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Randomized Controlled Trial
. 2015 Feb;122(2):308-16.
doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.

Five-year treatment outcomes in the Ahmed Baerveldt comparison study

Donald L Budenz  1 , Keith Barton  2 , Steven J Gedde  3 , William J Feuer  3 , Joyce Schiffman  3 , Vital P Costa  4 , David G Godfrey  5 , Yvonne M Buys  6 ; Ahmed Baerveldt Comparison Study Group
Affiliations
Randomized Controlled Trial

Five-year treatment outcomes in the Ahmed Baerveldt comparison study

Donald L Budenz et al. Ophthalmology. 2015 Feb.

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.

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Conflict of interest statement

Conflict of Interest: No conflicting relationship exists for any author

Figures

Figure 1
Figure 1. Study Flow Diagram
Recruitment and retention in the ABC Study at five years.
Figure 2
Figure 2. IOPs by randomized treatment group and follow-up visit
Graph of IOP (mmHg) in the ABC Study by study group from preoperative level through five year follow-up visit (mean ± SD).
Figure 3
Figure 3. Medication use by randomized treatment group and follow-up visit
Histogram of the number of classes of ocular hypotensive medication used from before surgery through five year follow-up visit (mean ± SD).
Figure 4
Figure 4. Kaplan-Meier cumulative surgical failure rates by randomized treatment group
Kaplan-Meier survival curve of cumulative surgical failures through five years of follow-up by treatment group.
Figure 5
Figure 5. Kaplan-Meier cumulative reoperation rates by randomized treatment group
Kaplan-Meier survival curve of cumulative reoperation rates in through five years of follow-up by treatment group.
See this image and copyright information in PMC

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