Bio-Interventional Uveoscleral Outflow Enhancement for Intraocular Pressure Reduction in Open-Angle Glaucoma: One-Year Results of a Multicenter Prospective Real-world Evidence Study

Bio-Interventional Uveoscleral Outflow Enhancement for Intraocular Pressure Reduction in Open-Angle Glaucoma: One-Year Results of a Multicenter Prospective Real-world Evidence Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Bio-Interventional Uveoscleral Outflow Enhancement for Intraocular Pressure Reduction in Open-Angle Glaucoma: One-Year Results of a Multicenter Prospective Real-world Evidence Study Tsontcho Ianchulev, George Reiss, Brian Francis, Quang Nguyen, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7216948/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Open-angle glaucoma (OAG) is a chronic optic neuropathy and major cause of blindness. Current treatments lower intraocular pressure (IOP) by enhancing aqueous outflow via the trabecular or uveoscleral pathways. This study reports on the safety and efficacy of a novel bio-interventional procedure for the surgical enhancement of uveoscleral outflow in OAG patients. Methods: This is a prospective analysis of an interventional cohort of a multicenter, real-world safety and effectiveness study of stand-alone uveoscleral outflow enhancement. Patients with OAG and intraocular pressure inadequately controlled on medical therapy underwent ab-interno cyclodialysis intervention with scleral bio-tissue reinforcement and were prospectively followed through 12 months postoperatively. Key efficacy and safety outcomes were the change in mean medicated IOP, the mean change in number of IOP lowering medications from baseline, and the incidence of ocular adverse events. Results: This primary analysis includes 41 cases who underwent successful stand-alone uveoscleral outflow intervention and completed 12-month follow-up. Among them, 37% had failed prior MIGS and SLT procedures. Additionally, 66% had failed IOP control with medical therapy and were surgical candidates for conventional glaucoma filtration or tube surgery. The baseline medicated IOP for all 41 eyes was 21.6 ± 5.0 mmHg, with an average preoperative medication burden of 2.8 ± 1.3. At 12 months, mean medicated IOP decreased by 31% to 14.7 ± 5.4 mmHg (p 20% IOP reduction from baseline on the same of fewer medications. During the 12-month follow-up period, only 3 eyes required additional incisional glaucoma surgery. The procedure was well tolerated, with no reported cases of bio-tissue migration, significant postoperative inflammation, change in visual acuity or clinically-significant hyphema. Conclusion: At the 12-month mark, ab-interno cyclodialysis with allograft reinforcement demonstrated a favorable safety profile and sustained IOP reduction as a standalone treatment. This conjunctiva-sparing, minimally invasive approach to enhancing uveoscleral outflow presents a promising surgical option—especially for patients in whom prior trabecular MIGS have failed, potentially reducing the need for more invasive interventions. Health sciences/Diseases/Eye diseases/Optic nerve diseases Health sciences/Medical research/Outcomes research Figures Figure 1 Figure 2 Figure 3 Full Text Additional Declarations There is conflict of interest Supplementary Files Table1.docx Table 1 Table2.docx Table 2 Table3.docx Table 3 Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7216948","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":491868848,"identity":"f8d9cad5-9874-4ee8-af51-a0461e4fe07c","order_by":0,"name":"Tsontcho 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Real-world Evidence Study","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-7216948/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7216948/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOpen-angle glaucoma (OAG) is a chronic optic neuropathy and major cause of blindness. Current treatments lower intraocular pressure (IOP) by enhancing aqueous outflow via the trabecular or uveoscleral pathways. This study reports on the safety and efficacy of a novel bio-interventional procedure for the surgical enhancement of uveoscleral outflow in OAG patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a prospective analysis of an interventional cohort of a multicenter, real-world safety and effectiveness study of stand-alone uveoscleral outflow enhancement. Patients with OAG and intraocular pressure inadequately controlled on medical therapy underwent ab-interno cyclodialysis intervention with scleral bio-tissue reinforcement and were prospectively followed through 12 months postoperatively. Key efficacy and safety outcomes were the change in mean medicated IOP, the mean change in number of IOP lowering medications from baseline, and the incidence of ocular adverse events.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis primary analysis includes 41 cases who underwent successful stand-alone uveoscleral outflow intervention and completed 12-month follow-up. Among them, 37% had failed prior MIGS and SLT procedures. Additionally, 66% had failed IOP control with medical therapy and were surgical candidates for conventional glaucoma filtration or tube surgery. The baseline medicated IOP for all 41 eyes was 21.6 ± 5.0 mmHg, with an average preoperative medication burden of 2.8 ± 1.3. At 12 months, mean medicated IOP decreased by 31% to 14.7 ± 5.4 mmHg (p \u0026lt; 0.01), and the mean number of medications was reduced to 1.9 ± 1.0. Notably, 71% of treated eyes achieved a \u0026gt;20% IOP reduction from baseline on the same of fewer medications. During the 12-month follow-up period, only 3 eyes required additional incisional glaucoma surgery. The procedure was well tolerated, with no reported cases of bio-tissue migration, significant postoperative inflammation, change in visual acuity or clinically-significant hyphema.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt the 12-month mark, ab-interno cyclodialysis with allograft reinforcement demonstrated a favorable safety profile and sustained IOP reduction as a standalone treatment. This conjunctiva-sparing, minimally invasive approach to enhancing uveoscleral outflow presents a promising surgical option—especially for patients in whom prior trabecular MIGS have failed, potentially reducing the need for more invasive interventions.\u003c/p\u003e","manuscriptTitle":"Bio-Interventional Uveoscleral Outflow Enhancement for Intraocular Pressure Reduction in Open-Angle Glaucoma: One-Year Results of a Multicenter Prospective Real-world Evidence Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-29 10:33:41","doi":"10.21203/rs.3.rs-7216948/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"27505aaf-424d-4eb8-9630-85daa8286e3d","owner":[],"postedDate":"July 29th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":52218123,"name":"Health sciences/Diseases/Eye diseases/Optic nerve diseases"},{"id":52218124,"name":"Health sciences/Medical research/Outcomes research"}],"tags":[],"updatedAt":"2025-10-27T15:00:27+00:00","versionOfRecord":[],"versionCreatedAt":"2025-07-29 10:33:41","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7216948","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7216948","identity":"rs-7216948","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}