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Editors Selection IGR 26-1

Surgical Treatment: One-Year Real-World Outcomes of the XEN Gel Stent

Oluwademilade Osawe

Comment by Oluwademilade Osawe & Pouya Alaghband on:

126280 One-Year Real-World Outcomes of Ab-Externo Gel Stent Placement From the EXPAND Study, Francis BA; Vera V; Kim J et al., Journal of Glaucoma, 2025; 34: 330-341


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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.

References

  1. Pirani V, Cavallero E, Cesari C, Virgili F, Ramovecchi V. Ab Externo Transconjunctival XEN® 45 Gel Stent Implantation: Efficacy and Safety of a New Surgical Technique. JOURNAL OF CURRENT GLAUCOMA PRACTICE. 2024 Oct 29 [cited 2025 Aug 18];18(3):94-7. https://doi.org/10.5005/jp-journals-10078-1443
  2. Gagné S, Yuen D, Cohen S. Transconjunctival XEN45 Implantation for Glaucoma Performed at the Slit Lamp: A Pilot Study. Journal of Glaucoma. 2022 Jun 30;18(3). https://doi.org/10.1097/IJG.0000000000002070
  3. Tan NE, Tracer N, Terraciano A, Parikh HA, Panarelli JF, Radcliffe NM. Comparison of Safety and Efficacy Between Ab Interno and Ab Externo Approaches to XEN Gel Stent Placement. Clinical ophthalmology. 2021 Jan 1;Volume 15:299-305. https://doi.org/10.2147/OPTH.S292007
  4. ARSHAM SHEYBANI, VERA V, GROVER DS, VOLD SD, COTTER F, SAHAR BEDROOD, et al. Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months. American journal of ophthalmology. 2023 Aug 1;252:306-25. https://doi.org/10.1016/j.ajo.2023.03.026


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