Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Ophthalmology. 2022 Dec;129(12):1357-1367. doi: 10.1016/j.ophtha.2022.07.004. Epub 2022 Jul 12.
To describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up.
Multicenter randomized clinical trial.
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.
Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes).
Surgical complications, reoperations for complications, visual acuity, and cataract progression.
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.
描述原发性引流管与小梁切除术（PTVT）研究在 5 年随访期间发生的术后并发症。
多中心随机临床试验。
共有 242 例 242 只眼患有药物控制不良的青光眼且无既往切口性眼部手术史，包括 125 例引流管组和 117 例小梁切除术组患者。
患者在 16 个临床中心入组并随机分配接受引流管分流术（350-mm Baerveldt 青光眼植入物）或小梁切除术联合丝裂霉素 C（MMC，0.4mg/ml 持续 2 分钟）治疗。
手术并发症、并发症再手术、视力和白内障进展。
引流管组有 24 例（19%）和小梁切除术组有 40 例（34%）患者（P=0.013）发生早期术后并发症。引流管组有 27 例（22%）和小梁切除术组有 32 例（27%）患者（P=0.37）发生晚期术后并发症。引流管组有 3 例（2%）和小梁切除术组有 9 例（8%）患者（P=0.11）出现导致视力丧失和/或需要再次手术的严重并发症。引流管组有 65 例（52%）和小梁切除术组有 52 例（44%）患者（P=0.30）发生白内障进展。手术并发症与治疗失败率（P=0.61）、视力丧失（P=1.00）或白内障进展（P=0.77）无关。
PTVT 研究中观察到大量手术并发症，但大多数为短暂和自限性。与引流管分流术相比，小梁切除术联合丝裂霉素 C 术后早期并发症发生率更高。5 年随访后，两种手术方法的晚期术后并发症、严重并发症和白内障进展发生率相似。手术并发症并未增加治疗失败、视力丧失或白内障进展的风险。
