Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.
USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.
Am J Ophthalmol. 2020 Dec;220:45-52. doi: 10.1016/j.ajo.2020.07.002. Epub 2020 Jul 6.
To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy.
Prospective, randomized, interventional study.
This study took place in a single clinical practice in an academic setting. Patients had medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy was indicated. Patients were older than 18 years with medically uncontrolled glaucoma and no history of incisional glaucoma surgery. Patients were randomized to MMC delivered by preoperative subconjunctival injection or by intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at 1 day, 1 week, 6 weeks, 3 months, and 6 months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed. The primary outcome was the proportion of patients who demonstrated IOP of <21 mm Hg and ≥30% reduction in IOP from baseline. Secondary outcome measures included the number of IOP-lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates.
Participants (n = 100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At 6 months, there were no significant differences between the injection (n = 38) and sponge (n = 40) groups in surgical success (P = .357), mean IOP (P = .707), number of glaucoma medications (P = 1.000), bleb height (P = .625), bleb extension (P = .216), bleb vascularity (P = .672), or complications rates.
Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.
比较术中巩膜应用与结膜下注射丝裂霉素 C（MMC）在小梁切除术治疗中的疗效。
前瞻性、随机、干预性研究。
本研究在一家学术医疗机构的单一临床实践中进行。患者的高眼压（IOP）、视野恶化或视神经头改变表明患有药物无法控制的青光眼，需要进行原发性小梁切除术。患者年龄大于 18 岁，患有药物无法控制的青光眼，且无切口性青光眼手术史。患者随机分为术前结膜下注射 MMC 组或术中直接用手术海绵在巩膜上应用 MMC 组。术后 1 天、1 周、6 周、3 个月和 6 个月进行全面的眼部检查。根据需要，术后给予结膜下注射 5-氟尿嘧啶。主要结局是IOP<21mmHg 且IOP 较基线降低≥30%的患者比例。次要结局指标包括眼压降低药物的数量、采用印第安纳滤过泡外观分级量表评估的滤过泡形态和并发症发生率。
参与者（n=100）按基线人口统计学、青光眼状况和基线 IOP 进行随机分组，两组匹配。6 个月时，注射组（n=38）和海绵组（n=40）在手术成功率（P=.357）、平均 IOP（P=.707）、降眼压药物数量（P=1.000）、滤过泡高度（P=.625）、滤过泡延伸（P=.216）、滤过泡血管化（P=.672）或并发症发生率方面无显著差异。
两种 MMC 给药技术（结膜下注射和直接巩膜应用）都产生了类似的手术效果和滤过泡形态。
