XEN-45 GEL IMPLANT: 2-YEAR OUTCOMES

 

A retrospective analysis of the prospectively collected data from the Fight Glaucoma Blindness observational registry was used to evaluate the real-world efficacy and safety outcomes of the Xen-45 gel stent implant over 24 months of follow-up.

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Xen 45 was implanted in 646 eyes of 515 patients. [Xen stand-alone (n=199) and Xen+cataract (n=139)]

The most common diagnosis was primary open-angle glaucoma accounting for 69% of cases. Preoperatively, the mean IOP was 21.4±7.6mm Hg, the mean number of medications was 2.7±1.3 and the average visual field mean deviation where that was recorded, was −10.2±8.4dB.

Sub-group analysis included Xen implant alone versus Xen+Cataract surgery.

Complete success (CS) was defined as intraocular pressure (IOP) reduction ≥20% from preoperative and an IOP ≤18mm Hg and ≥6mm 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.

Preoperative IOP was 21.4±7.6 (mean±SD) mm Hg on 2.7±1.3 IOP-lowering medication and the mean deviation was −10.2±8.4 dB.

After 24-month follow-up, IOP was 16.8±7.3mm Hg (mean reduction of 21.7%) on 1.2±1.4 IOP-lowering medications, a mean reduction of 1.6 medications. The proportion of eyes which were completely off all glaucoma medications was 51%.

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).

Success rates of 27% and 34% after Xen gel implant have been reported in other studies.

Bleb needling was performed in 28.4% of cases. Some other studies have reported rates of bleb needling following Xen implantation ranging from 41% to 62%.

18% of patients underwent a secondary glaucoma procedure, most commonly being bleb revision (7.5%). This included either bleb revision alone or revision combined with cataract surgery. In addition, 5.1% of eyes underwent trabeculectomy following Xen implantation within the first 24 months.

The most common adverse event was a loss of ≥10 letters of VA from baseline. This occurred in 31% of eyes within the first 6 months after surgery. This was attributed to ocular hypotony. Device exposure occurred in 1.8% eyes.

CONCLUSION:

The Xen 45 gel stent implant offers acceptable long-term efficacy for treating open-angle glaucoma. However, there is a significant rate of reoperation and needling, and outcomes are less effective if combined with cataract surgery.

REFERENCE:

Arnould L, Balsat E, Hashimoto Y, et al. Br J Ophthalmol Epub ahead of print: [please include Day Month Year]. doi:10.1136/ bjo-2023-325077.