Two-year outcomes of Xen 45 gel stent implantation in patients with open-angle glaucoma: real-world data from the Fight Glaucoma Blindness registry.
Arnould Louis, Balsat Elise, Hashimoto Yohei, White Andrew, Kong George, Dunn Hamish, Fan Leo, Gabrielle Pierre-Henry, Bron Alain M, Creuzot-Garcher Catherine P
AI Summary
This study found the Xen 45 gel stent effectively lowers IOP in open-angle glaucoma over two years, but often requires reoperations, especially when combined with cataract surgery.
Abstract
Objective
To evaluate efficacy and safety outcomes of the Xen 45 gel stent implant over 24 months of follow-up.
Methods
A retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry. Complete success (CS) was defined as intraocular pressure (IOP) reduction ≥20% from preoperative and an IOP ≤18 mm Hg and ≥6 mm Hg with no secondary procedure at 2 years and without IOP-lowering medications. Qualified success (QS) was defined similarly, allowing the use of IOP-lowering medications.
Results
The Xen 45 gel stent implant was implanted in 646 eyes of 515 patients. Preoperative IOP was 21.4±7.6 (mean±SD) mm Hg on 2.7±1.3 IOP-lowering medication and mean deviation was -10.2±8.4 dB. After 24-month follow-up, IOP was 16.8±7.3 mm Hg (mean reduction of 21.7%) on 1.2±1.4 IOP-lowering medications. CS and QS rates at 24 months were 26% and 48%, respectively. CS and QS were higher in the Xen stand-alone group (33% and 52%, respectively) than in the Xen+cataract group (16% and 42%, respectively). Bleb needling was performed in 28.4% of cases, and 18% underwent a secondary procedure.
Conclusions
The Xen 45 gel stent implant offers acceptable long-term efficacy for the treatment of open-angle glaucoma. However, there is a significant rate of reoperation and needling, and outcomes are less effective if combined with cataract surgery.
MeSH Terms
Shields Classification
Key Concepts5
In a retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry, the Xen 45 gel stent implant in 646 eyes of 515 patients achieved a mean intraocular pressure (IOP) reduction of 21.7% (from 21.4±7.6 mm Hg preoperatively to 16.8±7.3 mm Hg) at 24 months of follow-up, with a reduction in IOP-lowering medications from 2.7±1.3 to 1.2±1.4.
In a retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry, the Xen 45 gel stent implant in 646 eyes of 515 patients showed complete success (IOP reduction ≥20% from preoperative, IOP ≤18 mm Hg and ≥6 mm Hg, no secondary procedure, no IOP-lowering medications) and qualified success (similar, but allowing IOP-lowering medications) rates at 24 months of 26% and 48%, respectively.
In a retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry, complete success (CS) and qualified success (QS) rates for the Xen 45 gel stent implant were higher in the Xen stand-alone group (33% CS and 52% QS) than in the Xen+cataract group (16% CS and 42% QS) at 24 months of follow-up.
In a retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry, bleb needling was performed in 28.4% of cases and 18% underwent a secondary procedure after Xen 45 gel stent implantation in 646 eyes of 515 patients over 24 months of follow-up.
A retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry on 646 eyes of 515 patients evaluated the efficacy and safety outcomes of the Xen 45 gel stent implant over 24 months of follow-up.
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