Postoperative Complications in the Ahmed Baerveldt Comparison Study during Five Years of Follow-up

Ahmed Baerveldt Comparison Study Group

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Abstract

Purpose To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. Design Multicenter, prospective randomized clinical trial. Methods setting: Sixteen international clinical centers. study population: Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg. interventions: Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350. main outcome measures: Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. Results Late complications developed in 56 subjects (46.8 ± 4.8 5-year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5-year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P =.082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P =.034), although this was largely driven by subjects who had tube occlusions in the 2 groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P =.037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P =.04). Conclusions Long-term rates of vision-threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up.

Original languageEnglish (US)
Pages (from-to)75-82.e3
JournalAmerican journal of ophthalmology
Volume163
DOIs
StatePublished - Mar 1 2016

Bibliographical note

Funding Information:
Funding Support: NIH P30 EY014801 (University of Miami), unrestricted grants from Research to Prevent Blindness , New York, New York, USA (University of North Carolina and University of Miami), and an unrestricted grant from New World Medical, Inc , Rancho Cucamonga, California, USA (University of Miami). Some clinical centers received free implants for the study from New World Medical and from Abbott Medical Optics , Abbott Park, Illinois, USA. Financial disclosures: D. Budenz: Consulting fees– Alcon Labs , Ft Worth, Texas, USA; Travel grant– New World Medical, Inc , Rancho Cucamonga, California, USA; Data Safety Monitoring Board fees– Ivantis , Irvine, California, USA. Research grants– New World Medical Inc ; National Eye Institute (NIH) , Bethesda, Maryland, USA. W. Feuer: Research grants– New World Medical , Rancho Cucamonga, California, USA; National Eye Institute (NIH) , Bethesda, Maryland, USA; Research to Prevent Blindness , New York, NY, USA; Department of Defense , Washington, DC, USA. K. Barton: Consulting fees– Alcon Labs , Ft Worth, Texas, USA; Ivantis , Irvine, California, USA; Aquesys, Aliso Viejo, California, USA. Advisory Board fees– Glaukos , Laguna Hills, California, USA; Kowa , Aichi, Japan; Amakem , Diepenbeek, Belgium; Laboratoires Thea , Clermont-Ferrand, France; Travel grant– New World Medical , Rancho Cucamonga, California, USA; Supplied Implants for research– New World Medical ; Abbott Medical Optics , Abbott Park , Illinois, USA; Research grant– Merck & Co , Kenilworth, New Jersey, USA. Stock and options–Aquesys Inc, Ophthalmic Implants Pte, Vision Futures Ltd, Vision Medical Events Ltd. The following authors have no financial disclosures: J. Schiffman, V. Costa, D. Godfrey, Y. Buys. All authors attest that they meet the current ICMJE criteria for authorship.

Funding Information:
NIH P30 EY014801 (UNIVERSITY OF MIAMI), UNRESTRICTED GRANTS FROM RESEARCH TO PREVENT BLINDness, New York, New York, USA (University of North Carolina and University of Miami), and an unrestricted grant from New World Medical, Inc, Rancho Cucamonga, California, USA (University of Miami). Some clinical centers received free implants for the study from New World Medical and from Abbott Medical Optics, Abbott Park, Illinois, USA. Financial disclosures: D. Budenz: Consulting fees?Alcon Labs, Ft Worth, Texas, USA; Travel grant?New World Medical, Inc, Rancho Cucamonga, California, USA; Data Safety Monitoring Board fees?Ivantis, Irvine, California, USA. Research grants?New World Medical Inc; National Eye Institute (NIH), Bethesda, Maryland, USA. W. Feuer: Research grants?New World Medical, Rancho Cucamonga, California, USA; National Eye Institute (NIH), Bethesda, Maryland, USA; Research to Prevent Blindness, New York, NY, USA; Department of Defense, Washington, DC, USA. K. Barton: Consulting fees?Alcon Labs, Ft Worth, Texas, USA; Ivantis, Irvine, California, USA; Aquesys, Aliso Viejo, California, USA. Advisory Board fees?Glaukos, Laguna Hills, California, USA; Kowa, Aichi, Japan; Amakem, Diepenbeek, Belgium; Laboratoires Thea, Clermont-Ferrand, France; Travel grant?New World Medical, Rancho Cucamonga, California, USA; Supplied Implants for research?New World Medical; Abbott Medical Optics, Abbott Park, Illinois, USA; Research grant?Merck & Co, Kenilworth, New Jersey, USA. Stock and options?Aquesys Inc, Ophthalmic Implants Pte, Vision Futures Ltd, Vision Medical Events Ltd. The following authors have no financial disclosures: J. Schiffman, V. Costa, D. Godfrey, Y. Buys. All authors attest that they meet the current ICMJE criteria for authorship.

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