TVT 研究中青光眼再次手术的结果。
Outcomes of glaucoma reoperations in the Tube Versus Trabeculectomy (TVT) Study.
机构信息
Department of Ophthalmology, McGill University, Montreal, Quebec, Canada.
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
出版信息
Am J Ophthalmol. 2014 Jun;157(6):1179-1189.e2. doi: 10.1016/j.ajo.2014.02.027. Epub 2014 Feb 14.
PURPOSE
To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study.
DESIGN
Cohort study of patients in a multicenter randomized clinical trial.
METHODS
The TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. Randomization assigned 107 patients to surgery with a tube shunt (350 mm(2) Baerveldt glaucoma implant) and 105 patients to trabeculectomy with mitomycin C (0.4 mg/mL for 4 minutes). Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery. Outcome measures included intraocular pressure (IOP), use of glaucoma medications, visual acuity, surgical complications, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, additional glaucoma surgery, or loss of light perception vision).
RESULTS
Additional glaucoma surgery was performed in 8 patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study, and the 5-year cumulative reoperation rate was 9% in the tube group and 29% in the trabeculectomy group (P = .025). Follow-up (mean ± SD) after additional glaucoma surgery was 28.0 ± 16.0 months in the tube group and 30.5 ± 20.4 months in the trabeculectomy group (P = .76). At 2 years after a glaucoma reoperation, IOP (mean ± SD) was 15.0 ± 5.5 mm Hg in the tube group and 14.4 ± 6.6 mm Hg in the trabeculectomy group (P = .84). The number of glaucoma medications (mean ± SD) after 2 years of follow-up was 1.1 ± 1.3 in the tube group and 1.4 ± 1.4 in the trabeculectomy group (P = .71). The cumulative probability of failure at 1, 2, 3, and 4 years after additional glaucoma surgery was 0%, 43%, 43%, and 43%, respectively, in the tube group, and 0%, 9%, 20%, and 47% in the trabeculectomy group (P = .28). Reoperations to manage complications were required in 1 patient in the tube group and 5 patients in the trabeculectomy group (P = .63).
CONCLUSIONS
The rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin C than tube shunt surgery in the TVT Study. Similar surgical outcomes were observed after additional glaucoma surgery, irrespective of initial randomized treatment in the study.
目的
描述在 Tube Versus Trabeculectomy（TVT）研究中青光眼再次手术的发生率和结果。
设计
多中心随机临床试验的队列研究。
方法
TVT 研究纳入了 212 名患有经药物治疗仍无法控制的青光眼且既往行白内障和/或青光眼手术的患者。将 107 例患者随机分为管分流术（350mm² Baerveldt 青光眼植入物）组，105 例患者随机分为小梁切除术联合丝裂霉素 C 组（0.4mg/mL，4 分钟）。对未接受指定治疗且行额外青光眼手术的患者进行数据分析。观察指标包括眼内压（IOP）、青光眼药物使用、视力、手术并发症和失败（IOP＞21mmHg 或未降低 20%、IOP≤5mmHg、行额外青光眼手术或光感丧失）。
结果
在 TVT 研究中，管分流术组有 8 例患者和小梁切除术组有 18 例患者行额外青光眼手术，5 年累积再手术率分别为 9%和 29%（P=0.025）。管分流术组和小梁切除术组分别有 28.0±16.0 个月和 30.5±20.4 个月的时间进行额外青光眼手术后的随访（P=0.76）。青光眼再次手术后 2 年时，管分流术组的 IOP（均值±标准差）为 15.0±5.5mmHg，小梁切除术组为 14.4±6.6mmHg（P=0.84）。随访 2 年后，管分流术组和小梁切除术组的青光眼药物数量（均值±标准差）分别为 1.1±1.3 和 1.4±1.4（P=0.71）。额外青光眼手术后 1、2、3、4 年的累积失败概率分别为管分流术组 0%、43%、43%和 43%，小梁切除术组为 0%、9%、20%和 47%（P=0.28）。管分流术组有 1 例患者和小梁切除术组有 5 例患者需要行手术以处理并发症（P=0.63）。
结论
在 TVT 研究中，与管分流术相比，小梁切除术联合丝裂霉素 C 治疗青光眼的再手术率更高。在研究中，无论最初的随机治疗如何，接受额外青光眼手术后的手术结果相似。
Zotero 插件