Safety and efficacy outcomes of the Xen45 Gel Stent use for refractory glaucoma:a surgery series from surgeon trainees at a tertiary teaching hospital  

作　　者：Karen Hong John Lind Arsham Sheybani 

机构地区：[1]Department of Ophthalmology and Visual Sciences,Washington University School of Medicine,St.Louis,MO,USA [2]Barnes-Jewish Center for Outpatient Health,4901 Forest Park Avenue,St Louis,MO 63110,USA

出　　处：《Eye and Vision》2020年第1期47-57,共11页眼视光学杂志（英文）

基　　金：This study was sponsored by Allergan,Inc.through an investigator-initiated research grant.

摘　　要：Background:To study the effect of an ab interno gelatin stent(XEN45 Gel Stent,Allergan Inc.,Irvine,California,USA)on intraocular pressure(IOP)as placed by glaucoma fellowship trainees in eyes with refractory glaucoma.Methods:A prospective noncomparative study at a tertiary training center on 28 unique eyes undergoing ab interno gelatin stent implantation by glaucoma fellowship trainees.Data was collected at baseline and postoperatively at day 1,week 1,and months 1,3,5,and 12.Primary outcome was mean IOP change.Secondary outcomes included change in number of glaucoma medication classes and visual acuity.Safety outcomes included needling rates.Surgical success was defined by achieving≥20%reduction in IOP with the same or fewer classes of antiglaucoma medications from baseline without the need for secondary surgical intervention and/or stent removal.Results:At baseline,28.6%(8/28)of the subjects had prior failed incisional glaucoma surgery in a study population that was 54%African-American,with 78%with severe glaucoma(average mean deviation of−14.58 dB).Thirteen subjects terminated their clinic visits before their 12-month postoperative visit,leaving 15 subjects for end point analysis.Average IOP went from 21.6 mmHg(range 12.0–31.0,SD 6.6)at baseline to 12.5 mmHg(range 7.0–19.0,SD 3.6),a 42.1%reduction(p<0.007).All subjects decreased the number of medication classes they were taking with an average reduction of 3.8(range 2–5,SD 0.9)to 1.3(range 0–3,SD 1.0)classes,or a 65.8%decrease(p<0.006).Crude surgical success was 80.0%for the 15 subjects that followed up at 12 months.The Kaplan-Meier cumulative probability of success for all 28 subjects at 12 months was 70.4%(95%CI:44.7–85.8%).Regardless of the length of follow-up,21.4%(6/28)met failure criteria:3 subjects failed because they required secondary surgical intervention,and the other 3 did not have adequate IOP reduction.Initial bleb needling rate was 28.6%(8/28)and repeat was 17.9%(5/28).Conclusions:Compared to the reported literature with experienced

关 键 词：XEN Investigational devices Glaucoma Gelatin stent Ab interno surgery Minimally invasive glaucoma surgery Subconjunctival drainage Gelatin microstent 

分 类 号：R779.6[医药卫生—眼科] R775[医药卫生—临床医学]