Posters

XEN 63 gel stent device in glaucoma surgery: a five-year follow-up prospective study

Poster Details

First Author: C.Lavin-Dapena SPAIN

Co Author(s):                        

Abstract Details

Purpose:

To evaluate the efficacy and safety of the XEN63 Gel Stent in patients with open-angle glaucoma (OAG).

Setting:

Prospective, nonrandomized, open-label, not-controlled and single center study.

Methods:

Eleven OAG patients were assigned to undergo glaucoma surgery (XEN63 Gel Stent). The procedure was performed in all the cases without mitomycin-C. Intent-to-treat (ITT) efficacy analyses included all patients who underwent XEN63 surgery and had at least a valid month 6 visit. Per protocol (PP) analyses excluded patients who did not complete the study (month 60 visit) or who had major protocol violations. The primary end-point was the intraocular pressure (IOP) at the end of the follow-up period.

Results:

ITT population, mean IOP reduction from baseline was -4.0 (-9.2 to 1.2) mm Hg, p=0.2212 In the PP population, mean IOP reduction from baseline was -7.0 (-14.3 to 0.3) mm Hg, p=0. 0465.  9 (81.8%) eyes had an IOP ≤ 18 mm Hg, 6 of them without treatment. Additionally, 6 (54.6%) eyes obtained an IOP reduction ≥ 20%. As compared to baseline, the number of pharmacological active principles was significantly reduced in both ITT (p=0.0039) and PP (p=0.0010) populations. There were no serious complications related to the treatment. Only one eye, required needling, that was performed with 5-fluorouracilo week 2

Conclusions:

XEN63 implant can be successfully used to reduce both IOP and the number of antiglaucoma medications, with a good safety profile.

Financial Disclosure:

None