María Pilar Bambó, Álvaro Tello, María José Vicente, Víctor Mallén, Andrés Biescas-Merino, Jacobo Yáñez, Carlos Isanta, Blanca Ferrández, Enrique Fuentemilla, Susana Pérez-Oliván, Noemí Güerri, José Manuel Larrosa, Vicente Polo, Luis Emilio Pablo
{"title":"一项为期四年的回顾性研究:XEN45 对青光眼患者的临床疗效。","authors":"María Pilar Bambó, Álvaro Tello, María José Vicente, Víctor Mallén, Andrés Biescas-Merino, Jacobo Yáñez, Carlos Isanta, Blanca Ferrández, Enrique Fuentemilla, Susana Pérez-Oliván, Noemí Güerri, José Manuel Larrosa, Vicente Polo, Luis Emilio Pablo","doi":"10.1159/000539504","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The main purpose of the current study was to evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma.</p><p><strong>Methods: </strong>Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values.</p><p><strong>Results: </strong>Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+phacoemulsification). The mean preoperative IOP was significantly higher in the XEN-alone (22.2 ± 5.9 mm Hg) than in the XEN+Phaco (19.8 ± 4.5 mm Hg) group (p = 0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5 ± 5.0 mm Hg to 15.8 ± 4.4 at year-4, p < 0.0001. The mean preoperative (95% confidence interval) IOP was significantly lowered from 22.2 (20.6-23.8) mm Hg and 19.8 (19.1-20.6) mm Hg to 15.6 (12.2-16.9) mm Hg and 15.9 (15.2-16.5) mm Hg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p < 0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6 ± 1.0 drugs to 1.3 ± 1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p = 0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure.</p><p><strong>Conclusion: </strong>XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduced the need of ocular hypotensive medication in the long-term.</p>","PeriodicalId":19662,"journal":{"name":"Ophthalmic Research","volume":" ","pages":"478-487"},"PeriodicalIF":2.0000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A 4-Year Retrospective Study: Clinical Outcomes of XEN45 in Patients with Glaucoma.\",\"authors\":\"María Pilar Bambó, Álvaro Tello, María José Vicente, Víctor Mallén, Andrés Biescas-Merino, Jacobo Yáñez, Carlos Isanta, Blanca Ferrández, Enrique Fuentemilla, Susana Pérez-Oliván, Noemí Güerri, José Manuel Larrosa, Vicente Polo, Luis Emilio Pablo\",\"doi\":\"10.1159/000539504\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The main purpose of the current study was to evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma.</p><p><strong>Methods: </strong>Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values.</p><p><strong>Results: </strong>Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+phacoemulsification). The mean preoperative IOP was significantly higher in the XEN-alone (22.2 ± 5.9 mm Hg) than in the XEN+Phaco (19.8 ± 4.5 mm Hg) group (p = 0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5 ± 5.0 mm Hg to 15.8 ± 4.4 at year-4, p < 0.0001. The mean preoperative (95% confidence interval) IOP was significantly lowered from 22.2 (20.6-23.8) mm Hg and 19.8 (19.1-20.6) mm Hg to 15.6 (12.2-16.9) mm Hg and 15.9 (15.2-16.5) mm Hg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p < 0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6 ± 1.0 drugs to 1.3 ± 1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p = 0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure.</p><p><strong>Conclusion: </strong>XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduced the need of ocular hypotensive medication in the long-term.</p>\",\"PeriodicalId\":19662,\"journal\":{\"name\":\"Ophthalmic Research\",\"volume\":\" \",\"pages\":\"478-487\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmic Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000539504\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/17 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ophthalmic Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000539504","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/17 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
A 4-Year Retrospective Study: Clinical Outcomes of XEN45 in Patients with Glaucoma.
Introduction: The main purpose of the current study was to evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma.
Methods: Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values.
Results: Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+phacoemulsification). The mean preoperative IOP was significantly higher in the XEN-alone (22.2 ± 5.9 mm Hg) than in the XEN+Phaco (19.8 ± 4.5 mm Hg) group (p = 0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5 ± 5.0 mm Hg to 15.8 ± 4.4 at year-4, p < 0.0001. The mean preoperative (95% confidence interval) IOP was significantly lowered from 22.2 (20.6-23.8) mm Hg and 19.8 (19.1-20.6) mm Hg to 15.6 (12.2-16.9) mm Hg and 15.9 (15.2-16.5) mm Hg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p < 0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6 ± 1.0 drugs to 1.3 ± 1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p = 0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure.
Conclusion: XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduced the need of ocular hypotensive medication in the long-term.
期刊介绍:
''Ophthalmic Research'' features original papers and reviews reporting on translational and clinical studies. Authors from throughout the world cover research topics on every field in connection with physical, physiologic, pharmacological, biochemical and molecular biological aspects of ophthalmology. This journal also aims to provide a record of international clinical research for both researchers and clinicians in ophthalmology. Finally, the transfer of information from fundamental research to clinical research and clinical practice is particularly welcome.