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Objective
To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma.
Design
International, multicenter, randomized trial.
Participants
Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy.
Methods
Eligible patients were randomized to 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 of the target range (5-18 mmHg, with ¡Ý20 % reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions.
Results
A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37 % had previously failed trabeculectomy. The mean preoperative IOP was 31.4¡À10.8 mmHg on 3.1¡À1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51 % in the Ahmed group and 34 % in the Baerveldt group (P?= 0.03). Mean IOP was 15.7¡À4.8 mmHg in the Ahmed group (49 % reduction) and 14.4¡À5.1 mmHg in the Baerveldt group (55 % reduction; P?= 0.09). Mean number of glaucoma medications was 1.8¡À1.4 in the Ahmed group (42 % reduction) and 1.1¡À1.3 in the Baerveldt group (65 % reduction; P?= 0.002). There was a moderate but similar decrease in visual acuity in both groups (P?<?0.001). The 2 groups had similar complication rates (52 % Ahmed, 62 % Baerveldt; P?= 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0 % Ahmed, 6 % Baerveldt; P?= 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38 % Ahmed, 50 % Baerveldt; P?= 0.07). Most complications were transient, and most interventions were slit-lamp procedures.
Conclusions
Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications.
Financial Disclosure(s)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
