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The XEN gel glaucoma stent is a microinvasive bleb-forming procedure (MIBS) traditionally implanted ab-interno but increasingly adapted to an ab-externo technique. This retrospective, multicentre study evaluated one-year outcomes of ab-externo XEN implantation across 19 sites in the United States, including 466 eyes without prior bypass surgery undergoing either stand-alone implantation or combined with phacoemulsification surgery.
The primary endpoint was a ≥20% IOP reduction from baseline without clinical hypotony, vision loss to counting fingers, secondary glaucoma surgery, or increased medication. At one year, 39.1% of all eyes achieved this endpoint, rising to 54.9% among those with complete IOP and medication data (n=213). Mean IOP decreased from 22.4mmHg on 2.8 medications at baseline to 14.8mmHg on 1.1 medications.
Safety outcomes were acceptable: postoperative complications occurred in 36.7%, most commonly self-resolving hypotony and uncontrolled IOP requiring further surgery. Needling was required in 28.6%, largely within the first three months.
These findings support the ab-externo approach as an effective method of lowering IOP and reducing medication dependency, consistent with prior smaller studies(1-3).
Nevertheless, several limitations must be acknowledged. The retrospective, non-randomised design and high attrition rate (only 56.2% completed one-year data), introduce potential bias. Non-standardisation of surgical technique also affects outcomes and limits interpretability. Inclusion of both stand-alone XEN implantation and combined procedures further complicates interpretation, while the predominance of white Caucasian patients (60.8%) reduces generalisability to more diverse population.
Biological plausibility is sound, as aqueous drainage via bleb formation is well established and familiar to glaucoma surgeons. However, compared with similar ab-interno studies, success rates appear lower, likely reflecting surgeon learning curves, variability in technique, and a cohort with more advanced disease(4).
In summary, this study provides real-world evidence for ab-externo XEN implantation. However, further prospective studies with standardised protocols are required to confirm efficacy, safety, and long-term benefits.