This study investigated the efficacy and safety of a cross-linked collagen stent (XEN 45) with or without cataract surgery in the treatment of glaucoma.
Real-life setting.
Prospective, open-label, multicenter clinical trial.
Eligible patients with glaucoma inadequately controlled by treatment, or poor compliance or intolerance to topical therapy were included. Patients were divided into those with implant only (solo group; phakic and pseudophakic patients) and implant combined with cataract surgery (combo group). Differences in average intraocular pressure (IOP) and number of medications between baseline and study end (12 months), and the rate of qualified and complete success were evaluated.
Overall, there were 115 patients in the solo group (43 phakic and 72 pseudophakic) and 56 in the combo group. 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 study end (P < 0.001 for both). A >20% and >30% reduction in IOP from baseline was achieved by 72.3% and 52.6% of patients, respectively. IOP at one week post-op was a predictor of success, and the needling rate was inversely correlated to early post-op IOP. The number of pre-operative medications and patientage were not significantly associated with failure.
Insertion of the XEN 45 stent alone or combined with phacoemulsification is effective and safe in the treatment of open angle glaucoma, with a substantial reduction in IOP and number of medications. Future randomized, comparative studies on the use of this device are warranted.