使用丝裂霉素C的小梁切除术与去细胞胶原蛋白植入物的比较：一项随机试验的临床结果和组织病理学发现

Trabeculectomy using mitomycin C versus an atelocollagen implant: clinical results of a randomized trial and histopathologic findings.

作者信息

Rosentreter André, Gaki Stergiani, Cursiefen Claus, Dietlein Thomas S

机构信息

Center of Ophthalmology, University of Cologne, Cologne, Germany.

出版信息

Ophthalmologica. 2014;231(3):133-40. doi: 10.1159/000356400. Epub 2013 Dec 24.

DOI:10.1159/000356400

PMID:24401481

Abstract

PURPOSE

To assess the efficacy of trabeculectomy with a biodegradable Ologen™ implant (OLO) versus mitomycin C (MMC) in patients in a prospective randomized clinical trial.

METHODS

In the MMC group (15 patients), trabeculectomy was performed according to standard protocols. In the OLO group (15 patients) after standard trabeculectomy, the implant was positioned on top of the scleral flap, and no MMC was applied.

RESULTS

Mean preoperative intraocular pressure (IOP) levels (OLO: 28.0 ± 9.4; MMC: 23.9 ± 5.0 mm Hg; p = 0.21) and medication score (OLO: 3.4 ± 1.6; MMC: 3.6 ± 1.5; p = 0.56) were comparable in both groups. One year after surgery, the mean IOP was 15.9 ± 4.5 mm Hg in the OLO group (p < 0.01, 43% reduction) and 11.0 ± 2.6 mm Hg in the MMC group (p < 0.01, 54% reduction). The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01).

CONCLUSIONS

With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group.

摘要

目的

在一项前瞻性随机临床试验中，评估采用可生物降解的Ologen™植入物（OLO）与丝裂霉素C（MMC）进行小梁切除术对患者的疗效。

方法

MMC组（15例患者）按照标准方案进行小梁切除术。OLO组（15例患者）在标准小梁切除术后，将植入物放置在巩膜瓣上方，未应用MMC。

结果

两组术前平均眼压水平（OLO组：28.0±9.4；MMC组：23.9±5.0 mmHg；p = 0.21）和用药评分（OLO组：3.4±1.6；MMC组：3.6±1.5；p = 0.56）具有可比性。术后一年，OLO组平均眼压为15.9±4.5 mmHg（p < 0.01，降低43%），MMC组为11.0±2.6 mmHg（p < 0.01，降低54%）。术后12个月，MMC组手术成功率为93.3%，OLO组为40%（p = 0.01）。