Two-year clinical results of XEN45® gel stent in a tertiary centre of ophthalmology in Portugal

Session Details

Session Title: Presented Poster Session: Glaucoma II

Venue: Poster Village: Pod 3

First Author: : N.Moura-Coelho PORTUGAL

Co Author(s): :    E. Luís   M. Vieira   J. Cardigos   M. Dutra-Medeiros   T. Gomes   M. Reina        

Abstract Details

Purpose:

To analyze the 2-year clinical efficacy and safety profile of the XEN45® Gel Stent Glaucoma Treatment System (Allergan, Irvine, CA) for the treatment of medically refractory open-angle glaucoma (mr-OAG).

Setting:

Tertiary Center of Ophthalmology in Portugal, reporting the initial experience with the XEN stent nationwide.

Methods:

Retrospective study of all patients who had XEN implanted at our institution with post-operative follow-up≥24months. Data analysed: type of glaucoma; intra-ocular pressure(IOP,mmHg) pre-XEN, at 1st post-operative day(D1), 1st month(M1), 6 months(M6), 1 year(M12), 18 months(M18) and 2 years(M24); number of IOP-lowering drugs pre-XEN,at M6,M12,M24; type of surgery; intra/post-operative complications; need for needling; need for other glaucoma surgery. Primary endpoint: surgical success, defined as absolute IOP≤18mmHg and/or reduction rate(IOP-RR)≥20% from baseline at M24, either with(relative success) or without(absolute success) IOP-lowering drugs. Secondary endpoints: reduction in number of IOP-lowering drugs at M24; needling rate; need for other glaucoma surgery.

Results:

18 eyes were analyzed (66.6% primary OAG). Twelve eyes had standalone XEN implantation, the remaining had combined XEN/cataract surgery. Mean baseline-IOP was 21.2(4.9)mmHg [median number of IOP-lowering drugs=4(1)]. At M24, mean IOP reduction was 5.94(6.49)mmHg.  Reduction in mean/median IOP was statistically significant at all timepoints(D1 p<0.001;M1 p=0.031;M6 p=0.013;M12 p=0.001;M18 p=0.007;M24 p=0.002); reduction in median number of IOP-lowering drugs was also statistically significant(p<0.001). Surgical success was achieved in 77.8% of eyes, half of which were absolute success. Needling rate was 27.8%. Two eyes required bleb revision, and 1 eye(5.6%) needed other glaucoma surgery for uncontrolled IOP.

Conclusions:

In our study, XEN stent implantation showed good efficacy for lowering IOP in eyes with mr-OAG at 2-year follow-up, leading to a significant reduction in IOP and in need of IOP-lowering drugs with a reasonable safety profile. Of note, XEN stent implantation may delay need for more invasive glaucoma surgery. Larger, prospective studies are encouraged to ascertain the efficacy of XEN stent over the long term

Financial Disclosure:

None