Oddone Francesco, Roberti Gloria, Giammaria Sara, Posarelli Chiara, Mastropasqua Leonardo, Agnifili Luca, Micelli Ferrari Tommaso, Pace Vincenzo, Sacchi Matteo, Altafini Romeo, Scuderi Gianluca, Perdicchi Andrea, Carnevale Carmela, Fea Antonio, Figus Michele
IRCCS-Fondazione Bietti, Via Livenza 6, 00198 Rome, Italy.
Department of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Via Savi 10, 56126 Pisa, Italy.
J Clin Med. 2024 Dec 3;13(23):7370. doi: 10.3390/jcm13237370.
: We evaluated the 3-year effectiveness and safety of XEN45, combined or not with phacoemulsification, in patients from the Italian XEN-Glaucoma Treatment Registry. : Data from glaucoma patients who underwent XEN45 alone or combined with phacoemulsification were analyzed. Changes in intraocular pressure (IOP) and the number of ocular hypotensive medications (OHMs) were tested with repeated measures ANOVA in last observation carried forward (LOCF) and per-protocol (PP) analyses. Complete and qualified success (IOP < 18 mmHg and ≥20% IOP reduction from baseline, without or with OHMs) at 36 months and pre- and intraoperative factors predicting surgery failure were explored using survival analysis and Cox proportional-hazard models. Complications rates were evaluated to assess safety. : The analysis included 239 eyes (239 patients): 144 (60.2%) in the XEN alone and 95 (39.8%) in the XEN+Phaco groups. Overall success was achieved in 164 (68.1%) eyes [113 (68.9%) complete and 51 (31.1%) qualified], without significant differences in success ( = 0.07) and survival rates ( = 0.46) between groups. At the 36th month, the baseline IOP decreased from a median (IQR) of 23.0 (20.0-26.0) to 15.0 (12.0-17.5) mmHg ( < 0.01), with an overall 34.1 ± 20.1% IOP reduction. The mean ± SD number of OHMs decreased from the baseline of 2.7 ± 0.9 to 0.9 ± 1.1 at month 36 ( < 0.01). PP and LOCF analyses were comparable. Neither pre- nor intraoperative factors were significantly predictive of surgery failure. In 91 (38.1%) and 57 (23.8%) of the eyes, at least one postoperative complication occurred early (<month 1) and late (≥month 1) during follow-up, respectively, without sequelae. During follow-up, 68 (28.5%) eyes needed at least one needling. At 3 years, XEN45, combined or not with phacoemulsification, effectively and safely reduced IOP and OHMs need.
我们在意大利XEN青光眼治疗登记处的患者中评估了XEN45单独或联合超声乳化手术的3年有效性和安全性。
分析了单独接受XEN45或联合超声乳化手术的青光眼患者的数据。采用末次观察结转（LOCF）和符合方案（PP）分析中的重复测量方差分析，对眼压（IOP）和降眼压药物（OHM）数量的变化进行了测试。使用生存分析和Cox比例风险模型，探讨了36个月时的完全成功和合格成功（IOP<18 mmHg且较基线降低≥20%，无论是否使用OHM）以及预测手术失败的术前和术中因素。评估并发症发生率以评估安全性。
分析纳入了239只眼（239例患者）：单独使用XEN组144只眼（60.2%），XEN+超声乳化组95只眼（39.8%）。164只眼（68.1%）取得了总体成功[113只眼（68.9%）完全成功，51只眼（31.1%）合格成功]，两组之间的成功率（P=0.07）和生存率（P=0.46）无显著差异。在第36个月时，基线眼压从中位数（IQR）23.0（20.0-26.0）mmHg降至15.0（12.0-17.5）mmHg（P<0.01），眼压总体降低34.1±20.1%。OHM的平均±标准差数量从基线的2.7±0.9降至第36个月时的0.9±1.1（P<0.01）。PP分析和LOCF分析结果相当。术前和术中因素均不能显著预测手术失败。分别有91只眼（38.1%）和57只眼（23.8%）在随访期间早期（<1个月）和晚期（≥1个月）至少发生了1次术后并发症，且无后遗症。在随访期间，68只眼（28.5%）需要至少1次针刺治疗。3年时，XEN45单独或联合超声乳化手术均能有效且安全地降低眼压和减少OHM的使用需求。
