The Ahmed Versus Baerveldt Study Five-Year Treatment Outcomes

Purpose: To compare 2 frequently used aqueous shunts for the treatment of glaucoma. Design: International, multicenter, randomized trial. Participants: Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. Methods: Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. Main Outcome Measures: The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. Results: A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4 +/- 10.8 mmHg on 3.1 +/- 1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6 +/- 5.9 mmHg in the Ahmed group (47% reduction) and 13.6 +/- 5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8 +/- 1.5 mmHg in the Ahmed group (44% reduction) and 1.2 +/- 1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. Conclusions: Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group. (C) 2016 by the American Academy of Ophthalmology.