Five-year outcomes of ab interno Xen 45 gel stent implantation

Abstract

Background: To assess the safety and 5-year efficacy of ab interno XEN 45 gel stent implantation with phacoemulsification in primary open-angle glaucoma (POAG).

Methods: Single-centre, single-surgeon, retrospective case note review of consecutive OAG patients who underwent ab-interno gel stent placement combined with phacoemulsification. Surgeries were performed between 2/01/2014 and 2/01/2016.

Primary outcome measures: mean reduction in intraocular pressure (IOP) and change in number of ocular hypotensive medications from baseline (follow-up range 1-7 years; mean 54 months).

Secondary outcome measure: change in visual field mean deviation (VFMD) from baseline. Safety data included intraoperative and post-operative complications and adverse events. Failure was defined by IOP reduction < 20% despite maximum medical therapy, the need for further laser or surgical intervention. At 5 years, 75% of eyes were free from failure (95% CI 64 to 83%).

Results: Ninety-one eyes were analysed. Mean (SD) IOP and medications decreased from 20.2 (6.4) mmHg and 2.9 (1.0) at baseline to 15.4 (3.6) mmHg (p < 0.001) and 1.5 (1.4) medications at 5 (p < 0.001) years. Baseline mean VFMD (SD) was - 10.3dB (8.5) reducing to - 10.9(8.2) (p < 0.01) at 5 years. Two (2%) eyes had intraoperative complications, 4 (4.3%) experienced post-operative AEs, and 13 (14%) required secondary surgical intervention (SSI).

Conclusion: The gel stent combined with phacoemulsification was effective in reducing IOP and medications over 5 years, with an acceptable safety profile. Visual field change was clinically acceptable through the study period.

Keywords: Glaucoma; Intraocular pressure (IOP); MIGS; Medication; Visual fields; XEN gel stent.