New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study

Abstract

Purpose

The XEN gel stent was developed to reduce the risks of filtration surgery by standardizing the outflow of aqueous humor into the subconjunctival space. Recently, a modified version of the XEN63 gel stent was introduced. The goal of this study was to assess its efficacy and safety.

Methods

This is a prospective, nonrandomized, observational, consecutive case series study at a single tertiary centre. Patients with open-angle glaucoma with above target intraocular pressure (IOP) despite maximal tolerated medication were included. The primary outcome was a change of median IOP. Secondary outcomes included a change in the number of medications, complete success, needling and complication rates. Success was defined as a lowering of IOP > 20% from baseline and IOP ≤ 14 mmHg. Complete success indicated that the target IOP was reached without medications.

Results

Six patients were included. The median IOP decreased from 35.5 mmHg (25.0–40.0 mmHg) at baseline to 11.5 mmHg (4.0–15.0 mmHg, p = 0.03), and median IOP-lowering medication was reduced from 4.0 (3.0–4.0) at baseline to 0 (0–1.0, p = 0.03) after two years. Five patients (83.0%) had a complete success after two years. Two patients (33.0%) required a needling procedure. Three patients (50.0%) required an intervention due to symptomatic hypotony within the first three weeks postoperatively. Hypotony resolved completely or was asymptomatic after three months.

Conclusion

Our study demonstrated a statistically significant reduction in both IOP and number of IOP-lowering medications. Complications were well manageable and had no long-term sequelae.

Keywords:

• open-angle glaucoma
• filtering surgery
• minimally invasive surgery
• glaucoma gel stent

Acknowledgments

We acknowledge support from the Open Access Publication Fund of the University of Tübingen.

Disclosure

Dr. Voykov has received speaker honorarium and consultancy fees from AbbVie Deutschland GmbH & Co. KG, Santen GmbH, and Novartis GmbH. All other authors have no relevant financial or non-financial interests to disclose for this work.