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The efficacy and safety of the XEN gel implant in POAG and PXG patients

Poster Details

First Author: M.Economou SWEDEN

Co Author(s):    R. Kasina                     

Abstract Details

Purpose:

The Xen implant (Allergan, Dublin, Ireland) is a 6mm porcine gelatin device that is implanted ab interno to the subconjuctival space under direct gonioscopic visualization. The purpose of this study is to investigate the safety and efficacy of the Xen implant alone or in combination with phacoemulsification in patients with medically uncontrolled glaucoma.

Setting:

The study was conducted at St Erik Eye Hospital at the Karolinska Institute in Stockholm, which is a tertiary referral center for glaucoma surgery serving the whole of Sweden.

Methods:

Retrospective chart review of total 45 eyes of 38 patients with POAG (Primary Open Angle Glaucoma) or PXG (Pseudoexfoliation Glaucoma)that underwent either implantation of Xen alone or in combination with cataract surgery. Primary outcome measures with one year follow-up included intra-operative and post-operative complications, visual acquity, intraocular pressure (IOP), and number of glaucoma medications.

Results:

15 eyes underwent combined phaco巩� procedure and 30 eyes only the Xen. Ten patients in the Xen alone group developed early hypotony (IOP<5mmHg). Mean preoperative IOP in the combined group was 23.7�Â�±4.1mmHg on 2.9�Â�±1.0 medications and in the Xen alone group 22.8�Â�±5.2 mmHg on 3.6�Â�±1.2 medications. Mean IOP was reduced to 17.4�Â�±3.4mmHg(p<0.05) and 0.5�Â�±0.8 medications (p<0.05) in the combined group and 15.2�Â�±4.6mmHg (p<0.05) in the Xen alone group at 1- year follow up on 0.3�Â�±0.9 (p<0.05) glaucoma medications. IOP lowering effect was 26.6% for the combined group and 33.6% for the Xen alone group. No major complications were observed.

Conclusions:

In this 1 year safety and feasibility assessment, the safety profile and efficacy data of the Xen implant both in combination with cataract surgery and alone are very promising. Further study with longer-term follow up and a larger number of patients are needed to fully assess the utility of this device.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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