Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent
PURPOSE:To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery. PATIENTS AND METHODS:Subjects (n=142) with open-angle glaucoma and cataract underwent combined p...
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| Veröffentlicht in: | Journal of glaucoma 2016-01, Vol.25 (1), p.106-112 |
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| container_title | Journal of glaucoma |
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| creator | Hoeh, Helmut Vold, Steven D Ahmed, Iqbal K Anton, Alfonso Rau, Magda Singh, Kuldev Chang, David F Shingleton, Bradford J Ianchulev, Tsontcho |
| description | PURPOSE:To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery.
PATIENTS AND METHODS:Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP)≥21 mm Hg (cohort 1, n=65) or |
| doi_str_mv | 10.1097/IJG.0000000000000134 |
| format | Article |
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PATIENTS AND METHODS:Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP)≥21 mm Hg (cohort 1, n=65) or <21 mm Hg (cohort 2, n=102). Glaucoma medications were discontinued or tapered at surgery, and restarted at investigator discretion. The main postoperative outcome measures were adverse events, IOP changes, and number of IOP-lowering medications.
RESULTS:Mean±SD follow-up was 294±121 days. No major intraoperative or postoperative complications occurred. Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP-lowering medications was 2.0±1.1. Cohort 1 showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage; cohort 2 demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline). Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes, respectively. Two subjects developed mild transient hyphema, and none exhibited prolonged inflammation, persistent hypotony, or hypotony maculopathy.
CONCLUSIONS:CyPass Micro-Stent implantation, combined with cataract surgery, resulted in minimal complications and reduced IOP and IOP-lowering medication use at 12 months postoperatively.</description><identifier>ISSN: 1057-0829</identifier><identifier>EISSN: 1536-481X</identifier><identifier>DOI: 10.1097/IJG.0000000000000134</identifier><identifier>PMID: 25304276</identifier><language>eng</language><publisher>United States: Copyright Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Aged ; Aged, 80 and over ; Cataract - complications ; Female ; Glaucoma Drainage Implants ; Glaucoma, Open-Angle - physiopathology ; Glaucoma, Open-Angle - surgery ; Humans ; Intraocular Pressure - physiology ; Male ; Middle Aged ; Phacoemulsification ; Postoperative Complications ; Tonometry, Ocular ; Treatment Outcome ; Visual Acuity - physiology</subject><ispartof>Journal of glaucoma, 2016-01, Vol.25 (1), p.106-112</ispartof><rights>Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3054-18d7f92e50d37ffe42dcc8cef3264833506e6f73190c1af027239570894937053</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25304276$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hoeh, Helmut</creatorcontrib><creatorcontrib>Vold, Steven D</creatorcontrib><creatorcontrib>Ahmed, Iqbal K</creatorcontrib><creatorcontrib>Anton, Alfonso</creatorcontrib><creatorcontrib>Rau, Magda</creatorcontrib><creatorcontrib>Singh, Kuldev</creatorcontrib><creatorcontrib>Chang, David F</creatorcontrib><creatorcontrib>Shingleton, Bradford J</creatorcontrib><creatorcontrib>Ianchulev, Tsontcho</creatorcontrib><title>Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent</title><title>Journal of glaucoma</title><addtitle>J Glaucoma</addtitle><description>PURPOSE:To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery.
PATIENTS AND METHODS:Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP)≥21 mm Hg (cohort 1, n=65) or <21 mm Hg (cohort 2, n=102). Glaucoma medications were discontinued or tapered at surgery, and restarted at investigator discretion. The main postoperative outcome measures were adverse events, IOP changes, and number of IOP-lowering medications.
RESULTS:Mean±SD follow-up was 294±121 days. No major intraoperative or postoperative complications occurred. Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP-lowering medications was 2.0±1.1. Cohort 1 showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage; cohort 2 demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline). Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes, respectively. Two subjects developed mild transient hyphema, and none exhibited prolonged inflammation, persistent hypotony, or hypotony maculopathy.
CONCLUSIONS:CyPass Micro-Stent implantation, combined with cataract surgery, resulted in minimal complications and reduced IOP and IOP-lowering medication use at 12 months postoperatively.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Cataract - complications</subject><subject>Female</subject><subject>Glaucoma Drainage Implants</subject><subject>Glaucoma, Open-Angle - physiopathology</subject><subject>Glaucoma, Open-Angle - surgery</subject><subject>Humans</subject><subject>Intraocular Pressure - physiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Phacoemulsification</subject><subject>Postoperative Complications</subject><subject>Tonometry, Ocular</subject><subject>Treatment Outcome</subject><subject>Visual Acuity - physiology</subject><issn>1057-0829</issn><issn>1536-481X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UE1P3DAUtBAVX-UfoMpHLoFnO44Tbmi10EUUKm0R3CLjPHcN3mSxncL--2ZZWiEOvMsb6c3MGw0hBwyOGFTqeHJxfgTvh4l8g-wwKYosL9nd5oBBqgxKXm2T3RgfADhwzrbINpcCcq6KHfIyaV1y2tORd60zAxi_LDA4bA3SW5dmNM2QjpY_dYz0hzOhy6YJ23RCp9piWlLdNnTah9-v2us-mW6OkXaWanrV_UE_HBdBG-edDsu1Q1wZfCVfrPYR99_2Hrk5G_8afc8ur88no9PLzAiQecbKRtmKo4RGKGsx540xpUEreJGXQkgosLBKsAoM0xa44qKSCsoqr4QCKfbI4dp3EbqnHmOq5y4a9F632PWxZkqyQgFTxUDN19RVxhjQ1ovg5kPsmkG96rweOq8_dj7Ivr196O_n2PwX_St5IJRrwnPnE4b46PtnDPUMtU-zz73_AhQQjNY</recordid><startdate>201601</startdate><enddate>201601</enddate><creator>Hoeh, Helmut</creator><creator>Vold, Steven D</creator><creator>Ahmed, Iqbal K</creator><creator>Anton, Alfonso</creator><creator>Rau, Magda</creator><creator>Singh, Kuldev</creator><creator>Chang, David F</creator><creator>Shingleton, Bradford J</creator><creator>Ianchulev, Tsontcho</creator><general>Copyright Wolters Kluwer Health, Inc. All rights reserved</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201601</creationdate><title>Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent</title><author>Hoeh, Helmut ; Vold, Steven D ; Ahmed, Iqbal K ; Anton, Alfonso ; Rau, Magda ; Singh, Kuldev ; Chang, David F ; Shingleton, Bradford J ; Ianchulev, Tsontcho</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3054-18d7f92e50d37ffe42dcc8cef3264833506e6f73190c1af027239570894937053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Cataract - complications</topic><topic>Female</topic><topic>Glaucoma Drainage Implants</topic><topic>Glaucoma, Open-Angle - physiopathology</topic><topic>Glaucoma, Open-Angle - surgery</topic><topic>Humans</topic><topic>Intraocular Pressure - physiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Phacoemulsification</topic><topic>Postoperative Complications</topic><topic>Tonometry, Ocular</topic><topic>Treatment Outcome</topic><topic>Visual Acuity - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hoeh, Helmut</creatorcontrib><creatorcontrib>Vold, Steven D</creatorcontrib><creatorcontrib>Ahmed, Iqbal K</creatorcontrib><creatorcontrib>Anton, Alfonso</creatorcontrib><creatorcontrib>Rau, Magda</creatorcontrib><creatorcontrib>Singh, Kuldev</creatorcontrib><creatorcontrib>Chang, David F</creatorcontrib><creatorcontrib>Shingleton, Bradford J</creatorcontrib><creatorcontrib>Ianchulev, Tsontcho</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of glaucoma</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hoeh, Helmut</au><au>Vold, Steven D</au><au>Ahmed, Iqbal K</au><au>Anton, Alfonso</au><au>Rau, Magda</au><au>Singh, Kuldev</au><au>Chang, David F</au><au>Shingleton, Bradford J</au><au>Ianchulev, Tsontcho</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent</atitle><jtitle>Journal of glaucoma</jtitle><addtitle>J Glaucoma</addtitle><date>2016-01</date><risdate>2016</risdate><volume>25</volume><issue>1</issue><spage>106</spage><epage>112</epage><pages>106-112</pages><issn>1057-0829</issn><eissn>1536-481X</eissn><abstract>PURPOSE:To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery.
PATIENTS AND METHODS:Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP)≥21 mm Hg (cohort 1, n=65) or <21 mm Hg (cohort 2, n=102). Glaucoma medications were discontinued or tapered at surgery, and restarted at investigator discretion. The main postoperative outcome measures were adverse events, IOP changes, and number of IOP-lowering medications.
RESULTS:Mean±SD follow-up was 294±121 days. No major intraoperative or postoperative complications occurred. Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP-lowering medications was 2.0±1.1. Cohort 1 showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage; cohort 2 demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline). Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes, respectively. Two subjects developed mild transient hyphema, and none exhibited prolonged inflammation, persistent hypotony, or hypotony maculopathy.
CONCLUSIONS:CyPass Micro-Stent implantation, combined with cataract surgery, resulted in minimal complications and reduced IOP and IOP-lowering medication use at 12 months postoperatively.</abstract><cop>United States</cop><pub>Copyright Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>25304276</pmid><doi>10.1097/IJG.0000000000000134</doi><tpages>7</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Cataract - complications Female Glaucoma Drainage Implants Glaucoma, Open-Angle - physiopathology Glaucoma, Open-Angle - surgery Humans Intraocular Pressure - physiology Male Middle Aged Phacoemulsification Postoperative Complications Tonometry, Ocular Treatment Outcome Visual Acuity - physiology |
| title | Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent |
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