Three-year effectiveness and safety of the XEN gel stent as a solo procedure or in combination with phacoemulsification in open-angle glaucoma: a multicentre study
| Autor: | Andrew Shirlaw, Leon Au, Simon Ruben, Vanessa I. Vera, Jorge Vila-Arteaga, Ingeborg Stalmans, Herbert A. Reitsamer, Mini Balaram, Miguel A. Teus, Markus Lenzhofer, Zhanying Bai |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Intraocular pressure medicine.medical_specialty Time Factors Open angle glaucoma genetic structures implant medicine.medical_treatment Glaucoma Prosthesis Design 03 medical and health sciences 0302 clinical medicine medicine Humans Adverse effect Glaucoma Drainage Implants Intraocular Pressure Aged Retrospective Studies Science & Technology Phacoemulsification business.industry MIGS Stent General Medicine medicine.disease eye diseases Surgery Safety profile Ophthalmology glaucoma Treatment Outcome gel stent 030221 ophthalmology & optometry Female Stents Implant sense organs IMPLANTATION business Life Sciences & Biomedicine XEN 030217 neurology & neurosurgery Glaucoma Open-Angle intraocular pressure Follow-Up Studies |
| Zdroj: | Acta ophthalmologica. 100(1) |
| ISSN: | 1755-3768 |
| Popis: | PURPOSE: To assess the 3-year effectiveness and safety of the XEN gel stent implanted ab interno in open-angle glaucoma (OAG). METHODS: This study was a multicentre, retrospective chart review of consecutive patients with OAG who underwent ab-interno gel stent placement alone or combined with phacoemulsification between 1 January 2014 and 1 October 2015. Outcome measures included mean changes in intraocular pressure (IOP) and IOP-lowering medication count from medicated baseline at 1, 2, 3 (primary outcome) and 4 years (if available) postimplantation. Intraoperative complications, adverse events of special interest (AESIs) and secondary surgical interventions (SSIs) were recorded. RESULTS: The safety and effectiveness populations included 212 eyes (primary and secondary) and 174 eyes (primary), respectively. Mean IOP and medication decreased from 20.7 mmHg and 2.5 at baseline (n = 163 primary/first implanted eyes) to 13.9 mmHg and 1.1 medications (n = 76) at 3 years postimplantation, respectively. Mean changes from baseline in IOP (-5.6, -6.2 and -6.6 mmHg) and IOP-lowering medication count (-1.8, -1.6 and -1.4) were statistically significant at 1, 2 and 3 years postimplantation, respectively. Results appeared comparable when implantation was performed with (n = 76) or without (n = 98) phacoemulsification. In primary eyes with 4-year IOP and medication count data (n = 27), mean IOP was 14.0 mmHg on 1.3 medications at 4 years postimplantation. Fifteen (7.1%) eyes had intraoperative complications, 31 (14.6%) experienced 46 postoperative AESIs, and 26 (12.3%) required SSI. CONCLUSION: The gel stent effectively lowered IOP and IOP-lowering medication count over 3 years, with a predictable and acceptable safety profile, when implanted via the traditional ab-interno technique. ispartof: ACTA OPHTHALMOLOGICA vol:100 issue:1 pages:E233-E245 ispartof: location:England status: published |
| Databáze: | OpenAIRE |
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