4th year long-term follow-up results after minimally invasive transscleral XEN glaucoma gel stent ab interno implantation in a prospective multicenter trial

Session Details

Session Title: Glaucoma I

Session Date/Time: Sunday 11/09/2016 | 14:30-16:00

Paper Time: 15:18

Venue: Auditorium C6

First Author: : I.Kersten-Gomez GERMANY

Co Author(s): :    M. Lenzhofer   L. Eisenkopf   I. Ahmed   H. Reitsamer   B. Dick        

Abstract Details

Purpose:

The transscleral XEN glaucoma gel stent is a minimally invasive ab interno implanted glaucoma stent (formerly AqueSys Inc., CA, USA, now Allergan, CA, USA) with subconjunctival drainage. Some of the early XEN glaucoma gel models have been followed up more than 4 years in 3 countries. The present study therefore aimed to assess the long-term clinical outcomes in POAG patients after XEN glaucoma gel stent implantation.

Setting:

This prospective, non-randomized, multicenter evaluation was performed in three countries: at the University Eye Hospitals of Salzburg, Austria and Toronto, Canada and Bochum, Germany.

Methods:

In this prospective, non-randomized, multicenter evaluation conducted in 3 countries, 66 eyes were implanted with the XEN glaucoma gel stent, whereby 39 eyes reached the 4 year follow up. 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 (140 µm and 63 µm). Mean IOP, IOP change (in %), reduction in medications and mean deviation of visual fields were analyzed.

Results:

Best-medicated baseline IOP was 22.3 ± 4.1 mmHg and decreased significantly to 13.5 ± 3.0 mmHg 4 years postoperatively (n=39, p < 0.001), which corresponds to a -39% reduction of IOP in long-term follow up. Mean number of IOP lowering medication decreased significantly from 2.5 ±1.3 preoperatively to 1.1 ±1.3 (-56%, p < 0.001) postoperatively (n=39). Visual field mean deviation showed no significant change. 11/66 patients (17%) were lost to 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 IOP lowering medication (-56%) after XEN gel stent implantation. Visual fields were stable. Success rate is comparable to other filtration surgeries using implants (6% failure rate/a). Minimal invasiveness, its safety profile and long-term efficacy make it a reasonable option as an additional method for surgical glaucoma therapy, sparing the conjunctiva and not blocking further filtration surgery.

Financial Disclosure:

... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented