Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
Leo de Jong1, Antoine Lafuma2, Anne-Sophie Aguadé2, Gilles Berdeaux3,4
1Academic Medical Centre, Ophthalmology Department, Amsterdam, The Netherlands, 2Cemka-Eval, Bourg la Reine, Paris, France, 3Alcon France, Rueil-Malmaison, Paris, France, 4Conservatoire National des Arts et Métiers, Paris, France
Background: This study compared the efficacy of the EX-PRESS® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.
Methods: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.
Results: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.
Conclusion: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.
Keywords: glaucoma filtration device, trabeculectomy, primary open-angle glaucoma, intraocular pressure, medication
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