Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

Inder Paul Singh,1 Steven Sarkisian Jnr,2 Dana Hornbeak,3 L Jay Katz,3,4 Thomas Samuelson5 for the iStent inject Study Group1The Eyes Centers of Racine & Kenosha, Racine, WI, USA; 2Oklahoma Eye Surgeons, Oklahoma City, OK, USA; 3Glaukos Corporation, San Clemente, CA, USA; 4Wills Eye Hospital, Ph...

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Autores principales:	Singh IP, Sarkisian Jnr S, Hornbeak D, Katz LJ, Samuelson T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	microinvasive glaucoma surgery/migs glaucoma istent inject trabecular micro-bypass iop stratification severity Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/adcc046093d84056af60073d8935af5f
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spelling	oai:doaj.org-article:adcc046093d84056af60073d8935af5f2021-12-02T19:01:46ZTreatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract1177-5483https://doaj.org/article/adcc046093d84056af60073d8935af5f2021-08-01T00:00:00Zhttps://www.dovepress.com/treatment-success-across-different-levels-of-preoperative-disease-burd-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Inder Paul Singh,1 Steven Sarkisian Jnr,2 Dana Hornbeak,3 L Jay Katz,3,4 Thomas Samuelson5 for the iStent inject Study Group1The Eyes Centers of Racine & Kenosha, Racine, WI, USA; 2Oklahoma Eye Surgeons, Oklahoma City, OK, USA; 3Glaukos Corporation, San Clemente, CA, USA; 4Wills Eye Hospital, Philadelphia, PA, USA; 5Minnesota Eye Consultants, Minneapolis, MN, USACorrespondence: Inder Paul SinghThe Eye Center of Racine, 3805 B Spring Street, Suite 140, Racine, WI, 53405, USA Tel +1 262 637 0500Fax +1 262 637 7650Email inderspeak@gmail.comPurpose: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject® with cataract surgery (INJ) vs cataract surgery alone (CS).Materials and Methods: Prospective, 3:1 randomized, single-masked, concurrently-controlled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP < 25mmHg, Mid-DIOP ≥ 25 to < 30 mmHg, High-DIOP ≥ 30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥ 3 medications).Results: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥ 20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone.Conclusion: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device’s potential utility in more medically challenging cases.Keywords: microinvasive glaucoma surgery/MIGS, glaucoma, iStent inject, trabecular micro-bypass, IOP, stratification, severitySingh IPSarkisian Jnr SHornbeak DKatz LJSamuelson TDove Medical Pressarticlemicroinvasive glaucoma surgery/migsglaucomaistent injecttrabecular micro-bypassiopstratificationseverityOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3231-3240 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	microinvasive glaucoma surgery/migs glaucoma istent inject trabecular micro-bypass iop stratification severity Ophthalmology RE1-994
spellingShingle	microinvasive glaucoma surgery/migs glaucoma istent inject trabecular micro-bypass iop stratification severity Ophthalmology RE1-994 Singh IP Sarkisian Jnr S Hornbeak D Katz LJ Samuelson T Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract
description	Inder Paul Singh,1 Steven Sarkisian Jnr,2 Dana Hornbeak,3 L Jay Katz,3,4 Thomas Samuelson5 for the iStent inject Study Group1The Eyes Centers of Racine & Kenosha, Racine, WI, USA; 2Oklahoma Eye Surgeons, Oklahoma City, OK, USA; 3Glaukos Corporation, San Clemente, CA, USA; 4Wills Eye Hospital, Philadelphia, PA, USA; 5Minnesota Eye Consultants, Minneapolis, MN, USACorrespondence: Inder Paul SinghThe Eye Center of Racine, 3805 B Spring Street, Suite 140, Racine, WI, 53405, USA Tel +1 262 637 0500Fax +1 262 637 7650Email inderspeak@gmail.comPurpose: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject® with cataract surgery (INJ) vs cataract surgery alone (CS).Materials and Methods: Prospective, 3:1 randomized, single-masked, concurrently-controlled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP < 25mmHg, Mid-DIOP ≥ 25 to < 30 mmHg, High-DIOP ≥ 30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥ 3 medications).Results: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥ 20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone.Conclusion: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device’s potential utility in more medically challenging cases.Keywords: microinvasive glaucoma surgery/MIGS, glaucoma, iStent inject, trabecular micro-bypass, IOP, stratification, severity
format	article
author	Singh IP Sarkisian Jnr S Hornbeak D Katz LJ Samuelson T
author_facet	Singh IP Sarkisian Jnr S Hornbeak D Katz LJ Samuelson T
author_sort	Singh IP
title	Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract
title_short	Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract
title_full	Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract
title_fullStr	Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract
title_full_unstemmed	Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract
title_sort	treatment success across different levels of preoperative disease burden: stratified two-year outcomes from the pivotal trial of istent inject® trabecular micro-bypass in primary open-angle glaucoma and cataract
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/adcc046093d84056af60073d8935af5f
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_version_	1718377288099168256

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject&reg; Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

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Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract