Early Clinical Results of a Novel Ab Interno Gel Stent for the Surgical Treatment of Open-angle Glaucoma

Abstract

To evaluate the intraocular pressure (IOP) lowering effect of the XEN140 microfistula gel stent implant for the surgical treatment of open-angle glaucoma. Forty-nine eyes of 49 patients with an IOP>18 mm Hg and ≤35 mm Hg were studied in a prospective nonrandomized multicenter cohort trial of the surgical implantation of the XEN140 implant in patients with open-angle glaucoma. Complete success was defined as a postoperative IOP≤18 mm Hg with ≥20% reduction in IOP at 12 months without any glaucoma medications. Failure was defined as vision loss of light perceptions vision or worse, need for additional glaucoma surgery, or <20% reduction of IOP from baseline. The average age was 64.3 (28.1 to 86.9) years old. Twenty-one eyes had prior failed trabeculectomy with mitomycin C surgery. IOP at 12 months decreased from a mean of 23.1 (±4.1) mm Hg to 14.7 (±3.7) mm Hg for a 36.4% reduction in IOP from baseline. The number of patients at 12 months who achieved an IOP≤18 mm Hg and ≥20% reduction in IOP was 40 (89%). The number of patients who achieved an IOP≤18 mm Hg and ≥20% reduction in IOP without antiglaucoma medications was 18 (40%). The XEN140 gel stent lowers IOP with few complications when implanted for the surgical treatment of open-angle glaucoma.