P  = 0.30）。手术并发症与较高的治疗失败率 ( P  = 0.61)、视力丧失 (P  = 1.00)，或白内障进展 ( P  = 0.77)

结论

在 PTVT 研究中观察到大量手术并发症，但大多数是短暂的和自限性的。MMC 小梁切除术后早期术后并发症的发生率高于管分流手术。随访 5 年后，两种手术的晚期术后并发症、严重并发症和白内障进展率相似。手术并发症不会增加治疗失败、视力丧失或白内障进展的风险。