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Real-world initial results of the XEN® 45 Gel Stent in the Brazilian population

ABSTRACT

Objective

To evaluate the preliminary medium-term results (up to 6 months) of the stand-alone use of XEN® Gel Stent implantation or in combination with cataract surgery in the Brazilian population.

Methods

A retrospective longitudinal study was carried out on eyes with primary open-angle glaucoma consecutively submitted to XEN® Gel Stent implantation surgery alone (XEN® Group) or in combination with cataract surgery (Phaco-XEN® Group) in the same center between April and December 2023. The ability to reduce intraocular pressure and the amount of ocular hypotensive medications were analyzed, in addition to intra- and postoperative complications. The success criterion was intraocular pressure < 18 mmHg and at least 20% reduction from the preoperative intraocular pressure (absolute success: without medication; relative success: with or without medication). The duration of the surgical procedure was also evaluated throughout the learning curve.

Results

Thirty-seven eyes were included in the study (15 in the Phaco-XEN® group and 22 in the XEN® group). The mean intraocular pressure was reduced from 19.35 mmHg preoperatively to 13.05 mmHg at the end of the follow-up (p < 0,001). The amount of medication decreased from 2.95 to 0.22 per eye in the same period (p < 0,001). Of the patients, 83% reached the end of follow-up without no need for eye drops. There were no differences between the two groups in terms of intraocular pressure reduction capacity and eye drops. The absolute success rate was 81.2 and 86.7% in the XEN® and Phaco-XEN® Groups, respectively (p = 0.532). Six eyes presented bleb failure and required surgical reintervention. There was a significant reduction in surgery time throughout follow-up.

Conclusion

The XEN® gel stent implantation was effective, both in stand-alone and in combined surgery, in reducing intraocular pressure and the medication burden, with a high safety profile in the Brazilian population.

Glaucoma, open-angle; Medications

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