{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T17:54:17Z","timestamp":1782496457282,"version":"3.54.5"},"reference-count":17,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T00:00:00Z","timestamp":1782432000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Iantrek, Inc."}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:p>This prospective, multicenter, real-world evidence study evaluates the 12-month safety and effectiveness of standalone cyclodialysis with AlloFlo\u2122 cleft reinforcement for intraocular pressure (IOP) reduction in open-angle glaucoma (OAG). AlloFlo represents the world\u2019s first acellular, allogenic scleral tissue implant, and data from this CREST Study cohort (NCT05506423) contribute critical 12 month safety and effectiveness knowledge to the field of extracellular matrix biomaterials research, in addition to describing a novel procedure for surgical management of OAG. Eyes with investigator-confirmed inadequately controlled OAG were treated with standalone cyclodialysis using a microsurgical cannula (CycloPen\u2122), followed by uveoscleral cleft reinforcement with AlloFlo. Eyes were followed prospectively for 12 months. Key outcomes included changes in medicated IOP, number of glaucoma medications, adverse events, and progression to subsequent glaucoma procedures. Forty-one eyes of 38 patients were included. Most eyes (66%) were considered treatment-refractory, defined as having any of: failed\u2009\u2265\u20091 incisional surgery or cilioablative procedure; condition in which incisional surgery would be more likely to fail than in eyes with uncomplicated OAG. At 12 months, mean IOP decreased 31% to 14.7\u2009\u00b1\u20096.9 mmHg (within the normal IOP range of 10\u201320 mmHg, p\u2009&lt;\u20090.001); mean number of glaucoma medications decreased 32% to 1.9\u2009\u00b1\u20091.6 (p\u2009&lt;\u20090.001). Seventy-one percent of eyes achieved\u2009\u2265\u200920% IOP reduction (a clinically meaningful benchmark set by the FDA). More than half of eyes (53%) achieved\u2009\u2265\u200920% IOP reduction without increasing medication. Three eyes (7.2%) progressed to incisional glaucoma surgery. Postoperative IOP elevations\u2009\u2265\u200910 mmHg occurred in 17% of eyes, most of which resolved within 30 days of the procedure. No persistent inflammation, implant rejection, clinically significant hyphema, or scaffold migration occurred. These findings suggest that uveoscleral outflow enhancement with AlloFlo provides a safe, conjunctiva-sparing option for IOP reduction in OAG, including eyes with prior surgical interventions.<\/jats:p>","DOI":"10.1371\/journal.pone.0351552","type":"journal-article","created":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T17:34:43Z","timestamp":1782495283000},"page":"e0351552","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Standalone bio-interventional uveoscleral outflow enhancement for intraocular pressure reduction in open-angle glaucoma: One-year results from a prospective multicenter real-world evidence study (NCT05506423)"],"prefix":"10.1371","volume":"21","author":[{"given":"George","family":"Reiss","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Francis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quang","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reena","family":"Garg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsontcho","family":"Ianchulev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Sieminski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,6,26]]},"reference":[{"issue":"11","key":"pone.0351552.ref001","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","volume":"121","author":"Y-C Tham","year":"2014","journal-title":"Ophthalmology"},{"issue":"18","key":"pone.0351552.ref002","doi-asserted-by":"crossref","first-page":"1901","DOI":"10.1001\/jama.2014.3192","article-title":"The pathophysiology and treatment of glaucoma: a review","volume":"311","author":"RN Weinreb","year":"2014","journal-title":"JAMA"},{"issue":"5","key":"pone.0351552.ref003","doi-asserted-by":"crossref","DOI":"10.1097\/00061198-200010000-00001","article-title":"Uveoscleral outflow: the other outflow pathway","volume":"9","author":"RN Weinreb","year":"2000","journal-title":"J Glaucoma"},{"issue":"4","key":"pone.0351552.ref004","first-page":"340","article-title":"Cyclodialysis and cycloanemization in glaucoma","volume":"197","author":"A Vogt","year":"1990","journal-title":"Klin Monbl Augenheilkd"},{"issue":"2","key":"pone.0351552.ref005","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1136\/bjo-2022-322536","article-title":"Biotissue stent for supraciliary outflow in open-angle glaucoma patients: surgical procedure and first clinical results of an aqueous drainage biostent","volume":"108","author":"T Ianchulev","year":"2024","journal-title":"Br J Ophthalmol"},{"key":"pone.0351552.ref006","first-page":"3605","article-title":"Allograft-reinforced bio-interventional uveoscleral surgery for glaucoma: 12-month outcomes of a prospective study","volume":"18","author":"T Ianchulev","year":"2024","journal-title":"Clin Ophthalmol"},{"issue":"2","key":"pone.0351552.ref007","first-page":"217","article-title":"Standalone uveoscleral intervention using bio-scaffolded cyclodialysis: a prospective case series","volume":"108","author":"J Chang","year":"2024","journal-title":"Br J Ophthalmol"},{"issue":"4","key":"pone.0351552.ref008","article-title":"Bio-interventional enhancement of uveoscleral outflow with allogeneic scaffolding: early efficacy and safety","volume":"5","author":"G Reiss","year":"2025","journal-title":"Ophthalmol Sci"},{"key":"pone.0351552.ref009","unstructured":"FDA. Premarket studies of implantable minimally invasive glaucoma surgical (MIGS) devices: guidance for industry and Food and Drug Administration staff. 2015. https:\/\/www.fda.gov\/media\/90950\/download"},{"issue":"1","key":"pone.0351552.ref010","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.ophtha.2019.04.034","article-title":"A prospective randomized trial comparing hydrus and istent microinvasive glaucoma surgery implants for standalone treatment of open-angle glaucoma: the COMPARE study","volume":"127","author":"IIK Ahmed","year":"2020","journal-title":"Ophthalmology"},{"issue":"1","key":"pone.0351552.ref011","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1097\/IJG.0000000000002141","article-title":"Effectiveness and safety of iStent infinite trabecular micro-bypass for uncontrolled glaucoma","volume":"32","author":"SR Sarkisian Jr","year":"2023","journal-title":"J Glaucoma"},{"issue":"24","key":"pone.0351552.ref012","doi-asserted-by":"crossref","first-page":"7703","DOI":"10.3390\/jcm13247703","article-title":"Meta-analysis of MINIject vs. two iStents as standalone treatment for glaucoma with 24 months of follow-up","volume":"13","author":"JCK Tan","year":"2024","journal-title":"J Clin Med"},{"key":"pone.0351552.ref013","unstructured":"Glaucos Corporation. iStent infinite 510(k) summary K220032. 2022. https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf22\/K220032.pdf"},{"issue":"2","key":"pone.0351552.ref014","first-page":"163","article-title":"Corticosteroid-induced ocular hypertension and glaucoma: a brief review and update of the literature","volume":"17","author":"3rd Jones R","year":"2006","journal-title":"Curr Opin Ophthalmol"},{"issue":"2","key":"pone.0351552.ref015","first-page":"160","article-title":"Comparative analysis of IOP spikes after minimally invasive glaucoma surgeries","volume":"32","author":"E Sieck","year":"2021","journal-title":"Curr Opin Ophthalmol"},{"key":"pone.0351552.ref016","first-page":"927","article-title":"Outcomes of the XEN45 gel stent: a systematic review and meta-analysis","volume":"262","author":"H Reitsamer","year":"2024","journal-title":"Graefes Arch Clin Exp Ophthalmol"},{"issue":"5","key":"pone.0351552.ref017","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1136\/bjophthalmol-2015-307131","article-title":"Review and meta-analysis of ab-interno trabeculectomy outcomes","volume":"100","author":"K Kaplowitz","year":"2016","journal-title":"Br J Ophthalmol"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0351552","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T17:34:47Z","timestamp":1782495287000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0351552"}},"subtitle":[],"editor":[{"given":"Natasha","family":"Gautam","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,6,26]]},"references-count":17,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2026,6,26]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0351552","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,26]]}}}