{"id":463,"date":"2019-03-14T22:48:24","date_gmt":"2019-03-14T19:48:24","guid":{"rendered":"https:\/\/www.sightsciences.com\/ous\/?p=463"},"modified":"2019-03-14T22:48:24","modified_gmt":"2019-03-14T19:48:24","slug":"clinical-study-demonstrates-long-term-iop-reduction-with-the-omni-surgical-system-predicate-device-trab360-in-micro-invasive-glaucoma-surgery","status":"publish","type":"post","link":"https:\/\/www.sightsciences.com\/ous\/clinical-study-demonstrates-long-term-iop-reduction-with-the-omni-surgical-system-predicate-device-trab360-in-micro-invasive-glaucoma-surgery\/","title":{"rendered":"Clinical Study Demonstrates Long Term IOP Reduction With The OMNI\u2122 Surgical System Predicate Device (TRAB\u2122360) In Micro-Invasive Glaucoma Surgery"},"content":{"rendered":"<p>A new, single center retrospective study of glaucoma surgery patients published in the January 2019 issue of Clinical Ophthalmology shows that ab-interno trabeculotomy using one of Sight Sciences\u2019 OMNI\u2122 Surgical System\u2019s Predicate Devices (TRAB\u2122360) provides a favorable safety profile and substantial long-term reductions in both intraocular pressure (IOP) and IOP-lowering medications. Conducted by Steven Sarkisian, M.D., at the Dean A. McGee Eye Institute, the consecutive case series included data on a total of 81 eyes from 69 glaucoma patients undergoing standalone micro-invasive trabeculotomy.* Nearly two-thirds of the eyes (50\/81, 61.7 percent) had undergone prior glaucoma surgery.<\/p>\n<p>\u201cWe are excited to announce the first publication of long-term clinical data on micro-invasive trabeculotomy with one of the OMNI\u2122 Surgical System\u2019s two predicate devices, the TRAB\u2122360,\u201d said Paul Badawi, Founder and Chief Executive Officer of Sight Sciences. \u201cDr. Sarkisian was the first surgeon in the world to perform single incision 360-degree trabeculotomy in 2013, so this is a major milestone recognizing his pioneering work in circumferential canal-based MIGS.\u201d<\/p>\n<p>Key study findings through the 12-month endpoint include:<\/p>\n<ul>\n<li>Standalone glaucoma surgery on all patients.<\/li>\n<li><strong>3mmHg mean IOP reduction<\/strong>from a mean medicated baseline IOP of 23.7mmHg to a mean 12-month IOP of 15.7mmHg.<\/li>\n<li>67 percent of eyes with preoperative IOP values of \u226525 mmHg achieved \u226520 percent reduction in IOP and IOP &lt;18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline.<\/li>\n<li>The most common adverse event was transient hyphema (50.6%); 90 percent of these cases were classified as mild.<\/li>\n<\/ul>\n<p>\u201cThe findings of this study are consistent with the historical body of literature on the long-term safety and efficacy of circumferential trabeculotomy in adults,\u201d said Dr. Sarkisian. \u201cPerformed in a tertiary care setting, these surgeries represent an advanced and clinically diverse patient population including POAG, pigmentary glaucoma, congenital glaucoma, neovascular glaucoma, and other types of glaucoma.\u201d<\/p>\n<p>The OMNI<sup>\u00ae<\/sup>\u00a0Surgical System is a next-generation technology that combines the distinct functions of its two predicate devices \u2013 TRAB\u2122360 for trabeculotomy and VISCO360\u2122 for transluminal viscoelastic delivery \u2013 into one device so that all three sources of resistance in the conventional outflow pathway (trabecular meshwork, Schlemm\u2019s canal, and collector channels) can be targeted with a single device and single surgery.<\/p>\n<p>\u201cWith the recent evolution from the single purpose TRAB\u2122360 trabeculotomy device that I have been using for years to the multi-functional OMNI\u2122 Surgical System, I am pleased to offer my patients two sequential procedures in one surgical setting that can target all three sources of potential resistance in the conventional outflow pathway,\u201d said Dr. Sarkisian.<\/p>\n<p>* Sarkisian SR, Mathews B, Ding K, Patel A, Nicek Z. 360\u02da ab-interno trabeculotomy in refractory primary open-angle glaucoma. Clin Ophthalmol. 2019;13:161-168. Dr. Sarkisian is a consultant to and equity owner in Sight Sciences. This research was supported by a grant from Sight Sciences, Inc.<\/p>\n<p><strong>About OMNI<\/strong><\/p>\n<p>The OMNI\u2122 Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon\u2122 or HealonGV\u2122 from Abbott Medical Optics (AMO), Amvisc\u2122 from Bausch &amp; Lomb, or PROVISC\u2122 from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI\u2122 System should not be used in cases where there is insufficient visualization of the anterior chamber. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit surgeon view.<\/p>\n<p><strong>About TRAB360<\/strong><\/p>\n<p>The TRAB\u2122360 Trabeculotomy System is a trabeculotome, a manual surgical ophthalmic instrument used to mechanically cut trabecular meshwork.<\/p>\n<p>The OMNI\u2122 Surgical System and TRAB\u2122360 Trabeculotomy System are tools, not treatments, and are indicated for use as specified above; they are not specifically cleared by the FDA to lower intraocular pressure in patients with open angle glaucoma.<\/p>\n<p>For more information, including warnings and precautions, please visit\u00a0<a href=\"https:\/\/www.omnisurgical.com\/\">www.omnisurgical.com<\/a>.<\/p>\n<p><strong>About Sight Sciences<\/strong><\/p>\n<p>Sight Sciences is a commercial-stage medical device company dedicated to the development of intelligently designed and engineered products that address the underlying physiology of ophthalmic diseases. The Company\u2019s surgical glaucoma product portfolio features the OMNI\u2122 Surgical System and its predecessor devices VISCO360\u2122 and TRAB\u2122360. Its non-surgical dry eye product portfolio consists of the TearCare\u2122 for ophthalmologists and optometrists. For more information, please visit\u00a0<a href=\"https:\/\/sightsciences.com\/us\/sightsciences\/\">sightsciences.com<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A new, single center retrospective study of glaucoma surgery patients published in the January 2019 issue of Clinical Ophthalmology shows that ab-interno trabeculotomy using one of Sight Sciences\u2019 OMNI\u2122 Surgical System\u2019s Predicate Devices (TRAB\u2122360) provides a favorable safety profile and substantial long-term reductions in both intraocular pressure (IOP) and IOP-lowering medications. Conducted by Steven Sarkisian, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-463","post","type-post","status-publish","format-standard","hentry","category-omni"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.1 (Yoast SEO v27.1.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Clinical Study Demonstrates Long Term IOP Reduction With The OMNI\u2122 Surgical System Predicate Device (TRAB\u2122360) In Micro-Invasive Glaucoma Surgery - International<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sightsciences.com\/ous\/clinical-study-demonstrates-long-term-iop-reduction-with-the-omni-surgical-system-predicate-device-trab360-in-micro-invasive-glaucoma-surgery\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Study Demonstrates Long Term IOP Reduction With The OMNI\u2122 Surgical System Predicate Device (TRAB\u2122360) In Micro-Invasive Glaucoma Surgery\" \/>\n<meta property=\"og:description\" content=\"A new, single center retrospective study of glaucoma surgery patients published in the January 2019 issue of Clinical Ophthalmology shows that ab-interno trabeculotomy using one of Sight Sciences\u2019 OMNI\u2122 Surgical System\u2019s Predicate Devices (TRAB\u2122360) provides a favorable safety profile and substantial long-term reductions in both intraocular pressure (IOP) and IOP-lowering medications. 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