European study of the efficacy of a cross-linked gel stent for the treatment of glaucoma

PURPOSE: To investigate the efficacy and safety of a cross-linked gel stent (XEN45) with or without cataract surgery in the treatment of glaucoma patients. SETTING: Five university hospitals. DESIGN: Prospective multicenter clinical trial. METHODS: Patients with glaucoma inadequately controlled by treatment or poor compliance or intolerance to topical therapy were included. Patients were divided into those who had an implant only (Solo Group; phakic and pseudophakic patients) and those who had an implant combined with cataract surgery (Combo Group). Differences in mean intraocular pressure (IOP) and number of medications between the baseline preoperative visit and study end (12 months), and the rate of qualified and complete success, were evaluated. RESULTS: The Solo Group comprised 115 glaucoma patients (43 phakic and 72 pseudophakic) and the Combo Group comprised 56 patients. Compared with baseline, mean IOP (23.9 ± 7.6 to 15.5 ± 3.9) and number of medications (3.0 ± 1.1 to 0.5 ± 1.0) decreased significantly at 12-month follow-up (P < .001 for both). A >20% and >30% reduction in IOP from baseline was achieved by 72.3% and 52.6% of patients, respectively. IOP at 1 week postoperatively was a predictor of success, and the needling rate was inversely correlated with early postoperative IOP. The number of preoperative medications and patient age were not significantly associated with failure. CONCLUSIONS: Insertion of a cross-linked gel stent alone or combined with phacoemulsification might be effective and safe in the treatment of open-angle glaucoma, with a substantial reduction in IOP and number of medications.