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Fourth year follow up results after transscleral XEN glaucoma gel stent implantation in a prospective multicenter trial

Poster Details

First Author: M.Lenzhofer AUSTRIA

Co Author(s):    I. Kersten-Gomez   A. Sheybani   C. Strohmaier   M. Hohensinn   H. Reitsamer  

Abstract Details

Purpose:

The transscleral XEN glaucoma gel stent is a minimally invasive ab interno implanted glaucoma stent (AqueSys Inc., CA, USA). The implant creates a fistula between anterior chamber and subconjunctival space. Since its introduction, the implant has been changed. Some of the early XEN glaucoma gel models have been followed up more than 4 years. The present study therefore aimed to assess the long time clinical outcomes in POAG patients after XEN glaucoma gel stent implantation.

Setting:

In this prospective, non-randomized, multi-center evaluation conducted in 3 countries (Austria, Canada, and Germany), 66 eyes were implanted with the XEN glaucoma gel stent, whereby 39 eyes reached the 4 years follow up. Department of Ophthalmology, University Clinic Bochum, Germany Credit Valley EyeCare, Mississauga, Ontario, Canada Department of Ophthalmology and Optometry, Paracelsus Medical University, Austria

Methods:

During surgery, a trans-scleral gelatin stent is placed through a self-sealing corneal incision using a preloaded injector. All patients had mild or moderate OAG, 51% were solo procedures, and 49% were combined with cataract surgery. This data set incorporates 2 inner lumen sizes of the same gel stent (140µm and 63µm). Mean IOP, IOP change, reduction in medications and mean deviation of visual field were analyzed.

Results:

Mean best-medicated baseline IOP was 22.3 ±4.1mmHg and decreased significantly to 13.5 ±3.0mmHg 4 years postoperative (n=39, p < 0.001), what corresponds to a -39% reduction of IOP. Mean number of IOP lowering medication decreased significantly from 2.5 ±1.3 preoperative to 1.1 ±1.3 (-56%, p < 0.001) postoperative (n=39). Visual field mean deviation showed no significant change between preoperative and postoperative examinations. 11/66 patients (17%) were lost of follow up and 16/66 patients (24%) had to be excluded from 4 year analysis because of secondary IOP lowering procedures (1 SLT, 12 filtering surgeries, and 3 cyclodestructive procedures).

Conclusions:

Long term efficacy shows good IOP reduction (-39%) and decrease of IOL lowering Meds (-56%) after XEN glaucoma gel stent implantation. Visual function regarding the visual fields was stable. Success rate is comparable to other filtration surgeries using implants (6% failure rate/a). The XEN Gel Microstent shows good long term efficacy. Minimal invasiveness and its excellent safety profile make it a promising option for glaucoma surgery especially in early as well as in late stages of the disease. FINANCIAL DISCLOUSRE: One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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