Tanna Angelo P, Rademaker Alfred W, de Moraes C Gustavo, Godfrey David G, Sarkisian Steven R, Vold Steven D, Ritch Robert
Department of Ophthalmology, Northwestern University Feinberg School of Medicine, 645 N. Michigan Ave., Suite 440, Chicago, IL, 60611, USA.
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
BMC Ophthalmol. 2016 Dec 29;16(1):217. doi: 10.1186/s12886-016-0393-z.
Antifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM).
A prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ≤21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events.
The baseline IOPs were 20.4 ± 6.0 mmHg and 21.2 ± 6.1 (mean ± standard deviation, p = 0.49) on 3.2 ± 1.1 and 3.1 ± 1.0 medications (p = 0.53) compared to 11.8 ± 5.2 and 12.8 ± 3.7 (p = 0.36) on 0.5 ± 0.8 and 0.6 ± 1.0 medications (p = 0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4 ± 7.6% with MMC and 56.2 ± 7.9% with CM (mean ± standard error, p = 0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC (p = 0.002).
Use of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC.
ClinicalTrials.gov registration number NCT01440751 . Registered 9/14/11.
抗纤维化药物常用于提高小梁切除术的成功率。需要新的方法来进一步提高成功率并降低并发症风险。本研究的目的是比较小梁切除术或白内障超声乳化联合小梁切除术联合丝裂霉素C（MMC）与胶原基质（CM）降低眼压（IOP）的疗效和安全性。
进行了一项前瞻性、多中心、随机对照试验。94例尽管接受药物治疗但青光眼仍未得到控制且既往未行切开性青光眼手术的患者的95只眼接受了小梁切除术（85只眼）或白内障超声乳化联合小梁切除术（10只眼），并随机分为MMC组或CM组。对每个受试者的一只眼睛进行分析。患者随访24个月。完全成功的标准是眼压>5且≤21mmHg，比药物治疗基线至少降低20%，无需额外的青光眼手术或药物治疗。主要观察指标是24个月时的完全成功率（采用Kaplan-Meier分析）和不良事件发生率。
MMC组和CM组2年时的基线眼压分别为20.4±6.0mmHg和21.2±6.1mmHg（均值±标准差，p = 0.49），使用的药物分别为3.2±1.1种和3.1±1.0种（p = 0.53）；相比之下，2年时眼压分别为11.8±5.2mmHg和12.8±3.7mmHg（p = 0.36），使用的药物分别为0.5±0.8种和0.6±1.0种（p = 0.63）。Kaplan-Meier分析显示，两组在24个月时的完全成功率相似：MMC组为38.4±7.6%，CM组为56.2±7.9%（均值±标准误，p = 0.112，对数秩检验）；然而，MMC组因持续性低眼压导致失败的发生率显著更高（p = 0.002）。
小梁切除术或白内障超声乳化联合小梁切除术时使用CM植入物与辅助使用MMC的完全成功率相似；然而，MMC导致持续性低眼压的风险更高。
ClinicalTrials.gov注册号NCT01440751。于2011年9月14日注册。
