Martínez-de-la-Casa José María, Pascual-Santiago Antonio, Morales-Fernandez Laura, Saez-Frances Federico, Garcia-Saenz Sofia, Guemes-Villahoz Noemi, Sanchez-Jean Ruben, Mendez Carmen, Garcia-Feijoo Julian
Department of Ophthalmology and ORL, Faculty of Medicine, Clinico San Carlos Hospital, Complutense University, Clinico San Carlos Hospital Health Research Institute (IdISSC), Calle del Prof Martín Lagos, s/n,, Madrid, 28040, Spain.
Sci Rep. 2025 Jan 10;15(1):1634. doi: 10.1038/s41598-024-81616-3.
This study compared the efficacy safety profiles of the Xen 63 and Preserflo MicroShunt devices, both standalone, in patients with primary open-angle glaucoma (POAG). It is a retrospective and single-center study conducted on consecutive on patients with medically uncontrolled POAG who underwent either a standalone Xen 63 or a standalone Preserflo and had a 12-month follow-up visit. The primary outcome was the mean IOP at month-12. Sixty eyes were included, 30 eyes in each Xen 63 and Preserflo groups, respectively. Preoperative IOP was significantly lowered from 20.8 ± 3.6 mmHg and 19.1 ± 3.8 mmHg to 14.2 ± 4.5 mmHg and 12.8 ± 2.3 mmHg in the Xen 63 and Preserflo groups, respectively (p < 0.0001 each, respectively); without significant differences between groups (p = 0.1346). Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.6 to 0.2 ± 06 drugs and from 2.3 ± 0.7 to 0.3 ± 0.6 drugs, in the Xen 63 and Preserflo groups, respectively (p < 0.0001 each, respectively); without significant differences between groups (p = 0.5212). Regarding safety, one (3.3%) eye in the Preserflo group required a device removal due to maculopathy. Three (10.0%) eyes in the Xen 63 group underwent needling. In conclusion, both the Xen 63 and the Preserflo devices effectively and safely reduced IOP and the requirement for IOP-lowering medications, exhibiting comparable IOP levels after 12 months.
本研究比较了Xen 63和Preserflo MicroShunt装置单独使用时,在原发性开角型青光眼(POAG)患者中的疗效和安全性。这是一项回顾性单中心研究,对连续的药物治疗无法控制的POAG患者进行,这些患者接受了单独的Xen 63或单独的Preserflo治疗,并进行了12个月的随访。主要结局是12个月时的平均眼压。共纳入60只眼,Xen 63组和Preserflo组各30只眼。Xen 63组和Preserflo组的术前眼压分别从20.8±3.6 mmHg和19.1±3.8 mmHg显著降低至14.2±4.5 mmHg和12.8±2.3 mmHg(每组p均<0.0001);两组间无显著差异(p = 0.1346)。Xen 63组和Preserflo组的术前降眼压药物数量分别从2.3±0.6降至0.2±0.6种药物和从2.3±0.7降至0.3±0.6种药物(每组p均<0.0001);两组间无显著差异(p = 0.5212)。在安全性方面,Preserflo组有1只眼(3.3%)因黄斑病变需要取出装置。Xen 63组有3只眼(10.0%)进行了针刺。总之,Xen 63和Preserflo装置均有效且安全地降低了眼压以及降眼压药物的需求,在12个月后眼压水平相当。