Objective: To evaluate the efficacy and safety of glaucoma drainage implants(XEN-45 Gel Stent) for glaucoma treatment. Methods: A prospective study was conducted to continuously collect the clinical data of patients who were diagnosed with glaucoma and underwent XEN-45 Gel Stent implantation in the Ophthalmology Department of Peking University People's Hospital from January 2022 to August 2023. The visual acuity, intraocular pressure, number of glaucoma medications, and success rate of the patients were analyzed before and after surgery at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, and 18 months. The differences in intraocular pressure and number of glaucoma medications among primary open-angle glaucoma, primary angle closure glaucoma, secondary glaucoma, and different implantation methods of XEN-45 Gel Stent among patients with primary open-angle glaucoma were compared. The intraoperative and postoperative complications were observed, and the risk factors for needling and surgical complete success were analyzed. Results: A total of 48 eyes from 48 patients were included in this study, comprising 27 males and 21 females, with a mean age of (54.4±18.0) years and the disease duration was 36.0(7.3, 81.0) months.There were 28 cases of primary open-angle glaucoma, 4 cases of primary angle closure glaucoma, and 16 cases of secondary glaucoma.The follow-up period was 8.0 (3.0, 12.0) months. At 12 months after surgery, the intraocular pressure decreased from 20.5 (17.0, 26.0) mmHg to (13.5±3.3) mmHg (P<0.05), and the number of glaucoma medications decreased from 3.0 (3.0, 4.0) to 0.0 (0.0, 0.0) (P<0.05). The complete success rate and qualified success rate were 73.9% (17/23) and 91.3% (21/23), respectively. The most common postoperative complications were shallow anterior chamber in 6 cases (12.5%), hypotony in 3 cases (6.3%), and blocked stent in 3 cases (6.3%). The most common postoperative treatment was needling in 27 cases (56.3%). There was no significant difference in intraocular pressure among different types of glaucoma. In the comparison of postoperative effects of different surgical implantation methods for primary open-angle glaucoma, there were no statistically significant differences in intraocular pressure and the number of glaucoma medications at other follow-up time points except 1 month after surgery (P<0.05). Univariate logistic regression analysis did not find any risk factors associated with needling and surgical complete success. Conclusions: XEN-45 Gel Stent implantation is an effective and safe surgical option for different types of glaucoma patients in China, which can significantly reduce intraocular pressure and the use of glaucoma medications and has a high success rate. However, some patients may need needling or other treatments after surgery.
目的： 评估青光眼引流管（XEN-45凝胶引流管）治疗青光眼的有效和安全性。 方法： 前瞻性研究。连续纳入从2022年1月至2023年8月于北京大学人民医院眼科被诊断为青光眼且行XEN-45凝胶引流管植入术的患者。收集患者术前及术后1 d、1周、1个月、3个月、6个月、12个月、18个月的视力、眼压、降眼压用药药物数量以及手术成功率情况，并比较原发性开角型青光眼（POAG）、原发性闭角型青光眼（PACG）、继发性青光眼（SG）3种类型青光眼各项指标，以及不同XEN-45凝胶引流管植入方式的POAG患眼手术前后眼压和降眼压用药药物数量的差异。观察患者术中和术后的并发症，采用单因素Logistic回归的方法分析针拨滤过泡及手术完全成功的相关因素。 结果： 共纳入青光眼患者48例（48只眼），包括男性27例、女性21例；年龄为（54.4±18.0）岁；病程为36.0（7.3，81.0）个月。其中POAG 28只眼、PACG 4只眼、SG 16只眼。随访8.0（3.0，12.0）个月。术后12个月时，其术前眼压由20.5（17.0，26.0）mmHg（1 mmHg=0.133 kPa）下降至（13.5±3.3）mmHg（P<0.05），降眼压用药药物数量由3.0（3.0，4.0）种减少至0.0（0.0，0.0）种（P<0.05），完全成功率、条件成功率分别为73.9%（17/23）和91.3%（21/23）。术后常见并发症为浅前房6例（12.5%），其次有一过性低眼压（<6 mmHg）3例（6.3%）、内口阻塞3例（6.3%），最常见的并发症处理为针拨滤过泡27例（56.3%）。不同青光眼类型在XEN-45凝胶引流管植入术后眼压的差异无统计学意义（P>0.05）；在原发性开角型青光眼使用不同手术植入方法的术后效果比较中，除术后1个月时眼压差异存在统计学意义（P<0.05）外，其他随访时间点的眼压和降眼压用药药物数量的差异均无统计学意义（P>0.05）。未发现与针拨滤过泡及手术完全成功相关的危险因素。 结论： XEN-45 凝胶引流管植入术对于我国不同青光眼类型患者是一种有效且安全的手术方式，可以显著降低眼压和降眼压用药药物数量，且具有较高的手术成功率，但部分患者术后可能需要针拨滤过泡等处理。.