XEN ® Gel Implant for Glaucoma; Prospective Cohort Study in a High-Volume Department

Purpose: To evaluate the 3-year efficiency and safety of XEN® 45 gel stent implantation in a heterogenous group of open angle glaucoma patients. Methods: In this prospective, non-randomized observational study we identified patients who had undergone either stand-alone XEN® implantation (XEN solo) or XEN® implantation in combination with phacoemulsification (XEN combi). All patients who had undergone an implantation during the period 01.04.17-31.10.19 at the Department of Ophthalmology, Drammen Hospital, Norway, were asked to participate. Success was defined as IOP between 5 - 18 mmHg and 20% pressure reduction without medications. Qualified success required the same pressure interval and reduction but allowed medications. The procedure was deemed as failure if pressure requirements were not met, vision was reduced to light perception or worse, or if there was a converion to secondary glaucoma surgery. Results: Out of 115 patients and 133 eyes identified, 87 patients and 99 eyes consented to participate. All patients were Caucasians with a mean age of 73.6 years. The study had a mean (range) follow-up of 38.9 (28 - 54) months. The mean medicated baseline (SD) was reduced from 22.6 (7.9) mmHg on 3.2 (1.1) medications to 14.2 (5.6) mmHg on 1.4 (1.6) medications. Success and qualified success were achieved in 22.2% and 21.2%, respectively. Needling was performed in 34 eyes. Conclusion: XEN® 45 gel stent implantation is a safe procedure, offering a significantly lower IOP and number of medications in a subset of patients with open angle glaucoma.