Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months
Purpose To examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin. Methods Subjects with POAG naïve to therapy, with intraocular pressure (IOP)...
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| Veröffentlicht in: | Ophthalmology and therapy 2016-12, Vol.5 (2), p.161-172 |
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| creator | Vold, Steven D. Voskanyan, Lilit Tetz, Manfred Auffarth, Gerd Masood, Imran Au, Leon Ahmed, Iqbal Ike K. Saheb, Hady |
| description | Purpose
To examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin.
Methods
Subjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing.
Results
In this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups.
Conclusions
In this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients.
Trial registration: ClinicalTrials.gov identifier, NCT01443988.
Funding
Glaukos Corporation, Laguna Hills, CA. |
| doi_str_mv | 10.1007/s40123-016-0065-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5125126</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1850779922</sourcerecordid><originalsourceid>FETCH-LOGICAL-c569t-9d381adb2bf6d8f7818ed24e8c5290bff4ca94abf7aee6f70f247d4aeab30aa93</originalsourceid><addsrcrecordid>eNqNkt9r1TAUx4sobsz9Ab5IwBdfqvnVJPVBmJtug-kVvT6H0zbt7WiTa9JOrm_-557R65iCIAQSOJ_zPT_yzbKnjL5klOpXSVLGRU6ZyilVRS4eZIeclSJXBTcP92_DZXGQHad0TSnipiilfJwdcK1YyXlxmP386L4PO3LWQ-dDcg35FPsR4o6sts7nJ74bHDkfYK7DCOQz-CaM_Q_EpkA4WUeoXD0PEMnb3RZSIl8m56dEQkSdkCboBkzp_WuymieUcImsNzHM3YYIRT4EP23Sk-xRC0Nyx_v7KPv6_t369CK_Wp1fnp5c5XWhyikvG2EYNBWvWtWYVhtmXMOlM3XBS1q1rayhlFC1GpxTraYtl7qR4KASFKAUR9mbRXc7V6Nramw0wmC3y7w2QG__jPh-Y7twYwvG8SgUeLEXiOHb7NJkxz7VbsARXZiTZaagWpe41_9AhdLcKE4Rff4Xeh3m6HETSEnJlRZGIsUWqsa1pujau74Ztbd2sIsdLNrB3trBCsx5dn_gu4zfn48AX4CEId-5eK_0P1V_AfFGwdg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1844267384</pqid></control><display><type>article</type><title>Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months</title><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Springer Nature OA Free Journals</source><source>PubMed Central</source><creator>Vold, Steven D. ; Voskanyan, Lilit ; Tetz, Manfred ; Auffarth, Gerd ; Masood, Imran ; Au, Leon ; Ahmed, Iqbal Ike K. ; Saheb, Hady</creator><creatorcontrib>Vold, Steven D. ; Voskanyan, Lilit ; Tetz, Manfred ; Auffarth, Gerd ; Masood, Imran ; Au, Leon ; Ahmed, Iqbal Ike K. ; Saheb, Hady</creatorcontrib><description>Purpose
To examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin.
Methods
Subjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing.
Results
In this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups.
Conclusions
In this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients.
Trial registration: ClinicalTrials.gov identifier, NCT01443988.
Funding
Glaukos Corporation, Laguna Hills, CA.</description><identifier>ISSN: 2193-8245</identifier><identifier>EISSN: 2193-6528</identifier><identifier>DOI: 10.1007/s40123-016-0065-3</identifier><identifier>PMID: 27619225</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Internal Medicine ; Medicine ; Medicine & Public Health ; NCT ; NCT01443988 ; Ophthalmology ; Original Research</subject><ispartof>Ophthalmology and therapy, 2016-12, Vol.5 (2), p.161-172</ispartof><rights>The Author(s) 2016</rights><rights>Ophthalmology and Therapy is a copyright of Springer, 2016.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c569t-9d381adb2bf6d8f7818ed24e8c5290bff4ca94abf7aee6f70f247d4aeab30aa93</citedby><cites>FETCH-LOGICAL-c569t-9d381adb2bf6d8f7818ed24e8c5290bff4ca94abf7aee6f70f247d4aeab30aa93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5125126/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5125126/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,861,882,27905,27906,41101,42170,51557,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27619225$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vold, Steven D.</creatorcontrib><creatorcontrib>Voskanyan, Lilit</creatorcontrib><creatorcontrib>Tetz, Manfred</creatorcontrib><creatorcontrib>Auffarth, Gerd</creatorcontrib><creatorcontrib>Masood, Imran</creatorcontrib><creatorcontrib>Au, Leon</creatorcontrib><creatorcontrib>Ahmed, Iqbal Ike K.</creatorcontrib><creatorcontrib>Saheb, Hady</creatorcontrib><title>Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months</title><title>Ophthalmology and therapy</title><addtitle>Ophthalmol Ther</addtitle><addtitle>Ophthalmol Ther</addtitle><description>Purpose
To examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin.
Methods
Subjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing.
Results
In this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups.
Conclusions
In this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients.
Trial registration: ClinicalTrials.gov identifier, NCT01443988.
Funding
Glaukos Corporation, Laguna Hills, CA.</description><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>NCT</subject><subject>NCT01443988</subject><subject>Ophthalmology</subject><subject>Original Research</subject><issn>2193-8245</issn><issn>2193-6528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqNkt9r1TAUx4sobsz9Ab5IwBdfqvnVJPVBmJtug-kVvT6H0zbt7WiTa9JOrm_-557R65iCIAQSOJ_zPT_yzbKnjL5klOpXSVLGRU6ZyilVRS4eZIeclSJXBTcP92_DZXGQHad0TSnipiilfJwdcK1YyXlxmP386L4PO3LWQ-dDcg35FPsR4o6sts7nJ74bHDkfYK7DCOQz-CaM_Q_EpkA4WUeoXD0PEMnb3RZSIl8m56dEQkSdkCboBkzp_WuymieUcImsNzHM3YYIRT4EP23Sk-xRC0Nyx_v7KPv6_t369CK_Wp1fnp5c5XWhyikvG2EYNBWvWtWYVhtmXMOlM3XBS1q1rayhlFC1GpxTraYtl7qR4KASFKAUR9mbRXc7V6Nramw0wmC3y7w2QG__jPh-Y7twYwvG8SgUeLEXiOHb7NJkxz7VbsARXZiTZaagWpe41_9AhdLcKE4Rff4Xeh3m6HETSEnJlRZGIsUWqsa1pujau74Ztbd2sIsdLNrB3trBCsx5dn_gu4zfn48AX4CEId-5eK_0P1V_AfFGwdg</recordid><startdate>20161201</startdate><enddate>20161201</enddate><creator>Vold, Steven D.</creator><creator>Voskanyan, Lilit</creator><creator>Tetz, Manfred</creator><creator>Auffarth, Gerd</creator><creator>Masood, Imran</creator><creator>Au, Leon</creator><creator>Ahmed, Iqbal Ike K.</creator><creator>Saheb, Hady</creator><general>Springer Healthcare</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20161201</creationdate><title>Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months</title><author>Vold, Steven D. ; Voskanyan, Lilit ; Tetz, Manfred ; Auffarth, Gerd ; Masood, Imran ; Au, Leon ; Ahmed, Iqbal Ike K. ; Saheb, Hady</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c569t-9d381adb2bf6d8f7818ed24e8c5290bff4ca94abf7aee6f70f247d4aeab30aa93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>NCT</topic><topic>NCT01443988</topic><topic>Ophthalmology</topic><topic>Original Research</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vold, Steven D.</creatorcontrib><creatorcontrib>Voskanyan, Lilit</creatorcontrib><creatorcontrib>Tetz, Manfred</creatorcontrib><creatorcontrib>Auffarth, Gerd</creatorcontrib><creatorcontrib>Masood, Imran</creatorcontrib><creatorcontrib>Au, Leon</creatorcontrib><creatorcontrib>Ahmed, Iqbal Ike K.</creatorcontrib><creatorcontrib>Saheb, Hady</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Ophthalmology and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vold, Steven D.</au><au>Voskanyan, Lilit</au><au>Tetz, Manfred</au><au>Auffarth, Gerd</au><au>Masood, Imran</au><au>Au, Leon</au><au>Ahmed, Iqbal Ike K.</au><au>Saheb, Hady</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months</atitle><jtitle>Ophthalmology and therapy</jtitle><stitle>Ophthalmol Ther</stitle><addtitle>Ophthalmol Ther</addtitle><date>2016-12-01</date><risdate>2016</risdate><volume>5</volume><issue>2</issue><spage>161</spage><epage>172</epage><pages>161-172</pages><issn>2193-8245</issn><eissn>2193-6528</eissn><abstract>Purpose
To examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin.
Methods
Subjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing.
Results
In this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups.
Conclusions
In this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients.
Trial registration: ClinicalTrials.gov identifier, NCT01443988.
Funding
Glaukos Corporation, Laguna Hills, CA.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>27619225</pmid><doi>10.1007/s40123-016-0065-3</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Springer Nature OA Free Journals; PubMed Central |
| subjects | Internal Medicine Medicine Medicine & Public Health NCT NCT01443988 Ophthalmology Original Research |
| title | Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months |
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