Five-Year Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study

Abstract

To determine the relative efficacy of the Ahmed-FP7 and Baerveldt BG101-350 implants. Pooled analysis of 2 multicenter, randomized clinical trials. A total of 514 patients aged 18 or older with uncontrolled glaucoma that had failed or were at high risk of failing trabeculectomy were randomized to receive an Ahmed implant (n= 267) or Baerveldt implant (n= 247). Cumulative failure rates (using an intraocular pressure [IOP] target of 6-18mm Hg inclusive), de novo glaucoma surgery rates, mean IOP, mean glaucoma medication use, and visual acuity were compared. Baseline characteristics were similar between groups. Mean preoperative IOP of the study population was 31.5 ± 11.3mm Hg on an average of 3.3 ± 1.1 glaucoma medications. At 5 years, mean IOP was 15.8 ± 5.2mm Hg in the Ahmed group and 13.2 ± 4.7mm Hg in the Baerveldt group (P < .001). Mean glaucoma medication use was 1.9 ± 1.5 in the Ahmed group and 1.5 ± 1.4 in the Baerveldt group (P= .007). The cumulative failure rate at 5 years was 49% in the Ahmed group and 37% in the Baerveldt group (P= .007). High IOP was the most common reason for failure in both groups, and de novo glaucoma surgery was required in 16% of the Ahmed group and 8% of the Baerveldt group (P= .006). Failure owing to hypotony occurred in 0.4% of the Ahmed group and 4.5% of the Baerveldt group (P= .002). Visual outcomes were similar between groups (P= .90). The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and lower mean IOP on fewer medications than the Ahmed group. Baerveldt implantation carried a higher risk of hypotony.