Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up
Purpose To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma. Design Multicenter, randomized,...
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| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 2011-03, Vol.118 (3), p.443-452 |
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| creator | Budenz, Donald L., MD, MPH Barton, Keith, MD Feuer, William J., MS Schiffman, Joyce, MS Costa, Vital P., MD Godfrey, David G., MD Buys, Yvonne M., MD |
| description | Purpose To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. Main Outcome Measures The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. Results Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group ( P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group ( P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group ( P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year ( P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group ( P = 0.014). Conclusions Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references. |
| doi_str_mv | 10.1016/j.ophtha.2010.07.016 |
| format | Article |
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Design Multicenter, randomized, controlled clinical trial. Participants Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. Main Outcome Measures The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. Results Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group ( P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group ( P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group ( P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year ( P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group ( P = 0.014). Conclusions Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2010.07.016</identifier><identifier>PMID: 20932583</identifier><identifier>CODEN: OPHTDG</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Device Removal ; Female ; Follow-Up Studies ; Glaucoma - physiopathology ; Glaucoma - surgery ; Glaucoma Drainage Implants ; Humans ; Intraocular Pressure - physiology ; Intraoperative Complications ; Male ; Medical sciences ; Middle Aged ; Miscellaneous ; Ophthalmology ; Postoperative Complications ; Prospective Studies ; Prosthesis Implantation ; Reoperation ; Tonometry, Ocular ; Treatment Outcome ; Visual Acuity - physiology ; Young Adult</subject><ispartof>Ophthalmology (Rochester, Minn.), 2011-03, Vol.118 (3), p.443-452</ispartof><rights>American Academy of Ophthalmology</rights><rights>2011 American Academy of Ophthalmology</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c492t-bbde7fa85e32d0f039842c13f0dec039408c346885279516175c1032cf1094023</citedby><cites>FETCH-LOGICAL-c492t-bbde7fa85e32d0f039842c13f0dec039408c346885279516175c1032cf1094023</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ophtha.2010.07.016$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3549,27923,27924,45994</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23939686$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20932583$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Budenz, Donald L., MD, MPH</creatorcontrib><creatorcontrib>Barton, Keith, MD</creatorcontrib><creatorcontrib>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>Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>Purpose To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. Main Outcome Measures The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. Results Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group ( P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group ( P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group ( P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year ( P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group ( P = 0.014). Conclusions Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Device Removal</subject><subject>Female</subject><subject>Follow-Up Studies</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>Medical sciences</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Ophthalmology</subject><subject>Postoperative Complications</subject><subject>Prospective Studies</subject><subject>Prosthesis Implantation</subject><subject>Reoperation</subject><subject>Tonometry, Ocular</subject><subject>Treatment Outcome</subject><subject>Visual Acuity - physiology</subject><subject>Young Adult</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUtv1DAUhS0EotPCP0DIG8Qqw_Urjw1SO6IFqVIXHRasLI9zo_GQxMF2iubf42gGkNiwsnx87sPfIeQNgzUDVn44rP20T3uz5pAlqNZZfEZWTMmmkBUTz8kqK6woJYcLchnjAQDKUsiX5IJDI7iqxYpstwFNGnBM9GFO1g8YqRtp2iO93g_Y0huD4Qn7NtGNHyYTXPQjfUxze6SmSxgoo9_QBOo7euv73v8s5ukVedGZPuLr83lFvt5-2m4-F_cPd1821_eFlQ1PxW7XYtWZWqHgLXQgmlpyy0QHLdp8k1BbIcu6VrxqVP5LpSwDwW3HID9ycUXen_pOwf-YMSY9uGix782Ifo66VqoBJfnilCenDT7GgJ2eghtMOGoGesGpD_qEUy84NVQ6i7ns7XnAvMsw_hT95pcN784GE63pu2BG6-Jfn2hEU9ZLo48nH2YcTw6DjtbhaLF1AW3SrXf_2-TfBrZ3o8szv-MR48HPYcyoNdORa9CPS_RL8iyHXikB4hcno6es</recordid><startdate>20110301</startdate><enddate>20110301</enddate><creator>Budenz, Donald L., MD, MPH</creator><creator>Barton, Keith, 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><general>Elsevier</general><scope>IQODW</scope><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>20110301</creationdate><title>Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up</title><author>Budenz, Donald L., MD, MPH ; Barton, Keith, 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-c492t-bbde7fa85e32d0f039842c13f0dec039408c346885279516175c1032cf1094023</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Device Removal</topic><topic>Female</topic><topic>Follow-Up Studies</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>Medical sciences</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Ophthalmology</topic><topic>Postoperative Complications</topic><topic>Prospective Studies</topic><topic>Prosthesis Implantation</topic><topic>Reoperation</topic><topic>Tonometry, Ocular</topic><topic>Treatment Outcome</topic><topic>Visual Acuity - physiology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Budenz, Donald L., MD, MPH</creatorcontrib><creatorcontrib>Barton, Keith, 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>Pascal-Francis</collection><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>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>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>Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2011-03-01</date><risdate>2011</risdate><volume>118</volume><issue>3</issue><spage>443</spage><epage>452</epage><pages>443-452</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><coden>OPHTDG</coden><abstract>Purpose To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma. Design Multicenter, randomized, controlled clinical trial. Participants Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. Main Outcome Measures The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. Results Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group ( P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group ( P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group ( P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year ( P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group ( P = 0.014). Conclusions Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>20932583</pmid><doi>10.1016/j.ophtha.2010.07.016</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over Biological and medical sciences Device Removal Female Follow-Up Studies Glaucoma - physiopathology Glaucoma - surgery Glaucoma Drainage Implants Humans Intraocular Pressure - physiology Intraoperative Complications Male Medical sciences Middle Aged Miscellaneous Ophthalmology Postoperative Complications Prospective Studies Prosthesis Implantation Reoperation Tonometry, Ocular Treatment Outcome Visual Acuity - physiology Young Adult |
| title | Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up |
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