Abstract

Purpose: To evaluate the intraocular pressure (IOP) lowering and safety profiles of the Xen45 Gel Stent implantation with preoperative Mitomycin C injection during a 6 months follow-up in patients with primary open-angle glaucoma (POAG). 
 Materials and Methods: Records of fourteen eyes of 13 POAG patients who underwent surgery with XEN45 Gel Stent combined with phacoemulsification were evaluated retrospectively. IOP changes, all complications and additional procedures during follow-up period were evaluated. Primary outcome measure was IOP, and the IOP target for complete success was defined as a postoperative IOP drop of more than 20% from preoperative baseline and IOP≥6 and ≤21 at 6 months without any glaucoma medications and qualified success was defined as a postoperative IOP reduction of more than 20% and IOP≥6 and ≤21 at 6 months with or without medications. 
 Results: Mean preoperative medicated IOP was 28.4 ± 2.7 mmHg with a mean of 2.6 ± 0.6 topical anti-glaucoma molecules. After 6 month follow-up period, mean IOP decreased to 17.8 ± 1.5 mmHg (mean IOP reduction of 37%) on 0.4 ± 1.1 antiglaucoma molecules. The complete success rate after 6 months was achieved in 42.8 % and qualified success in 85.7. Totally only 2 (14.2 %) patients required additional procedure (1 needling and 1 trabeculectomy). 
 Conclusions: The study showed that the XEN45 Gel Stent implantation combined with phaco-cataract surgery is an effective surgical method in POAG in case of uncontrolled IOP with a favorable safety profile and low complication rate.

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