Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap.

PURPOSE: To evaluate the Ex-PRESS miniature implant (Model R 50) placed under partial-thickness scleral flap compared with standard trabeculectomy.

METHODS: In this retrospective comparative series of 100 eyes, we compared 50 eyes in 49 patients treated with the Ex-PRESS miniature glaucoma implant under a scleral flap with 50 matched control eyes in 47 patients treated with trabeculectomy. Success was defined as intraocular pressure (IOP) > or =5 mm Hg and < or =21 mm Hg, with or without glaucoma medications, without further glaucoma surgery or removal of implant. Early postoperative hypotony was defined as IOP <5 mm Hg during the first postoperative week.

RESULTS: The average follow-up was 10.8 months (range 3.5 to 18) for the Ex-PRESS group and 11.2 months (range 3 to 15) for the trabeculectomy group. Although the mean IOP was significantly higher in the early postoperative period in the Ex-PRESS group compared with the trabeculectomy group, the reduction of IOP was similar in both groups after 3 months. The number of postoperative glaucoma medications in both groups was not significantly different. Kaplan-Meier survival curve analysis showed no significant difference in success between the 2 groups (P=0.594). Early postoperative hypotony and choroidal effusion were significantly more frequent after trabeculectomy compared with Ex-PRESS implant under scleral flap (P<0.001).

CONCLUSIONS: The Ex-PRESS implant under a scleral flap had similar IOP-lowering efficacy with a lower rate of early hypotony compared with trabeculectomy.