One year results of the XEN45 Gel Stent in a multicenter Italian cohort

Abstract

Purpose : The Xen45 Gel Stent is a minimally invasive glaucoma surgery (MIGS) device that creates a shunt between the anterior chamber and the subconjunctival space, resulting in a subconjunctival filtering bleb.
Aim of this study was to evaluate the efficacy and safety of this new MIGS device in 5 Italian centers through one year

Methods : Patients with uncontrolled primary open angle glaucoma on maximally tolerated medical therapy underwent stent implantation (SOLO) or stent implantation combined with cataract surgery (COMBO) as deemed necessary. Closed angle glaucoma or previous ocular surgery was the main exclusion criterion. Intraocular pressure (IOP) and number of glaucoma medications were evaluated at baseline and follow-up. Intra-operative and post-operative complications were recorded.

Results : 75 consecutive eyes were included in the SOLO group and 20 in the COMBO group. Mean pre-operative IOP and pre-operative topical medications were 26.8±7.95 mmHg and 3.2±0.9 in the SOLO group and 23.5±3.99 mmHg and 3.1±1.5 in the COMBO group. 15 patients were on acetazolamide in the SOLO group and 3 in the COMBO group. In the SOLO group mean IOP at 6 and 12 months was 15.7±5 and 14.9±2.5 mmHg; in the COMBO it was 14.7±1.2 and 14.8±2.6 mmHg. At one year the average number of medication in the SOLO and COMBO group was 0.4±0.8 and 1.1±1.5 respectively. No patient was on systemic medications at the end of the follow-up. The decrease in IOP and number of medications was significant (p<0.01) in both groups. No significant differences were observed between groups. 7 patients presented with a hyphema less than 1 mm that resolved in the first postoperative week. IOP was ≤6 mmHg in 11 eyes of the SOLO and in 5 in the COMBO group.
Needling rate ranged between 20 and 60% in the 5 centers.

Conclusions : The XEN45 stent provides a significant decrease in IOP and in the number of glaucoma medications and shows a good safety profile.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.