Department of Ophthalmology, University of Colorado Denver School of Medicine, Rocky Mountain Lions Eye Institute, 1675 Aurora Court, Aurora, CO 80045, USA.
Am J Ophthalmol. 2010 Sep;150(3):399-403.e1. doi: 10.1016/j.ajo.2010.03.025. Epub 2010 Jun 8.
To investigate outcomes after trabeculectomy using intraoperative intravitreal ranibizumab and topical mitomycin C (MMC) vs MMC alone.
Prospective randomized single-site pilot study.
Patients diagnosed with primary open-angle glaucoma were randomized 1:1 to either combination intravitreal ranibizumab 0.5 mg and topically applied MMC (0.4 mg/mL for 2 min) or MMC (0.4 mg/mL for 2 min) therapy alone at time of trabeculectomy surgery. The primary endpoint measured was bleb morphology and vascularity using the Moorfields Bleb Grading System. Unqualified success was defined as postoperative intraocular pressure (IOP) of >5 and <22 mm Hg and a 30% decrease from baseline without use of postoperative hypotensive drops. Qualified success was defined as postoperative IOP of >5 and <22 mm Hg and a 30% decrease from baseline with use of postoperative hypotensive drops.
Ten patients were randomized to either standard trabeculectomy with MMC (Group A) or trabeculectomy with intravitreal ranibizumab and MMC (Group B). All patients completed the study and were classified as unqualified successes. There were statistically significant differences in peripheral bleb area (P = .02), peripheral bleb vascularity (P = .02), and non-bleb-related peripheral conjunctiva vascularity (P = .0003), with Group B exhibiting more diffuse blebs with a lower degree of vascularity.
Combination intravitreal ranibizumab and topical MMC at time of trabeculectomy resulted in more diffuse blebs with less vascularity when compared to use of topical MMC alone. Further studies are planned to better understand the utility of anti-vascular endothelial growth factor agents as modulators of wound healing post trabeculectomy.
研究术中玻璃体内雷珠单抗联合局部丝裂霉素 C（MMC）与单独使用 MMC 行小梁切除术的效果。
前瞻性随机单中心试点研究。
诊断为原发性开角型青光眼的患者按 1:1 比例随机分为两组，一组行小梁切除术中玻璃体内雷珠单抗 0.5mg 联合局部应用 MMC（0.4mg/mL 持续 2 分钟），另一组单独行 MMC（0.4mg/mL 持续 2 分钟）治疗。主要观察终点为采用 Moorfields 滤过泡分级系统评估滤过泡形态和血管化。未达标成功定义为术后眼内压（IOP）>5mmHg 且<22mmHg，与基线相比降低 30%，且未使用术后降压眼药水；达标成功定义为术后 IOP>5mmHg 且<22mmHg，与基线相比降低 30%，且使用术后降压眼药水。
10 例患者随机分为标准小梁切除术联合 MMC 组（A 组）或小梁切除术联合玻璃体内雷珠单抗和 MMC 组（B 组）。所有患者均完成了研究，被归类为未达标成功。B 组周边滤过泡面积（P=.02）、周边滤过泡血管化（P=.02）和非滤过泡相关的周边结膜血管化（P=.0003）显著低于 A 组，B 组的滤过泡更弥散，血管化程度更低。
与单独使用局部 MMC 相比，小梁切除术中联合玻璃体内雷珠单抗和局部 MMC 可使滤过泡更弥散，血管化程度更低。计划开展进一步的研究，以更好地了解抗血管内皮生长因子药物作为小梁切除术后伤口愈合调节剂的作用。
