New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study
Bogomil Voykov, Emil Nasyrov, Jonas Neubauer, Caroline J Gassel Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, GermanyCorrespondence: Bogomil Voykov, Centre for Ophthalmology, University Hospital Tuebingen, Elfriede-Aulhorn-Str. 7, Tuebingen, 72076, Germany, Tel +49 7071 2988088...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-08-01
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| Series: | Clinical Ophthalmology |
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| Online Access: | https://www.dovepress.com/new-xen63-gel-stent-implantation-in-open-angle-glaucoma-a-two-year-fol-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1797752591257436160 |
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| author | Voykov B Nasyrov E Neubauer J Gassel CJ |
| author_facet | Voykov B Nasyrov E Neubauer J Gassel CJ |
| author_sort | Voykov B |
| collection | DOAJ |
| description | Bogomil Voykov, Emil Nasyrov, Jonas Neubauer, Caroline J Gassel Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, GermanyCorrespondence: Bogomil Voykov, Centre for Ophthalmology, University Hospital Tuebingen, Elfriede-Aulhorn-Str. 7, Tuebingen, 72076, Germany, Tel +49 7071 2988088, Fax +49 7071 295455, Email bogomil.voykov@med.uni-tuebingen.dePurpose: The XEN gel stent was developed to reduce the risks of filtration surgery by standardizing the outflow of aqueous humor into the subconjunctival space. Recently, a modified version of the XEN63 gel stent was introduced. The goal of this study was to assess its efficacy and safety.Methods: This is a prospective, nonrandomized, observational, consecutive case series study at a single tertiary centre. Patients with open-angle glaucoma with above target intraocular pressure (IOP) despite maximal tolerated medication were included. The primary outcome was a change of median IOP. Secondary outcomes included a change in the number of medications, complete success, needling and complication rates. Success was defined as a lowering of IOP > 20% from baseline and IOP ≤ 14 mmHg. Complete success indicated that the target IOP was reached without medications.Results: Six patients were included. The median IOP decreased from 35.5 mmHg (25.0– 40.0 mmHg) at baseline to 11.5 mmHg (4.0– 15.0 mmHg, p = 0.03), and median IOP-lowering medication was reduced from 4.0 (3.0– 4.0) at baseline to 0 (0– 1.0, p = 0.03) after two years. Five patients (83.0%) had a complete success after two years. Two patients (33.0%) required a needling procedure. Three patients (50.0%) required an intervention due to symptomatic hypotony within the first three weeks postoperatively. Hypotony resolved completely or was asymptomatic after three months.Conclusion: Our study demonstrated a statistically significant reduction in both IOP and number of IOP-lowering medications. Complications were well manageable and had no long-term sequelae.Keywords: open-angle glaucoma, filtering surgery, minimally invasive surgery, glaucoma gel stent |
| first_indexed | 2024-03-12T17:05:35Z |
| format | Article |
| id | doaj.art-f59da49c6fd64cdb89ef937fd67f6d5b |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-03-12T17:05:35Z |
| publishDate | 2023-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-f59da49c6fd64cdb89ef937fd67f6d5b2023-08-06T18:59:49ZengDove Medical PressClinical Ophthalmology1177-54832023-08-01Volume 172243224985692New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot StudyVoykov BNasyrov ENeubauer JGassel CJBogomil Voykov, Emil Nasyrov, Jonas Neubauer, Caroline J Gassel Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, GermanyCorrespondence: Bogomil Voykov, Centre for Ophthalmology, University Hospital Tuebingen, Elfriede-Aulhorn-Str. 7, Tuebingen, 72076, Germany, Tel +49 7071 2988088, Fax +49 7071 295455, Email bogomil.voykov@med.uni-tuebingen.dePurpose: The XEN gel stent was developed to reduce the risks of filtration surgery by standardizing the outflow of aqueous humor into the subconjunctival space. Recently, a modified version of the XEN63 gel stent was introduced. The goal of this study was to assess its efficacy and safety.Methods: This is a prospective, nonrandomized, observational, consecutive case series study at a single tertiary centre. Patients with open-angle glaucoma with above target intraocular pressure (IOP) despite maximal tolerated medication were included. The primary outcome was a change of median IOP. Secondary outcomes included a change in the number of medications, complete success, needling and complication rates. Success was defined as a lowering of IOP > 20% from baseline and IOP ≤ 14 mmHg. Complete success indicated that the target IOP was reached without medications.Results: Six patients were included. The median IOP decreased from 35.5 mmHg (25.0– 40.0 mmHg) at baseline to 11.5 mmHg (4.0– 15.0 mmHg, p = 0.03), and median IOP-lowering medication was reduced from 4.0 (3.0– 4.0) at baseline to 0 (0– 1.0, p = 0.03) after two years. Five patients (83.0%) had a complete success after two years. Two patients (33.0%) required a needling procedure. Three patients (50.0%) required an intervention due to symptomatic hypotony within the first three weeks postoperatively. Hypotony resolved completely or was asymptomatic after three months.Conclusion: Our study demonstrated a statistically significant reduction in both IOP and number of IOP-lowering medications. Complications were well manageable and had no long-term sequelae.Keywords: open-angle glaucoma, filtering surgery, minimally invasive surgery, glaucoma gel stenthttps://www.dovepress.com/new-xen63-gel-stent-implantation-in-open-angle-glaucoma-a-two-year-fol-peer-reviewed-fulltext-article-OPTHopen-angle glaucomafiltering surgeryminimally invasive surgeryglaucoma gel stent |
| spellingShingle | Voykov B Nasyrov E Neubauer J Gassel CJ New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study Clinical Ophthalmology open-angle glaucoma filtering surgery minimally invasive surgery glaucoma gel stent |
| title | New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study |
| title_full | New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study |
| title_fullStr | New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study |
| title_full_unstemmed | New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study |
| title_short | New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study |
| title_sort | new xen63 gel stent implantation in open angle glaucoma a two year follow up pilot study |
| topic | open-angle glaucoma filtering surgery minimally invasive surgery glaucoma gel stent |
| url | https://www.dovepress.com/new-xen63-gel-stent-implantation-in-open-angle-glaucoma-a-two-year-fol-peer-reviewed-fulltext-article-OPTH |
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