Bertolani Yann, Rigo-Quera Jaume, Sánchez-Vela Laura, Pujol-Carreras Olivia, Amilburu Manuel, Dou Antonio, Castany Marta
Department of Ophthalmology, Vall d'Hebron University Hospital, 08035 Barcelona, Spain.
J Clin Med. 2025 May 19;14(10):3545. doi: 10.3390/jcm14103545.
: To compare the efficacy and safety of the XEN 63 µm and 45 µm devices with the ab externo open conjunctiva with a 30G needle approach. : A retrospective, non-randomized and single-center study was conducted. Consecutive eyes undergoing a XEN 63 µm implant were compared with a matched cohort of cases with a XEN 45 µm implant. Standalone and combined procedures with phacoemulsification were included. : A total of 28 XEN 45 µm and 28 XEN 63 µm were included. Complete surgical success was achieved in 17 cases (60.7%) in the 45 µm group and in 20 cases (71.4%) in the 63 µm group, with no statistical differences. One year after the surgery, the mean IOP was 13.8 ± 3.3 mmHg for the 45 µm group and 12.4 ± 4.2 mmHg for the 63 µm group (-value > 0.05). Likewise, the use of glaucoma medication was lowered in the 63 µm device (0.32 ± 0.87) compared to the 45 µm device (0.39 ± 0.86), with no statistical significance. Postoperative hypotony was more frequent in the 63 µm device (39.3%) than in the 45 µm group (28.6%), with no statistical differences. However, hypotony-associated complications (including choroidal detachment, hypotony keratopathy, and hypotony maculopathy) were significantly higher in the 63 µm group ( = 0.011). Although the XEN 63 µm may offer a greater IOP-lowering effect with better complete surgical success, no significant differences were detected compared to the 45 µm device. Hypotony-related complications were higher in the XEN 63 µm, although most of them resolved with conservative management.
为比较XEN 63 µm和45 µm装置经30G针经外眦开放结膜植入的疗效和安全性。：进行了一项回顾性、非随机单中心研究。将连续接受XEN 63 µm植入的眼睛与匹配的接受XEN 45 µm植入的病例队列进行比较。纳入了白内障超声乳化术的单独和联合手术。：共纳入28只接受XEN 45 µm植入的眼睛和28只接受XEN 63 µm植入的眼睛。45 µm组17例（60.7%）实现了完全手术成功，63 µm组20例（71.4%）实现了完全手术成功，无统计学差异。术后一年，45 µm组平均眼压为13.8±3.3 mmHg，63 µm组为12.4±4.2 mmHg（P值>0.05）。同样，与45 µm装置（0.39±0.86）相比，63 µm装置（0.32±0.87）的青光眼药物使用量有所降低，但无统计学意义。63 µm装置术后低眼压发生率（39.3%）高于45 µm组（28.6%），无统计学差异。然而，63 µm组低眼压相关并发症（包括脉络膜脱离、低眼压性角膜病变和低眼压性黄斑病变）显著更高（P = 0.011）。虽然XEN 63 µm可能具有更大的降眼压效果和更好的完全手术成功率，但与45 µm装置相比未发现显著差异。XEN 63 µm的低眼压相关并发症更高，尽管大多数通过保守治疗得以缓解。
