Alzahra Eye Hospital Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.
Department of Nutrition, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.
Int Ophthalmol. 2023 Nov;43(11):4225-4233. doi: 10.1007/s10792-023-02833-9. Epub 2023 Aug 10.
To investigate the long-term efficacy and safety of the novel method sutureless trabeculectomy with topical administration of bevacizumab.
MATERIALS/METHODS: Primary open-angle glaucoma patients with intraocular pressure (IOP) > 21 mmHg despite maximum tolerated medication were included in a single-blind prospective interventional clinical trial. Group 1 underwent sutureless scleral tunnel trabeculectomy with intraoperative topical administration of bevacizumab (1.25 mg) applied on the scleral incision for 1 min. Group 2 underwent sutureless trabeculectomy alone and group 3 (control group) underwent conventional trabeculectomy with mitomycin C (MMC). Outcome measures were surgical success, IOP, number of needed anti-glaucoma medications, and complications. Patients were followed for two years.
Finally, 50 eyes from group 1, 46 from group 2, and 47 from group 3 were analyzed. At the end of 24 months, 52% (n = 26) of group 1, 34.8% (n = 16) of group 2, and 57.4% (n = 27) of group 3 had complete success (IOP < 18 mmHg without medication). The difference was only significant between groups 2 and 3 (p = 0.003). 94% (n = 47) of group 1, 89.1% (n = 41) of group 2, and 91.5% (n = 43) of group 3 had qualified success (IOP < 18 mmHg with ≤ 2 anti-glaucoma medications) (p = 0.69). There was a significant difference in the overall IOP mean between the three groups (p < 0.0001). There was no significant difference between the three groups in complication rates and the number of needed anti-glaucoma medications for IOP control.
Sutureless trabeculectomy with topical application of bevacizumab showed comparable surgical success rates with conventional trabeculectomy and MMC in long-term follow-up. Additionally, adjuvant use of topical bevacizumab had a significant positive impact on long-term IOP control.
研究新型无缝线小梁切除术联合贝伐单抗局部给药治疗开角型青光眼的长期疗效和安全性。
材料/方法：本单盲前瞻性干预性临床试验纳入了眼压（IOP）＞21mmHg且最大耐受药物治疗仍未达标的原发性开角型青光眼患者。1 组患者行无缝线巩膜隧道小梁切除术，术中在巩膜切口上局部应用贝伐单抗（1.25mg），持续 1 分钟。2 组患者行无缝线小梁切除术，3 组（对照组）患者行丝裂霉素 C（MMC）常规小梁切除术。主要观察指标为手术成功率、IOP、抗青光眼药物的使用次数和并发症。所有患者均随访 2 年。
最终，1 组 50 只眼、2 组 46 只眼、3 组 47 只眼纳入分析。24 个月时，1 组完全成功率为 52%（n=26），2 组为 34.8%（n=16），3 组为 57.4%（n=27），差异仅在 2 组和 3 组之间具有统计学意义（p=0.003）。1 组 94%（n=47），2 组 89.1%（n=41），3 组 91.5%（n=43）的患者达到了合格的手术成功率（IOP＜18mmHg且≤2 种抗青光眼药物）（p=0.69）。3 组患者的总体 IOP 平均值差异有统计学意义（p＜0.0001）。3 组患者的并发症发生率和眼压控制所需抗青光眼药物数量差异无统计学意义。
长期随访中，无缝线小梁切除术联合贝伐单抗局部给药的手术成功率与传统小梁切除术和丝裂霉素 C 相当。此外，局部应用贝伐单抗可显著改善长期 IOP 控制。
