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Panos G. Christakis, David Zurakowski, James C. Tsai, Jeffrey W. Kalenak, Jeffrey A. Kammer, Louis B. Cantor, Paul J. Harasymowycz, Ike K. Ahmed; The Ahmed Versus Baerveldt (AVB) Study: 2 Year Results. Invest. Ophthalmol. Vis. Sci. 2011;52(14):2626.
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To report 2-year results of the Ahmed versus Baerveldt (AVB) Study: a multicenter randomized clinical trial comparing the two most frequently implanted aqueous drainage devices.
Patients were recruited from 7 international sites by 10 surgeons. Inclusion criteria required patients be 18+ years old with uncontrolled glaucoma refractory to medical, laser and surgical therapy. Eligible patients were randomized to receive either an Ahmed-FP7 valve (AGV) or a Baerveldt-350 implant (BGI) using standardized surgical technique. Outcome measures included intraocular pressure (IOP), visual acuity (VA), glaucoma medication use, complications and treatments. The IOP goal was 5mmHg-18mmHg inclusive with a reduction >=20% from baseline. Failure was defined as two consecutive visits from 3 months onwards in which the IOP goal was not met, additional glaucoma surgery, devastating complications, or loss of light perception.
238 patients were enrolled, including 124 in the AGV group and 114 in the BGI group. There were no significant differences in baseline characteristics between the two groups. Prior to surgery, the study group had a mean IOP (±SD) of 31.4±10.8 mmHg on a mean of 3.1±1.0 glaucoma medications with a median Snellen VA of 20/100. At 2-years, mean IOP was 16.1±6.4 mmHg in the AGV group and 14.5±6.6 mmHg in the BGI group (p=0.12). Mean number of glaucoma medications required was 1.8±1.4 in the AGV group and 1.0±1.2 in the BGI group (p<0.001). Median Snellen VA was 20/150 in both groups (p=0.99). Complications occurred in 61(49%) AGV patients and 69(61%) BGI patients (p=0.08). Treatments were required in 40(32%) AGV patients and 54(47%) BGI patients (p=0.02). The cumulative probability of failure was 48% in the AGV group and 31% in the BGI group (p=0.02).
At 2-years, the BGI group had a lower cumulative probability of failure and required a fewer mean number of glaucoma medications than the AGV group. However, more treatments were required in the BGI group. The two groups had comparable VAs, mean IOPs and experienced a similar number of complications.
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