Vahedian Zakieh, Mafi Mostafa, Fakhraie Ghasem, Zarei Reza, Eslami Yadollah, Ghadimi Hadi, Mohebbi Masomeh
*Glaucoma Service, Farabi Eye Hospital †Farabi Eye Hospital, Tehran, Iran.
J Glaucoma. 2017 Sep;26(9):829-834. doi: 10.1097/IJG.0000000000000741.
To compare the outcome of trabeculectomy using adjunctive intracameral bevacizumab versus intraoperative mitomycin C (MMC).
In this double-blind, randomized clinical trial 87 eyes of 87 patients with primary open-angle or pseudoexfoliation glaucoma were assigned to each treatment group (44 cases received 1.25 mg intracameral bevacizumab at the end of operation and in 43 cases MMC was applied during surgery). Success was defined as intraocular pressure (IOP) between 6 and 21 mm Hg and at least 30% IOP drop with (qualified) or without (complete) glaucoma medications without additional glaucoma surgery.
The follow-up time was 17.12±2.58 months in the bevacizumab group and 17.23±2.42 months in the MMC group (P=0.845). The preoperative IOP was 29.17±3.94 and 28.8±4.08 mm Hg in the bevacizumab and MMC groups, respectively (P=0.689). Last visit IOP was 17.41±3.11 mm Hg in the bevacizumab group and 15.34±3.62 mm Hg in the MMC group (P<0.009). Compared with baseline, IOP drop at last visit was 11.76±5.51 and 13.43±5.92 in the bevacizumab and MMC groups, respectively (P=0.207). At last visit, complete success was achieved in 25 cases (61%) of bevacizumab group and 23 cases (66%) of MMC group (P=0.669). Early filtering bleb leak was more prevalent in bevacizumab group (29% vs. 11%).
A single 1.25 mg dose of intracameral bevacizumab improves the success of trabeculectomy comparable with MMC; however, it increases the risk of early filtering bleb leakage.
比较小梁切除术联合前房内注射贝伐单抗与术中应用丝裂霉素C(MMC)的疗效。
在这项双盲随机临床试验中,87例原发性开角型或假性剥脱性青光眼患者的87只眼被分配到各治疗组(44例在手术结束时接受1.25mg前房内贝伐单抗注射,43例在手术中应用MMC)。成功定义为眼压(IOP)在6至21mmHg之间,且在使用(合格)或不使用(完全)青光眼药物且无需额外青光眼手术的情况下眼压至少降低30%。
贝伐单抗组随访时间为17.12±2.58个月,MMC组为17.23±2.42个月(P=0.845)。贝伐单抗组和MMC组术前眼压分别为29.17±3.94和28.8±4.08mmHg(P=0.689)。末次随访时,贝伐单抗组眼压为17.41±3.11mmHg,MMC组为15.34±3.62mmHg(P<0.009)。与基线相比,末次随访时贝伐单抗组和MMC组眼压下降分别为11.76±5.51和13.43±5.92(P=0.207)。末次随访时,贝伐单抗组25例(61%)和MMC组23例(66%)达到完全成功(P=0.669)。早期滤过泡渗漏在贝伐单抗组更常见(29%对11%)。
单次1.25mg剂量的前房内贝伐单抗可提高小梁切除术的成功率,与MMC相当;然而,它增加了早期滤过泡渗漏的风险。