Department of Ophthalmology, University of Cologne, Köln, Germany.
Eye (Lond). 2010 Sep;24(9):1449-57. doi: 10.1038/eye.2010.106. Epub 2010 Aug 20.
The aim of this study is to assess the efficacy and complications of trabeculectomy with a biodegradable implant (ologen implant) vs trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open-angle glaucoma in a prospective randomised clinical trial.
In the MMC group (10 patients), trabeculectomy was performed according to standard protocols. In the ologen group (10 patients) after standard trabeculectomy the implant was positioned on top of the scleral flap and no MMC was applied. Follow-up was continued for 12 months after surgery and included testing of intraocular pressure (IOP), visual acuity, visual field, ultrasound biomicroscopy, and filtering bleb score.
The mean preoperative IOP was 24.8+/-8.9 mm Hg for all patients enrolled. At 1 year after surgery, the mean IOP was 15.6+/-2.4mm Hg in the ologen group (P<0.01, 43% reduction) and 11.5+/-4.1 mm Hg in the MMC group (P<0.01, 50% reduction). No anti-glaucomatous medication was necessary in the MMC group in the first year of follow-up, whereas five patients in the ologen group required topical treatment. The absolute success rate was 100% in the MMC group and 50% in the ologen group (P=0.01). After 1 year, filtering blebs developed significantly more avascular areas in the MMC group (score=1.4) than in the ologen group (score=2.8; P<0.01).
The complete success rate using trabeculectomy with the ologen implant is lower than that achieved by trabeculectomy with MMC. However, the bleb morphology caused more problems in the MMC group (avascularity score).
本研究旨在评估生物可降解植入物（奥洛根植入物）与丝裂霉素 C（MMC）在药物无法控制的开角型青光眼患者中行小梁切除术的疗效和并发症，这是一项前瞻性随机临床试验。
在 MMC 组（10 例）中，根据标准方案进行小梁切除术。在奥洛根组（10 例）中，在标准小梁切除术后，将植入物置于巩膜瓣顶部，不应用 MMC。术后继续随访 12 个月，包括眼压（IOP）、视力、视野、超声生物显微镜和滤过泡评分检测。
所有入组患者术前平均眼压为 24.8+/-8.9mmHg。术后 1 年，奥洛根组平均眼压为 15.6+/-2.4mmHg（P<0.01，降低 43%），MMC 组为 11.5+/-4.1mmHg（P<0.01，降低 50%）。在 MMC 组中，第一年无需使用抗青光眼药物，而在奥洛根组中，有 5 例需要局部治疗。MMC 组的绝对成功率为 100%，奥洛根组为 50%（P=0.01）。术后 1 年，MMC 组滤过泡中无血管区明显多于奥洛根组（评分 1.4 对 2.8；P<0.01）。
奥洛根植入物小梁切除术的完全成功率低于 MMC 小梁切除术。然而，MMC 组的滤过泡形态引起了更多的问题（无血管性评分）。
