Post Michał, Lubiński Wojciech, Śliwiak Dominik, Podborączyńska-Jodko Karolina, Mularczyk Maciej
2nd Chair and Department of Ophthalmology, Pomeranian Medical University in Szczecin, Al. Powstańców Wlkp. 72, 70-111, Szczecin, Poland.
Chair and Department of Human and Clinical Anatomy, Pomeranian Medical University in Szczecin, Al. Powstańców Wlkp. 72, Szczecin, 70-111, Poland.
Doc Ophthalmol. 2020 Aug;141(1):65-76. doi: 10.1007/s10633-020-09753-4. Epub 2020 Feb 12.
To assess the efficacy and safety of the XEN Gel Stent in patients with primary open-angle glaucoma.
Twenty eyes of 17 patients (6 males, 11 females) with primary open-angle glaucoma were implanted with XEN Gel Stent. The following data were ascertained in each participant at baseline and at 1, 3, 6, 9 and 12 months following implanting procedure: intraocular pressure, number of anti-glaucoma medications, retinal sensitivity (PS 24/2 w/w), pattern electroretinogram (ISCEV standard), as well as the number of complications.
The mean intraocular pressure reduction in a 1-year follow-up was 18% (21.56 vs. 17.69 mmHg, p < 0.001). The mean number of anti-glaucoma medications was reduced from 3.2 to 1.6 (p = 0.001). The PERG parameters at baseline and at 12 months postoperatively included a stable amplitude of P50 (2.55 µV vs. 2.65 µV, p = 0.024) and N95 (3.45 µV vs. 3.38 µV, p = ns) waves. The delta N95 and delta P50 amplitudes remained stable over the follow-up period (p = ns). The mean deviation (MD) of PS 24/2 was - 6.54 dB vs. - 8.43 dB, p = ns, whereas the pattern standard deviation (PSD) was 6.18 dB vs. 6.91 dB, p = ns. Transient hypotony within the first postoperative week occurred in 18 eyes (90%), whereas hyphema occurred in two eyes (10%). Needle revision of a filtration bleb was performed in five eyes (25%).
The XEN Gel Stent enables significant reduction in intraocular pressure with very low complication rates. It ensures a stabilization of the retinal function as established with the PERG.
评估XEN凝胶支架治疗原发性开角型青光眼患者的疗效和安全性。
17例（6例男性，11例女性）原发性开角型青光眼患者的20只眼植入了XEN凝胶支架。在植入手术的基线期以及术后1、3、6、9和12个月，确定了每位参与者的以下数据：眼压、抗青光眼药物数量、视网膜敏感度（PS 24/2 w/w）、图形视网膜电图（ISCEV标准）以及并发症数量。
1年随访期间眼压平均降低18%（21.56 vs. 17.69 mmHg，p < 0.001）。抗青光眼药物的平均数量从3.2减少至1.6（p = 0.001）。基线期和术后12个月的图形视网膜电图参数包括P50波幅稳定（2.55 μV vs. 2.65 μV，p = 0.024）和N95波幅稳定（3.45 μV vs. 3.38 μV，p = 无统计学意义）。随访期间N95和P50波幅的变化幅度保持稳定（p = 无统计学意义）。PS 24/2的平均偏差（MD）为 -6.54 dB vs. -8.43 dB，p = 无统计学意义，而图形标准偏差（PSD）为6.18 dB vs. 6.91 dB，p = 无统计学意义。术后第一周内18只眼（90%）出现短暂性低眼压，2只眼（10%）出现前房积血。5只眼（25%）进行了滤过泡针刺修复。
XEN凝胶支架能显著降低眼压，并发症发生率极低。它可确保图形视网膜电图所显示的视网膜功能稳定。
