Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
Department of Ophthalmology, University of Washington, Seattle, Washington.
Ophthalmology. 2018 May;125(5):774-781. doi: 10.1016/j.ophtha.2017.10.037. Epub 2017 Dec 18.
To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study.
Multicenter randomized clinical trial.
Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery.
Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes).
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.
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.
描述原发性引流管与小梁切除术（PTVT）研究的方法学。
多中心随机临床试验。
患有药物无法控制的青光眼且未进行过任何眼内切开手术的患者。
在 16 个临床中心招募患者，并随机分配至引流管（350-mm Baerveldt 青光眼植入物）或小梁切除术联合丝裂霉素 C（0.4mg/ml 持续 2 分钟）治疗。
主要观察指标为手术失败率，定义为眼压（IOP）超过 21mmHg 或较基线值降低不足 20%，IOP 为 5mmHg 或更低，因青光眼再次手术，或视力丧失。次要观察指标包括 IOP、青光眼药物治疗、视力、视野和手术并发症。
在青光眼的手术治疗中，实践模式存在差异，且外科医生对首选的原发性青光眼手术存在不同意见。PTVT 研究将提供有价值的信息，比较两种最常施行的青光眼手术。
