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See also comment(s) by Tec Kuan Paul Chew & Victor Koh •
PURPOSE: To determine the relative efficacy of the Ahmed-FP7 and Baerveldt BG101-350 implants. DESIGN: Pooled analysis of two multicenter, randomized, clinical trials. METHODS: 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 6-18 mmHg inclusive), de novo glaucoma surgery rates, mean IOP, mean glaucoma medication use, and visual acuity were compared. RESULTS: Baseline characteristics were similar between groups. Mean preoperative IOP of the study population was 31.5±11.3 mmHg on an average of 3.3±1.1 glaucoma medications. At 5-years, mean IOP was 15.8±5.2 mmHg in the Ahmed group and 13.2±4.7 mmHg in the Baerveldt group (p<0.001). Mean glaucoma medication use was 1.9±1.5 in the Ahmed group and 1.5±1.4 in the Baerveldt group (p=0.007). The cumulative failure rate at 5-years was 49% in the Ahmed group and 37% in the Baerveldt group (p=0.007). 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=0.006). Failure due to hypotony occurred in 0.4% of the Ahmed group and 4.5% of the Baerveldt group (p=0.002). Visual outcomes were similar between groups (p=0.90). CONCLUSIONS: The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and had a lower mean IOP on fewer medications than the Ahmed group. Baerveldt implantation carried a higher risk of hypotony.
Department of Ophthalmology and Vision Sciences, University of Toronto Faculty of Medicine, Toronto, Canada.
Full article12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)