Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study

AIM: To assess the effectiveness of the XEN 45 gel stent, either alone or combined with cataract surgery, in advanced stage open angle glaucoma (OAG) patients. METHODS: Retrospective and single-center study conducted on consecutive OAG patients who underwent a XEN 45 gel stent implantation surgery,...

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Main Authors: Teresa Laborda-Guirao, Juan M Cubero-Parra, Antonio Hidalgo-Torres
Format: Article
Language:English
Published: Press of International Journal of Ophthalmology (IJO PRESS) 2020-08-01
Series:International Journal of Ophthalmology
Subjects:
Online Access:http://ies.ijo.cn/en_publish/2020/8/20200811.pdf
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author Teresa Laborda-Guirao
Juan M Cubero-Parra
Antonio Hidalgo-Torres
author_facet Teresa Laborda-Guirao
Juan M Cubero-Parra
Antonio Hidalgo-Torres
author_sort Teresa Laborda-Guirao
collection DOAJ
description AIM: To assess the effectiveness of the XEN 45 gel stent, either alone or combined with cataract surgery, in advanced stage open angle glaucoma (OAG) patients. METHODS: Retrospective and single-center study conducted on consecutive OAG patients who underwent a XEN 45 gel stent implantation surgery, between July 2017 and September 2018. The primary efficacy end-point was the mean intraocular pressure (IOP) reduction at the end of the follow-up period. Success was defined as an IOP reduction of at least 20% and an IOP value ≤18 mm Hg without (complete) or with (qualified) hypotensive medication. RESULTS: Seventy-four patients (80 eyes) were included in the study. In the overall study sample, XEN implant significantly reduced IOP from 21.0 (19.8 to 22.1) mm Hg at baseline to 9.3 (8.2 to 10.4), 10.7 (9.6 to 11.9), 13.4 (12.2 to 14.7), 14.5 (13.6 to 15.4), 14.7 (13.8 to 15.6), and 14.7 (13.9 to 15.4) mm Hg at 1d, 1wk, 1, 3, 6, and 12mo of follow-up, respectively (P<0.0001 each). In the overall study population, at the end of the study the mean IOP reduction was 27.4% (23.3% to 31.5%). Adjusted IOP reduction was similar in XEN and XEN+phacoemulsification groups [30.0 (23.4 to 36.4) mm Hg vs 24.8 (18.4 to 31.2) mm Hg, respectively, P=0.2939]. At the last follow-up visit, 52 (65.0%) eyes were considered success, 29 (36.3%) eyes as complete success and 23 (28.7%) as qualified success. Mean number of hypotensive medications was significantly reduced from 2.8 (2.7 to 3.0) at baseline to 1.1 (0.8 to 1.3), P<0.0001. Kaplan-Meier survival analysis did not find any difference in the success rate between XEN and XEN+PHACO, mean hazard ratio 0.56, 95%CI 0.26 to 1.23; P=0.1469. Needling was performed in 7 (8.8%) eyes at months 1 (n=3); 3 (n=2); 4 (n=1) and 11 (n=1). Eleven (13.8%) eyes presented adverse events. CONCLUSION: XEN implant, either alone or in combination with phacoemulsification, significantly reduced the IOP and the number of hypotensive medications in patients with OAG in advanced stage.
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spelling doaj.art-56465045d9154171a19a3d08b1632e122022-12-21T23:58:19ZengPress of International Journal of Ophthalmology (IJO PRESS)International Journal of Ophthalmology2222-39592227-48982020-08-011381250125610.18240/ijo.2020.08.11Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective studyTeresa Laborda-Guirao0Juan M Cubero-Parra1Antonio Hidalgo-Torres2Department of Glaucoma, Hospital La Arruzafa, Córdoba 14012, SpainDepartment of Glaucoma, Hospital La Arruzafa, Córdoba 14012, SpainDepartment of Glaucoma, Hospital La Arruzafa, Córdoba 14012, SpainAIM: To assess the effectiveness of the XEN 45 gel stent, either alone or combined with cataract surgery, in advanced stage open angle glaucoma (OAG) patients. METHODS: Retrospective and single-center study conducted on consecutive OAG patients who underwent a XEN 45 gel stent implantation surgery, between July 2017 and September 2018. The primary efficacy end-point was the mean intraocular pressure (IOP) reduction at the end of the follow-up period. Success was defined as an IOP reduction of at least 20% and an IOP value ≤18 mm Hg without (complete) or with (qualified) hypotensive medication. RESULTS: Seventy-four patients (80 eyes) were included in the study. In the overall study sample, XEN implant significantly reduced IOP from 21.0 (19.8 to 22.1) mm Hg at baseline to 9.3 (8.2 to 10.4), 10.7 (9.6 to 11.9), 13.4 (12.2 to 14.7), 14.5 (13.6 to 15.4), 14.7 (13.8 to 15.6), and 14.7 (13.9 to 15.4) mm Hg at 1d, 1wk, 1, 3, 6, and 12mo of follow-up, respectively (P<0.0001 each). In the overall study population, at the end of the study the mean IOP reduction was 27.4% (23.3% to 31.5%). Adjusted IOP reduction was similar in XEN and XEN+phacoemulsification groups [30.0 (23.4 to 36.4) mm Hg vs 24.8 (18.4 to 31.2) mm Hg, respectively, P=0.2939]. At the last follow-up visit, 52 (65.0%) eyes were considered success, 29 (36.3%) eyes as complete success and 23 (28.7%) as qualified success. Mean number of hypotensive medications was significantly reduced from 2.8 (2.7 to 3.0) at baseline to 1.1 (0.8 to 1.3), P<0.0001. Kaplan-Meier survival analysis did not find any difference in the success rate between XEN and XEN+PHACO, mean hazard ratio 0.56, 95%CI 0.26 to 1.23; P=0.1469. Needling was performed in 7 (8.8%) eyes at months 1 (n=3); 3 (n=2); 4 (n=1) and 11 (n=1). Eleven (13.8%) eyes presented adverse events. CONCLUSION: XEN implant, either alone or in combination with phacoemulsification, significantly reduced the IOP and the number of hypotensive medications in patients with OAG in advanced stage.http://ies.ijo.cn/en_publish/2020/8/20200811.pdfopen angle glaucomaadvanced stagexen implantintraocular pressureminimally-invasive glaucoma surgery
spellingShingle Teresa Laborda-Guirao
Juan M Cubero-Parra
Antonio Hidalgo-Torres
Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study
International Journal of Ophthalmology
open angle glaucoma
advanced stage
xen implant
intraocular pressure
minimally-invasive glaucoma surgery
title Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study
title_full Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study
title_fullStr Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study
title_full_unstemmed Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study
title_short Efficacy and safety of XEN 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients: 1-year retrospective study
title_sort efficacy and safety of xen 45 gel stent alone or in combination with phacoemulsification in advanced open angle glaucoma patients 1 year retrospective study
topic open angle glaucoma
advanced stage
xen implant
intraocular pressure
minimally-invasive glaucoma surgery
url http://ies.ijo.cn/en_publish/2020/8/20200811.pdf
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AT antoniohidalgotorres efficacyandsafetyofxen45gelstentaloneorincombinationwithphacoemulsificationinadvancedopenangleglaucomapatients1yearretrospectivestudy