{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T13:01:39Z","timestamp":1785416499462,"version":"3.56.0"},"reference-count":29,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T00:00:00Z","timestamp":1777939200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AbbVie"},{"id":[{"id":"https:\/\/ror.org\/00g7fhp37","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Purpose: To evaluate the 3-year effectiveness and safety of the XEN63 Gel Stent, both as a standalone procedure and combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Methods: This prospective, multicenter, non-randomized study included 85 eyes (85 patients) with medically-uncontrolled POAG. Subjects underwent either XEN63-standalone implantation (n = 46) or combined XEN63 + Phacoemulsification (n = 39). The primary endpoint was the cumulative probability of complete success (IOP \u2265 6 and \u226518 mmHg and reduction in IOP \u2265 20% from baseline without ocular-hypotensive medications) at 36 months. Results: At 36-months, the overall surgical success rate was 67.1% (95% CI: 50.8\u201386.9%), with significant differences between the standalone (78.3%) and combined groups (53.9%; p = 0.0173). Complete success was achieved in 45.9% of the total cohort. Preoperative mean IOP decreased significantly from 21.3 \u00b1 4.7 mmHg to 14.3 \u00b1 4.3 mmHg at the last-follow-up visit (LFUV) (p &lt; 0.0001). Correspondingly, the mean number of medications was significantly reduced from 2.3 \u00b1 0.8 to 0.7 \u00b1 1.0 (p &lt; 0.0001). Multivariable analysis showed that surgical strategy did not significantly influence IOP reduction. Numerical hypotony (IOP &lt; 6 mmHg) occurred in 23.5% of eyes at Day 1 but resolved in 95% of cases by Month 1. One case of hypotonic maculopathy required device explantation. Serious late-onset events included one endophthalmitis (Month 30) and one retinal detachment (Month 26). Secondary needling was required in 8.2% of eyes. Conclusions: The XEN63 Gel Stent provided sustained IOP reduction and a significantly decreased medication burden over 36 months. Outcomes remained consistent regardless of whether the stent was implanted as a standalone procedure or combined with cataract surgery.<\/jats:p>","DOI":"10.3390\/jcm15093528","type":"journal-article","created":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T13:23:37Z","timestamp":1777987417000},"page":"3528","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Three-Year Outcomes and Safety of the XEN63 Gel Stent: A Multicenter Prospective Study in Primary Open-Angle Glaucoma"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9441-0542","authenticated-orcid":false,"given":"Jos\u00e9 Mar\u00eda","family":"Mart\u00ednez-de-la-Casa","sequence":"first","affiliation":[{"name":"Ophthalmology Unit, Department of Ophthalmology and ORL, Faculty of Medicine, Hospital Clinico San-Carlos, Universidad Complutense de Madrid, Instituto de Investigaci\u00f3n Sanitaria del Hospital Cl\u00ednico San-Carlos (IdISSC), Calle del Prof Mart\u00edn Lagos, s\/n, 28040 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7408-6669","authenticated-orcid":false,"given":"Mar\u00eda Teresa","family":"Marcos-Parra","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Hospital General Universitario de Alicante, 03010 Alicante, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5171-165X","authenticated-orcid":false,"given":"Elena","family":"Mill\u00e1-Gri\u00f1\u00f3","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Hospital Clinic, 08036 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Laborda","sequence":"additional","affiliation":[{"name":"Glaucoma Department, Hospital La Arruzafa, 14012 C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4675-9373","authenticated-orcid":false,"given":"Rafael","family":"Gim\u00e9nez","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Reina Sofia University Hospital, 14004 C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Manuel","family":"Larrosa","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Miguel Servet University Hospital, 50009 Zaragoza, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aritz","family":"Urcola","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Araba University Hospital, 01004 Araba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3835-9882","authenticated-orcid":false,"given":"Miguel \u00c1ngel","family":"Teus","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Alcala University Hospital, 28805 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2585-8420","authenticated-orcid":false,"given":"Susana","family":"Perucho-Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Ophthalmology Department, Hospital Universitario de Fuenlabrada, 28942 Fuenlabrada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,5,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2081","DOI":"10.1016\/j.ophtha.2014.05.013","article-title":"Global prevalence of glaucoma and projections of glaucoma burden through 2040: A systematic review and meta-analysis","volume":"121","author":"Tham","year":"2014","journal-title":"Ophthalmology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1788","DOI":"10.1016\/S0140-6736(23)01289-8","article-title":"Glaucoma: Now and beyond","volume":"402","author":"Jayaram","year":"2023","journal-title":"Lancet"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1136\/bjophthalmol-2025-egsguidelines","article-title":"European Glaucoma Society\u2014Terminology and guidelines for glaucoma, 6th Edition","volume":"109","author":"Pazos","year":"2025","journal-title":"Br. 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