April 2009
Volume 50, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2009
Ahmed vs. Baerveldt Comparison (ABC) Study Baseline Characteristics and Surgical Complications
Author Affiliations & Notes
  • K. Barton
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
  • D. L. Budenz
    Glaucoma Service, Bascom Palmer Eye Institute, University of Miami, Miami, Florida
  • R. A. Puertas
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
  • J. Schiffman
    Glaucoma Service, Bascom Palmer Eye Institute, University of Miami, Miami, Florida
  • W. J. Feuer
    Glaucoma Service, Bascom Palmer Eye Institute, University of Miami, Miami, Florida
  • The ABC Study Group
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
  • Footnotes
    Commercial Relationships  K. Barton, New World Medical, R; AMO, R; D.L. Budenz, Unrestricted Research Grant from New World Medical, Inc., F; R.A. Puertas, None; J. Schiffman, Unrestricted Research Grant from New World Medical, Inc., F; W.J. Feuer, Unrestricted Research Grant from New World Medical, Inc., F.
  • Footnotes
    Support  Unrestricted grant to the University of Miami, Department of Ophthalmology, from Research to Prevent Blindness, NIH Core Center Grant P30 EY014801
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 441. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      K. Barton, D. L. Budenz, R. A. Puertas, J. Schiffman, W. J. Feuer, The ABC Study Group; Ahmed vs. Baerveldt Comparison (ABC) Study Baseline Characteristics and Surgical Complications. Invest. Ophthalmol. Vis. Sci. 2009;50(13):441.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose: : The ABC Study is a Multi-Centre Randomized Controlled Prospective Clinical Trial that will compare the long-term safety and efficacy of two of the most commonly used aqueous shunts in clinical practice: the Ahmed Glaucoma Valve (AGV) model FP7, and the Baerveldt Glaucoma Implant, (BGI) model 101-350.

Methods: : Setting: 16 clinical centres of which 12 are in the United States and 1 each are in Brazil, Canada, Singapore and the United Kingdom. Study population: Patients aged 18-85years who have uncontrolled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) ≥18mmHg, in whom an aqueous shunt implant is planned and who suffer either from secondary glaucoma with or without previous surgery, or primary glaucoma with previous failed trabeculectomy or other intraocular surgery. Interventions: Study patients were randomized to undergo implantation of an AGV or a BGI. Outcome measures: IOP level, complication rate, visual acuity, visual field, reoperations for glaucoma, change in central corneal thickness and need for additional hypotensive medical therapy.

Results: : 276 patients with age ranging from 24-85years (63±13.7yrs) were recruited and randomised between October 2006 and April 2008: 143 eyes received an AGV and 133, a BGI; 52% were male and 54% right eyes. 134 (48.6%) were white, 58 (24.6%) black, 33 (12.0%) hispanic, 17 (11.9%) asian and 7 (2.5%) others. 110 (39.9%) had POAG, 19 (6.9%) PACG, 79 (28.6%) neovascular, 18 (6.5%) uveitic, and 49 (17.8%) others. 90 (32.6%) were phakic, 181 (65.6%) pseudophakic and 5 (1.8%) aphakic at the time of surgery.The overall baseline IOP was 31.5 ± 11.8mmHg (mean ± SD) on 3.4 ± 1.1 classes of glaucoma drugs before surgery. The median Snellen VA was 20/80 (range 20/15 to LP). There were no significant differences in baseline characteristics between the two study groups. Of 25 study surgeons, 10 had performd < 5 BGI prior to the study and 4 had performed < 5 AGV. All had performed at least 20 of one type of implant. Although there was a statistically significant difference in surgeon experience with the two implants (p=0.014), the intraoperative surgical complication rate, showed no statistical effect when stratified according to surgeon experience.

Conclusions: : The ABC study should yield valuable prospective comparative data on the safety and efficacy of two of the most commonly used aqueous shunts in clinical practice.

Clinical Trial: : www.clinicaltrials.gov NCT00376363

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: prevalence/incidence • intraocular pressure 
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×