Abstract

Purpose

The aim of this study was to determine whether glaucoma patients after trabeculectomy could benefit more from subconjunctival injections of bevacizumab than 5-FU or placebo.

Methods and results

Fifty-one eyes of 51 patients were recruited for primary MMC (0.2 mg/mL for 1 min) augmented trabeculectomy. 17 patients were randomly assigned to receive 1.25 mg (0.05 mL) of bevacizumab augmentation, 21 patients were assigned to receive 0.1 mL of 50 mg/mL 5-FU and 13 patients were assigned to a control group receiving a normal saline injection as a placebo. Initial recruitment included 58 patients, but seven patients had to be excluded from the study for various reasons. Postoperative follow up of IOP and bleb characteristics was carried out at 1 day, 1 week, 3 weeks, 6 weeks, 6 months and 1 year after surgery. All analyses where carried out by two masked clinicians. IOP reduction was statistically significant (p < 0.05) across all three groups between baseline visit and final 1-year postoperative visit. There was no significant difference of the final average IOP values between the three groups. Bleb evaluation was made using the Moorfields bleb grading system (MBGS) after 1 year follow up. Central bleb area was statistically greater in the Bevacizumab group when compared with the 5-FU group but not with the placebo group. The vascularity of the central bleb was significantly different between the groups with the Bevacizumab group showing the least vascularity. Vascularity of the peripheral bleb was also decreased in the Bevacizumab group when compared with the placebo group but not with the 5-FU group.

Conclusion

The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy. However, by the analysis of bleb morphology there was a significant difference in terms of central bleb area and vascularity.

中文翻译：

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评估在初级小梁切除术中使用贝伐珠单抗、5-氟尿嘧啶或安慰剂后的安全性和成功率。前瞻性随机安慰剂对照 1 年随访研究

摘要

目的

本研究的目的是确定小梁切除术后青光眼患者结膜下注射贝伐珠单抗是否比 5-FU 或安慰剂获益更多。

方法和结果

招募了 51 名患者的 51 只眼进行初级 MMC（0.2 mg/mL，持续 1 分钟）增强小梁切除术。17 名患者被随机分配接受 1.25 mg（0.05 mL）贝伐珠单抗增强治疗，21 名患者被分配接受 0.1 mL 50 mg/mL 5-FU，13 名患者被分配到接受生理盐水注射作为安慰剂的对照组. 初始招募包括 58 名患者，但由于各种原因不得不将 7 名患者排除在研究之外。术后1天、1周、3周、6周、6个月和1年进行眼压和眼泡特征的术后随访。所有分析均由两名蒙面临床医生进行。眼压降低具有统计学意义 ( p < 0.05) 在所有三组之间基线访问和最后 1 年术后访问之间。三组间最终平均眼压值无显着差异。随访 1 年后，使用 Moorfields 疱疹分级系统 (MBGS) 进行疱疹评估。与 5-FU 组相比，贝伐珠单抗组的中心泡面积在统计学上更大，但与安慰剂组相比则不然。中心泡的血管分布在各组之间有显着差异，贝伐珠单抗组显示出最少的血管分布。与安慰剂组相比，贝伐珠单抗组外周大泡的血管分布也有所减少，但与 5-FU 组相比则没有。

结论

12 个月的 IOP 结果显示，在贝伐珠单抗、5-FU 或安慰剂增强原发性 MMC 增强小梁切除术后，各组患者之间没有显着差异。然而，通过泡形态学分析，在中央泡面积和血管分布方面存在显着差异。