Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study

Mark J Gallardo,1 Steven R Sarkisian Jr,2 Steven D Vold,3 Inder Paul Singh,4 Brian E Flowers,5 Anita Campbell,6 Kavita Dhamdhere,7 Thomas W Samuelson8 On behalf of the GEMINI study group1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK, USA; 3Vold Vision, F...

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Autores principales:	Gallardo MJ, Sarkisian SR Jr, Vold SD, Singh IP, Flowers BE, Campbell A, Dhamdhere K, Samuelson TW
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	viscodilation migs open-angle glaucoma glaucoma surgery canaloplasty trabeculotomy omni Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/885e80e612134cb28df3267d472d6a23
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spelling	oai:doaj.org-article:885e80e612134cb28df3267d472d6a232021-12-02T14:14:46ZCanaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study1177-5483https://doaj.org/article/885e80e612134cb28df3267d472d6a232021-02-01T00:00:00Zhttps://www.dovepress.com/canaloplasty-and-trabeculotomy-combined-with-phacoemulsification-in-op-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Mark J Gallardo,1 Steven R Sarkisian Jr,2 Steven D Vold,3 Inder Paul Singh,4 Brian E Flowers,5 Anita Campbell,6 Kavita Dhamdhere,7 Thomas W Samuelson8 On behalf of the GEMINI study group1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK, USA; 3Vold Vision, Fayetteville, AR, USA; 4Eye Centers of Racine & Kenosha, Racine, WI, USA; 5Ophthalmology Associates, Fort Worth, TX, USA; 6Grene Vision Group, Wichita, KS, USA; 7Sight Sciences, Menlo Park, CA, USA; 8Minnesota Eye Consultants, Minneapolis, MN, USACorrespondence: Kavita Dhamdhere Email kdhamdhere@sightsciences.comPurpose: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG).Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin).Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤ 33 mmHg on 1 to 4 hypotensive medications.Methods: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline.Results: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥ 6 and ≤ 18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥ 10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI.Conclusion: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.Keywords: viscodilation, MIGS, open-angle glaucoma, glaucoma surgery, canaloplasty, trabeculotomy, OMNIGallardo MJSarkisian SR JrVold SDSingh IPFlowers BECampbell ADhamdhere KSamuelson TWDove Medical Pressarticleviscodilationmigsopen-angle glaucomaglaucoma surgerycanaloplastytrabeculotomyomniOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 481-489 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	viscodilation migs open-angle glaucoma glaucoma surgery canaloplasty trabeculotomy omni Ophthalmology RE1-994
spellingShingle	viscodilation migs open-angle glaucoma glaucoma surgery canaloplasty trabeculotomy omni Ophthalmology RE1-994 Gallardo MJ Sarkisian SR Jr Vold SD Singh IP Flowers BE Campbell A Dhamdhere K Samuelson TW Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study
description	Mark J Gallardo,1 Steven R Sarkisian Jr,2 Steven D Vold,3 Inder Paul Singh,4 Brian E Flowers,5 Anita Campbell,6 Kavita Dhamdhere,7 Thomas W Samuelson8 On behalf of the GEMINI study group1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK, USA; 3Vold Vision, Fayetteville, AR, USA; 4Eye Centers of Racine & Kenosha, Racine, WI, USA; 5Ophthalmology Associates, Fort Worth, TX, USA; 6Grene Vision Group, Wichita, KS, USA; 7Sight Sciences, Menlo Park, CA, USA; 8Minnesota Eye Consultants, Minneapolis, MN, USACorrespondence: Kavita Dhamdhere Email kdhamdhere@sightsciences.comPurpose: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG).Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin).Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤ 33 mmHg on 1 to 4 hypotensive medications.Methods: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline.Results: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥ 6 and ≤ 18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥ 10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI.Conclusion: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.Keywords: viscodilation, MIGS, open-angle glaucoma, glaucoma surgery, canaloplasty, trabeculotomy, OMNI
format	article
author	Gallardo MJ Sarkisian SR Jr Vold SD Singh IP Flowers BE Campbell A Dhamdhere K Samuelson TW
author_facet	Gallardo MJ Sarkisian SR Jr Vold SD Singh IP Flowers BE Campbell A Dhamdhere K Samuelson TW
author_sort	Gallardo MJ
title	Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study
title_short	Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study
title_full	Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study
title_fullStr	Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study
title_full_unstemmed	Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study
title_sort	canaloplasty and trabeculotomy combined with phacoemulsification in open-angle glaucoma: interim results from the gemini study
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/885e80e612134cb28df3267d472d6a23
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Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study

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