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The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

AbstractPURPOSE:
The Ahmed Baerveldt Comparison (ABC) Study compares the long-term outcomes and complications of the Ahmed glaucoma valve (AGV; model FP7; New World Medical, Los Ranchos, CA) and the Baerveldt glaucoma implant (BGI; model 101-350; Abbott Medical Optics, Abbott Park, IL).
DESIGN:
Multicenter, randomized, controlled clinical trial.
PARTICIPANTS:
Two hundred seventy-six glaucoma patients at 16 clinical centers worldwide who were 18 to 85 years of age with inadequately controlled intraocular pressure (IOP; ≥18 mmHg) in whom placement of an aqueous shunt was planned.
METHODS:
Study patients were randomized to undergo implantation of an AGV or a BGI.
MAIN OUTCOME MEASURES:
Failure, defined as IOP >21 mmHg or not reduced by 20% less than baseline or IOP ≤5 mmHg (2 consecutive visits after 3 months), additional glaucoma surgery, removal of the implant, or loss of light perception vision.
RESULTS:
A total of 276 patients were enrolled between October 2006 and April 2008, including 143 in the AGV group and 133 in the BGI group. The mean age±standard deviation (SD) of patients enrolled was 63±14 years, and 52% were male. The mean baseline IOP±SD was 31.5±11.8 mmHg. Except for a 13% higher prevalence of hypertension in the AGV group, no significant differences in baseline demographic or ocular characteristics were observed between the study groups. Intraoperative complications occurred in 11 (8%) patients in the AGV group and in 16 (12%) patients in the BGI group (P = 0.31).
CONCLUSIONS:
The ABC Study should yield valuable prospective data comparing 2 commonly used aqueous shunts in clinical practice.
AuthorsKeith Barton, Steven J Gedde, Donald L Budenz, William J Feuer, Joyce Schiffman, Ahmed Baerveldt Comparison Study Group
JournalOphthalmology (Ophthalmology) Vol. 118 Issue 3 Pg. 435-42 (Mar 2011) ISSN: 1549-4713 [Electronic] United States
PMID20932581 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Aqueous Humor (metabolism)
  • Eye Movements (physiology)
  • Female
  • Follow-Up Studies
  • Glaucoma (physiopathology, surgery)
  • Glaucoma Drainage Implants
  • Gonioscopy
  • Humans
  • Intraocular Pressure (physiology)
  • Intraoperative Complications
  • Male
  • Middle Aged
  • Prosthesis Implantation
  • Refraction, Ocular (physiology)
  • Tonometry, Ocular
  • Treatment Outcome
  • Visual Acuity (physiology)
  • Visual Field Tests
  • Young Adult

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