Pillunat Karin R, Herber Robert, Jamke Melanie, Jasper Carolin S, Haase Maike A, Manseck Anna S, Pillunat Lutz E
Department of Ophthalmology, Medical Faculty Carl Gustav Carus, Technische Universität, Fetscherstrasse, Dresden, Germany.
J Glaucoma. 2025 Feb 1;34(2):103-113. doi: 10.1097/IJG.0000000000002509. Epub 2024 Oct 11.
The Preserflo MicroShunt effectively lowered intraocular pressure in primary high and normal pressure open angle glaucoma.
To evaluate the efficacy and safety of the Preserflo MicroShunt in patients with primary open angle glaucoma (POAG) and the 2 variants high (HPG) and normal pressure glaucoma (NPG) after 1 year.
Single-center prospective interventional case series consecutively including eyes of White/European patients with POAG, who received the Preserflo MicroShunt as a primary and standalone glaucoma intervention. Primary outcome measures: change in mean 24-hour IOP (mdIOP, mean of 6 measurements), peak IOP, IOP fluctuations, antiglaucoma medications, and success rates. Secondary outcome measures include visual acuity, visual fields, complications, surgical interventions, and adverse events.
Forty-two eyes of 42 patients with POAG, 29 in the HPG and 13 in the NPG group, were analyzed after 1-year follow-ups. Median [Q25, Q75] medicated mdIOP (mm Hg) dropped by 30% from 16.5 [13.7-27.3] to 12.8 [10.2-14.5] in the HPG and by 40% from 14.3 [13.3-16.0] to 9.5 [8.3-11.1] in the NPG group, with a median postoperative medication use of 0 [0-0] in both groups. At 1 year, 92.5% of eyes were medication-free versus 0% preoperatively. The reduction of mdIOP ( P =1.0), peak IOP ( P =0.932), IOP fluctuations ( P =0.142), and the rate of interventions ( P =0.298) were not statistically significantly different between the HPG and NPG group. None of the patients experienced severe adverse events or loss of vision.
Effective and safe intraocular pressure lowering was observed 1 year following MicroShunt implantation for primary HPG and NPG in White patients of European descent.
Preserflo微分流器可有效降低原发性高眼压和正常眼压性开角型青光眼的眼压。
评估Preserflo微分流器在原发性开角型青光眼(POAG)患者以及高眼压性青光眼(HPG)和正常眼压性青光眼(NPG)这两种变异类型患者中使用1年后的疗效和安全性。
单中心前瞻性干预性病例系列研究,连续纳入接受Preserflo微分流器作为原发性和独立青光眼干预措施的白种人/欧洲POAG患者的眼睛。主要结局指标:24小时平均眼压(mdIOP,6次测量的平均值)变化、眼压峰值、眼压波动、抗青光眼药物使用情况及成功率。次要结局指标包括视力、视野、并发症、手术干预及不良事件。
42例POAG患者的42只眼睛,其中HPG组29只,NPG组13只,在1年随访后进行分析。HPG组中,使用药物时mdIOP的中位数[四分位数间距Q25, Q75](mmHg)从16.5 [13.7 - 27.3]降至12.8 [10.2 - 14.5],降幅为30%;NPG组中从14.3 [13.3 - 16.0]降至9.5 [8.3 - 11.1],降幅为40%,两组术后药物使用中位数均为0 [0 - 0]。1年后,92.5%的眼睛无需使用药物,而术前这一比例为0%。HPG组和NPG组在mdIOP降低幅度(P = 1.0)、眼压峰值降低幅度(P = 0.932)、眼压波动(P = 0.142)以及干预率(P = 0.298)方面差异均无统计学意义。所有患者均未发生严重不良事件或视力丧失。
对于欧洲裔白种人的原发性HPG和NPG患者,在植入微分流器1年后观察到眼压降低有效且安全。