Posarelli Chiara, Figus Michele, Roberti Gloria, Giammaria Sara, Ghirelli Giorgio, Quercioli Pierpaolo, Micelli Ferrari Tommaso, Pace Vincenzo, Mastropasqua Leonardo, Agnifili Luca, Sacchi Matteo, Scuderi Gianluca, Perdicchi Andrea, Altafini Romeo, Uva Maurizio, D'Andrea Dino, Covello Giuseppe, Maglionico Maria Novella, Fea Antonio Maria, Carnevale Carmela, Oddone Francesco
Department of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, 56124 Pisa, Italy.
IRCCS Fondazione Bietti, 00198 Rome, Italy.
J Clin Med. 2022 Sep 9;11(18):5320. doi: 10.3390/jcm11185320.
The Italian XEN Glaucoma Treatment Registry (XEN-GTR) was created to acquire a comprehensive prospective dataset that includes the patient characteristics, intraoperative variables, and postoperative management of glaucoma patients undergoing the XEN gel stent implantation. This was a prospective observational, longitudinal clinical study involving 10 centres throughout Italy. The baseline examination included a comprehensive evaluation of demographic parameters (age, sex, ethnicity, and systemic condition), specific ophthalmological parameters, and quality of life questionnaire score collection. The baseline data of 273 patients were analysed. The median (IQR) age was 72 (65.0 to 78.0) years. Of the 273 patients, 123 (45%) were female and 150 (55%) were male. A total of 86% of the patients had open-angle glaucoma with a mean intraocular pressure of 24 ± 6 (range 12.0-60.0) mmHg. The mean number of medications was 2.7 ± 0.9 at baseline for the patients with a prevalence of prostaglandin analogues combined with a beta-blocker and anhydrase carbonic inhibitor (31.8%). The mean scores of the NEI-VFQ 25 and GSS questionnaires were 78 ± 18 (range 26.5-100) and 85 ± 14 (range 79-93), respectively. Combined XEN/cataract surgeries were scheduled in 73.7% of the patients. The preferred place for the XEN implant was the supero-nasal quadrant (91.6%). Observing the baseline characteristics of the typical Italian candidates for the XEN gel implant shows that they are patients affected by POAG and cataracts, with moderate to severe glaucoma damage, all of which has an impact on their quality of life.
意大利XEN青光眼治疗注册研究(XEN-GTR)旨在获取一个全面的前瞻性数据集,该数据集包括接受XEN凝胶支架植入术的青光眼患者的特征、术中变量和术后管理情况。这是一项前瞻性观察性纵向临床研究,涉及意大利各地的10个中心。基线检查包括对人口统计学参数(年龄、性别、种族和全身状况)、特定眼科参数以及生活质量问卷评分的全面评估。对273例患者的基线数据进行了分析。年龄中位数(四分位间距)为72(65.0至78.0)岁。在这273例患者中,123例(45%)为女性,150例(55%)为男性。共有86%的患者患有开角型青光眼,平均眼压为24±6(范围12.0 - 60.0)mmHg。基线时,前列腺素类似物联合β受体阻滞剂和碳酸酐酶抑制剂的患者平均用药数量为2.7±0.9(患病率为31.8%)。NEI-VFQ 25问卷和GSS问卷的平均得分分别为78±18(范围26.5 - 100)和85±14(范围79 - 93)。73.7%的患者计划进行XEN/白内障联合手术。XEN植入的首选部位是鼻上象限(91.6%)。观察典型的意大利XEN凝胶植入术候选患者的基线特征表明,他们是患有原发性开角型青光眼和白内障、青光眼损害程度为中度至重度的患者,所有这些均对其生活质量产生影响。