IRCCS - Fondazione Bietti, Rome, Italy.
Department of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Pisa, Italy.
Eye (Lond). 2024 Jan;38(1):103-111. doi: 10.1038/s41433-023-02642-5. Epub 2023 Jul 6.
To evaluate the 1-year effectiveness and safety of the XEN45, either alone or in combination with phacoemulsification, in glaucoma patients.
This multicentre, prospective, observational study included consecutive eyes of glaucoma patients from the Italian XEN-Glaucoma Treatment Registry (XEN-GTR) who underwent XEN45 alone or in combination with phacoemulsification, with at least 1 year of follow-up. Surgical success was defined as intraocular pressure (IOP) < 18 mmHg and ≥20% reduction from preoperative IOP, over 1 year of follow-up.
Two hundred thirty-nine eyes (239 patients) were analyzed, 144 (60.2%) eyes in the XEN-solo and 95 (39.8%) eyes in the XEN+Phaco groups. One hundred-sixty-eight (70.3%) eyes achieved overall success, without statistically significant differences between study groups (p = 0.07). Preoperative IOP dropped from a median (IQR) of 23.0 (20.0-26.0) mmHg to 14.0 (12.0-16.0) mmHg at month 12 (p < 0.001), with overall 39.9 ± 18.3% IOP reduction. The mean number of preoperative ocular hypotensive medications (OHM) was significantly reduced from 2.7 ± 0.9 to 0.5 ± 0.9 at month 12 (p < 0.001). Preoperative IOP < 15 mmHg (HR: 6.63; 95%CI: 2.61-16.84, p < 0.001) and temporal position of the surgeon (HR: 4.25; 95%CI: 2.62-6.88, p < 0.001) were significantly associated with surgery failure. One hundred-forty-six (61.1%) eyes had no intraoperative complications, whereas 91 (38.1%) and 56 (23.4%) eyes experienced at least one complication, respectively early (< month 1) and late (≥ month 1), all self-limiting or successfully treated without sequelae. Needling occurred in 55 (23.0%) eyes at least once during follow-up.
Over 1-year follow-up, XEN45 alone or in combination with phacoemulsification, had comparable success rates and effectively and safely lowered IOP and the need for OHM.
评估 XEN45 单独或联合超声乳化术治疗青光眼患者的 1 年疗效和安全性。
这是一项多中心、前瞻性、观察性研究，纳入了意大利 XEN-Glaucoma Treatment Registry（XEN-GTR）中连续接受 XEN45 单独或联合超声乳化术治疗、随访至少 1 年的青光眼患者的连续眼。手术成功定义为：术后 1 年，眼压（IOP）<18mmHg 且较术前 IOP 降低≥20%。
共分析了 239 只眼（239 例患者），其中 XEN 组 144 只眼（60.2%），XEN+Phaco 组 95 只眼（39.8%）。168 只眼（70.3%）达到了总体成功，两组间无统计学差异（p=0.07）。术前 IOP 从中位数（IQR）23.0（20.0-26.0）mmHg 降至术后 12 个月的 14.0（12.0-16.0）mmHg（p<0.001），IOP 总体降低 39.9±18.3%。术前降眼压药物（OHM）的平均数量从 2.7±0.9 降至术后 12 个月的 0.5±0.9（p<0.001）。术前 IOP<15mmHg（HR：6.63；95%CI：2.61-16.84，p<0.001）和手术医生的位置（HR：4.25；95%CI：2.62-6.88，p<0.001）与手术失败显著相关。146 只眼（61.1%）术中无并发症，91 只眼（38.1%）和 56 只眼（23.4%）分别发生至少 1 次早期（<1 个月）和晚期（≥1 个月）并发症，均为自限性或无需后续治疗即成功治疗。55 只眼（23.0%）在随访期间至少接受过 1 次针刺治疗。
在 1 年的随访中，XEN45 单独或联合超声乳化术的成功率相当，可有效、安全地降低眼压和 OHM 的使用。
