Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study
Purpose To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. Design Multicenter, randomized, controlled clinical tria...
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| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 2015-02, Vol.122 (2), p.308-316 |
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| creator | Budenz, Donald L., MD, MPH Barton, Keith, MD Gedde, Steven J., MD Feuer, William J., MS Schiffman, Joyce, MS Costa, Vital P., MD Godfrey, David G., MD Buys, Yvonne M., MD |
| description | Purpose To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants A total of 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI. Main Outcome Measures Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications. Results At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group ( P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group ( P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group ( P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group ( P = 0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues. |
| doi_str_mv | 10.1016/j.ophtha.2014.08.043 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4306613</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0161642014008124</els_id><sourcerecordid>1652428461</sourcerecordid><originalsourceid>FETCH-LOGICAL-c584t-e712e9d3b0d7630235ac3334a5946d9f962663f22088d3e4394187fc4ae7736e3</originalsourceid><addsrcrecordid>eNqFkk1v1DAQhi0EosvCP0AoRy4J_oqTXJDKQlukSj20HDiNXHtCvCTxYjsr7b_Hqy3l48LJB7_zzjvzDCGvGa0YZerdtvK7IQ264pTJirYVleIJWbFadqVsmHhKVlnGSiU5PSMvYtxSSpUS8jk547UUnaJqRT5euD2WX1GH4i6gThPOqbhZkvETxsLNRRqwOB8mtMUHjWGPo03Fxk87HVz0c3GbFnt4SZ71eoz46uFdky8Xn-42V-X1zeXnzfl1aepWphIbxrGz4p7aRgnKRa2NEELqupPKdn2neM7Xc07b1grMESVrm95IjU0jFIo1eX_y3S33OZHJWYMeYRfcpMMBvHbw98_sBvjm9yBFnpyJbPD2wSD4HwvGBJOLBsdRz-iXCEzVXPJWZu2ayJPUBB9jwP6xDaNwBABbOAGAIwCgLWQAuezNnxEfi35t_PcMmBe1dxggGoezQesCmgTWu_91-NfAjG52Ro_f8YBx65cwZwjAIHKgcHs8guMNMElpy7gUPwHOSq0m</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1652428461</pqid></control><display><type>article</type><title>Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Budenz, Donald L., MD, MPH ; Barton, Keith, MD ; Gedde, Steven J., MD ; Feuer, William J., MS ; Schiffman, Joyce, MS ; Costa, Vital P., MD ; Godfrey, David G., MD ; Buys, Yvonne M., MD</creator><creatorcontrib>Budenz, Donald L., MD, MPH ; Barton, Keith, MD ; Gedde, Steven J., MD ; Feuer, William J., MS ; Schiffman, Joyce, MS ; Costa, Vital P., MD ; Godfrey, David G., MD ; Buys, Yvonne M., MD ; Ahmed Baerveldt Comparison Study Group</creatorcontrib><description>Purpose To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants A total of 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI. Main Outcome Measures Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications. Results At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group ( P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group ( P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group ( P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group ( P = 0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2014.08.043</identifier><identifier>PMID: 25439606</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antihypertensive Agents - administration & dosage ; Female ; Glaucoma - physiopathology ; Glaucoma - surgery ; Glaucoma Drainage Implants ; Humans ; Intraocular Pressure - physiology ; Intraoperative Complications ; Male ; Middle Aged ; Ophthalmology ; Postoperative Complications ; Prosthesis Implantation ; Reoperation ; Tonometry, Ocular ; Trabeculectomy ; Treatment Failure ; Treatment Outcome ; Visual Acuity - physiology</subject><ispartof>Ophthalmology (Rochester, Minn.), 2015-02, Vol.122 (2), p.308-316</ispartof><rights>American Academy of Ophthalmology</rights><rights>2015 American Academy of Ophthalmology</rights><rights>Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.</rights><rights>2014 by the American Academy of Ophthalmology. All rights reserved. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c584t-e712e9d3b0d7630235ac3334a5946d9f962663f22088d3e4394187fc4ae7736e3</citedby><cites>FETCH-LOGICAL-c584t-e712e9d3b0d7630235ac3334a5946d9f962663f22088d3e4394187fc4ae7736e3</cites><orcidid>0000-0001-9345-7410 ; 0000-0002-1787-1000</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0161642014008124$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25439606$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Budenz, Donald L., MD, MPH</creatorcontrib><creatorcontrib>Barton, Keith, MD</creatorcontrib><creatorcontrib>Gedde, Steven J., MD</creatorcontrib><creatorcontrib>Feuer, William J., MS</creatorcontrib><creatorcontrib>Schiffman, Joyce, MS</creatorcontrib><creatorcontrib>Costa, Vital P., MD</creatorcontrib><creatorcontrib>Godfrey, David G., MD</creatorcontrib><creatorcontrib>Buys, Yvonne M., MD</creatorcontrib><creatorcontrib>Ahmed Baerveldt Comparison Study Group</creatorcontrib><title>Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>Purpose To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants A total of 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI. Main Outcome Measures Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications. Results At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group ( P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group ( P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group ( P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group ( P = 0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antihypertensive Agents - administration & dosage</subject><subject>Female</subject><subject>Glaucoma - physiopathology</subject><subject>Glaucoma - surgery</subject><subject>Glaucoma Drainage Implants</subject><subject>Humans</subject><subject>Intraocular Pressure - physiology</subject><subject>Intraoperative Complications</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Ophthalmology</subject><subject>Postoperative Complications</subject><subject>Prosthesis Implantation</subject><subject>Reoperation</subject><subject>Tonometry, Ocular</subject><subject>Trabeculectomy</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><subject>Visual Acuity - physiology</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkk1v1DAQhi0EosvCP0AoRy4J_oqTXJDKQlukSj20HDiNXHtCvCTxYjsr7b_Hqy3l48LJB7_zzjvzDCGvGa0YZerdtvK7IQ264pTJirYVleIJWbFadqVsmHhKVlnGSiU5PSMvYtxSSpUS8jk547UUnaJqRT5euD2WX1GH4i6gThPOqbhZkvETxsLNRRqwOB8mtMUHjWGPo03Fxk87HVz0c3GbFnt4SZ71eoz46uFdky8Xn-42V-X1zeXnzfl1aepWphIbxrGz4p7aRgnKRa2NEELqupPKdn2neM7Xc07b1grMESVrm95IjU0jFIo1eX_y3S33OZHJWYMeYRfcpMMBvHbw98_sBvjm9yBFnpyJbPD2wSD4HwvGBJOLBsdRz-iXCEzVXPJWZu2ayJPUBB9jwP6xDaNwBABbOAGAIwCgLWQAuezNnxEfi35t_PcMmBe1dxggGoezQesCmgTWu_91-NfAjG52Ro_f8YBx65cwZwjAIHKgcHs8guMNMElpy7gUPwHOSq0m</recordid><startdate>20150201</startdate><enddate>20150201</enddate><creator>Budenz, Donald L., MD, MPH</creator><creator>Barton, Keith, MD</creator><creator>Gedde, Steven J., MD</creator><creator>Feuer, William J., MS</creator><creator>Schiffman, Joyce, MS</creator><creator>Costa, Vital P., MD</creator><creator>Godfrey, David G., MD</creator><creator>Buys, Yvonne M., MD</creator><general>Elsevier Inc</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><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-9345-7410</orcidid><orcidid>https://orcid.org/0000-0002-1787-1000</orcidid></search><sort><creationdate>20150201</creationdate><title>Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study</title><author>Budenz, Donald L., MD, MPH ; Barton, Keith, MD ; Gedde, Steven J., MD ; Feuer, William J., MS ; Schiffman, Joyce, MS ; Costa, Vital P., MD ; Godfrey, David G., MD ; Buys, Yvonne M., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c584t-e712e9d3b0d7630235ac3334a5946d9f962663f22088d3e4394187fc4ae7736e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antihypertensive Agents - administration & dosage</topic><topic>Female</topic><topic>Glaucoma - physiopathology</topic><topic>Glaucoma - surgery</topic><topic>Glaucoma Drainage Implants</topic><topic>Humans</topic><topic>Intraocular Pressure - physiology</topic><topic>Intraoperative Complications</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Ophthalmology</topic><topic>Postoperative Complications</topic><topic>Prosthesis Implantation</topic><topic>Reoperation</topic><topic>Tonometry, Ocular</topic><topic>Trabeculectomy</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><topic>Visual Acuity - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Budenz, Donald L., MD, MPH</creatorcontrib><creatorcontrib>Barton, Keith, MD</creatorcontrib><creatorcontrib>Gedde, Steven J., MD</creatorcontrib><creatorcontrib>Feuer, William J., MS</creatorcontrib><creatorcontrib>Schiffman, Joyce, MS</creatorcontrib><creatorcontrib>Costa, Vital P., MD</creatorcontrib><creatorcontrib>Godfrey, David G., MD</creatorcontrib><creatorcontrib>Buys, Yvonne M., MD</creatorcontrib><creatorcontrib>Ahmed Baerveldt Comparison Study Group</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Budenz, Donald L., MD, MPH</au><au>Barton, Keith, MD</au><au>Gedde, Steven J., MD</au><au>Feuer, William J., MS</au><au>Schiffman, Joyce, MS</au><au>Costa, Vital P., MD</au><au>Godfrey, David G., MD</au><au>Buys, Yvonne M., MD</au><aucorp>Ahmed Baerveldt Comparison Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2015-02-01</date><risdate>2015</risdate><volume>122</volume><issue>2</issue><spage>308</spage><epage>316</epage><pages>308-316</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><abstract>Purpose To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants A total of 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI. Main Outcome Measures Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications. Results At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group ( P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group ( P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group ( P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group ( P = 0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25439606</pmid><doi>10.1016/j.ophtha.2014.08.043</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-9345-7410</orcidid><orcidid>https://orcid.org/0000-0002-1787-1000</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Adult Aged Aged, 80 and over Antihypertensive Agents - administration & dosage Female Glaucoma - physiopathology Glaucoma - surgery Glaucoma Drainage Implants Humans Intraocular Pressure - physiology Intraoperative Complications Male Middle Aged Ophthalmology Postoperative Complications Prosthesis Implantation Reoperation Tonometry, Ocular Trabeculectomy Treatment Failure Treatment Outcome Visual Acuity - physiology |
| title | Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study |
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