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Prospective Evaluation of Standalone XEN Gel Implant and Combined Phacoemulsification-XEN Gel Implant Surgery: 1-Year Results

2017; Lippincott Williams & Wilkins; Volume: 27; Issue: 2 Linguagem: Inglês

10.1097/ijg.0000000000000858

1536-481X

Kaweh Mansouri, Jacopo Guidotti, Harsha L. Rao, Adel Ouabas, Elisa D’Alessandro, Sylvain Roy, André Mermoud,

Corneal surgery and disorders

To evaluate the safety and efficacy of XEN gel implant (Allergan Inc., Irvine) as a standalone versus combined XEN-Phacoemulsification surgery (XEN+cataract) in glaucoma patients.Prospective, interventional study. One-hundred forty-nine eyes (113 patients) with open-angle glaucoma and uncontrolled intraocular pressure (IOP) despite medical treatment were enrolled at a tertiary glaucoma center and followed up for a minimum of 1 year. Approximately two-thirds of patients underwent combined XEN+cataract surgery, while the remainder had XEN alone surgery. Primary outcome was a 20% or more decrease in IOP from medicated baseline at 1 year. Mean IOP, mean number of medications at last follow-up, and incidence of adverse effects were analyzed.Of 149 enrolled eyes, data of 87 (58%) were available at 1 year. A total of 109 (73.2%) eyes underwent XEN+cataract surgery and 40 (26.8%) XEN alone surgery. Mean medicated IOP was 20.0±7.1 at baseline and 13.9±4.3 mm Hg at 1 year (P<0.01), a 31% IOP reduction. Mean medications dropped from 1.9±1.3 preoperatively to 0.5±0.8 at 1 year (P<0.001). In total, 62.1% of patients achieved a ≥20% IOP reduction; this proportion was higher in the XEN alone group. 57.7% of eyes achieved complete success (without any antiglaucoma medications) and 71.1% qualified success (with or without medications) when IOP<16 mm Hg was considered as the definition of success. In all, 37% of patients required needling intervention. Adverse effects included bleb revision in 5 eyes, choroidal detachment in 2 eyes, and second glaucoma surgery in 9 eyes.The XEN gel implant as a standalone procedure or combined with cataract surgery demonstrated safe and sustained IOP reduction after 1 year.