Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.
To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.
Multicenter, randomized clinical trial.
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.
Patients were enrolled at 16 clinical centers and assigned randomly to treatment with a tube shunt (350-mm Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes).
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).
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).
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.
报告原发性引流管与小梁切除术（PTVT）研究的 1 年治疗结果。
多中心、随机临床试验。
242 例 242 只眼的患者患有药物无法控制的青光眼，且无既往切口性眼外科手术史，包括 125 例引流管组和 117 例小梁切除术组。
患者在 16 个临床中心入组并随机分配接受引流管（350-mm Baerveldt 青光眼植入物）或小梁切除术联合丝裂霉素 C（MMC；0.4 mg/ml 持续 2 分钟）治疗。
眼内压（IOP）、青光眼药物治疗、视力、视野、手术并发症和失败（IOP 高于 21mmHg 或比基线值降低 20%以下、IOP 低于 5mmHg、因青光眼再次手术或光感视力丧失）。
在随访的第 1 年中，引流管组的累积失败率为 17.3%，小梁切除术组为 7.9%（P=0.01；风险比，2.59；95%置信区间，1.20-5.60）。引流管组平均±标准差 IOP 为 13.8±4.1mmHg，小梁切除术组为 12.4±4.4mmHg（P=0.01），且引流管组的青光眼药物数量为 2.1±1.4 种，小梁切除术组为 0.9±1.4 种（P<0.001）。引流管组有 36 例（29%）患者发生术后并发症，小梁切除术组有 48 例（41%）患者发生术后并发症（P=0.06）。引流管组有 1 例（1%）患者发生需要再次手术或导致 2 行 Snellen 视力表视力损失的严重并发症，小梁切除术组有 8 例（7%）患者发生（P=0.03）。
在 PTVT 研究中，1 年后小梁切除术联合丝裂霉素 C 的手术成功率高于引流管植入术。与引流管手术相比，小梁切除术联合丝裂霉素 C 在第 1 年随访期间能实现更低的 IOP，使用更少的青光眼药物。与小梁切除术联合丝裂霉素 C 相比，引流管手术后严重并发症导致视力丧失或需要再次手术的频率较低。
