Real-World Safety And Efficacy Of Combined Phacoemulsification And Xen45 Gel Stent Implantation In Open-Angle Glaucoma

To evaluate the real-world efficacy, medication-sparing effect, and safety of combined phacoemulsification and XEN45 Gel Stent implantation in eyes with open-angle glaucoma undergoing cataract surgery.

The study was carried out at the Department of Ophthalmology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France, a tertiary care center managing patients with glaucoma and cataract in routine clinical practice. Combined phacoemulsification and XEN45 Gel Stent implantation was performed as part of standard surgical care in patients with medically treated open-angle glaucoma requiring cataract surgery.

This retrospective single-center study included 25 eyes of 15 patients who underwent combined phacoemulsification and XEN45 implantation. Collected variables included intraocular pressure (IOP), number of glaucoma medication classes, visual acuity, and postoperative adverse events. IOP was assessed preoperatively and at 1, 3, 6, and 12 months. Surgical success was defined as complete success when IOP was <18 mmHg without medication and qualified success when IOP was <18 mmHg with or without medication. Continuous variables are reported as mean ± standard deviation. Paired comparisons were performed on available follow-up data.

Mean preoperative IOP was 17.8±5.7 mmHg on 3.12±0.88 medication classes. Postoperative mean IOP was 12.0±3.5 mmHg at 1 month, 13.9±5.4 mmHg at 3 months, 16.8±2.6 mmHg at 6 months, and 15.2±2.7 mmHg at 12 months. Compared with paired preoperative values, IOP reduction was significant at 1 month (p=0.0013) and 12 months (p=0.0156). Mean medication burden decreased to 0.76 at 6 months and 1.11 at 12 months. Complete success was achieved in 48.0% of eyes and qualified success in 80.0%. Needling with 5-FU was required in 28.0% of eyes. Postoperative complications included transient athalamia (12.0%), hyphema (8.0%), and tube extrusion (4.0%), with no endophthalmitis or choroidal detachment.

In a real-world setting, combined phacoemulsification and XEN45 implantation provided significant pressure lowering, marked medication reduction, and acceptable safety in eyes with open-angle glaucoma. This combined approach represents a relevant minimally invasive option for glaucomatous patients requiring cataract surgery, especially when reducing treatment burden is a key goal. Further prospective studies with longer follow-up are warranted.