[XEN Gel Stent: Long-term safety and efficacy in glaucoma surgery - a single-center retrospective study].

OBJECTIVE

The efficacy and safety evaluation of XEN® gel stent implantation, alone and combined with cataract surgery, in glaucoma's surgical treatment, at short- and long-term.

MATERIAL AND METHOD: In this single-center retrospective study, all patients who received a XEN® gel stent between September 2018 and October 2023 were included. The primary outcome was complete success rate (≥20% decrease in IOP without medication or complication) and qualified success rate (with antiglaucoma treatment or minimal complication) at 1month, 6months, 1year, 2years, 3years and 5years. Needlings were not considered as failures. Secondary endpoints included number of postoperative medications, failures, complications, needlings, visual acuity, RNFL OCT and visual field.

RESULTS

One hundred and one eyes of 83 patients were analyzed (41 XEN® single, 60 combined with cataract surgery). Complete success rate went from 73.3% at 1month to 33.3% at 5years, and mean IOP from 17.98mmHg to 13.68mmHg at 5years, with a reduction of around 22% (±4.98). Antiglaucoma medications decreased significantly at all times, from 3 (±0.989 95% CI [0.870-1.149]) classes before surgery to 1 (±1.328 95% CI [0.997-1.991]) class at 5years. Needling was needed in 38.9% cases. Among the 22 failures, ten eyes required trabeculectomy to control IOP, and one case of endophthalmitis was noted.

CONCLUSION

XEN®, alone or in combination, provides effective, long-lasting IOP and medication reduction up to 5years, with a good safety profile, in glaucoma's treatment. However, needling is often necessary, and efficacy seems to decrease over time, so, a close postoperative follow-up is required.