June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Performance of a new ab interno gelatin stent in refractory glaucoma and 18-month safety results
Author Affiliations & Notes
  • Davinder Singh Grover
    Glaucoma Associates of Texas, Dallas, Texas, United States
  • William J Flynn
    Rashid Rice & Flynn Eye Associates, San Antonio, Texas, United States
  • Kent P Bashford
    Eye Center of Northern Colorado, Fort Collins, Colorado, United States
  • Arsham Sheybani
    Washington University School of Medicine, St. Louis, Missouri, United States
  • Yi-Jing Duh
    StatServe Consulting Inc., Chino Hills, California, United States
  • Barbara Niksch
    Allergan plc, Irvine, California, United States
  • Footnotes
    Commercial Relationships   Davinder Grover, Allergan plc (C), Allergan plc (R), Reichert Technologies (R); William Flynn, Allergan plc (F); Kent Bashford, Aerie Pharmaceuticals (F), Allergan plc (F), Glaukos Corp. (F), Ivantis, Inc. (F), Transcend Medical, Inc. (F); Arsham Sheybani, Allergan plc (C); Yi-Jing Duh, Allergan plc (C); Barbara Niksch, Allergan plc (E)
  • Footnotes
    Support  Allergan plc
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4936. doi:
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      Davinder Singh Grover, William J Flynn, Kent P Bashford, Arsham Sheybani, Yi-Jing Duh, Barbara Niksch; Performance of a new ab interno gelatin stent in refractory glaucoma and 18-month safety results. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4936.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Nonadherence to treatments requiring daily dosage is common in chronic, asymptomatic diseases such as glaucoma and has been linked to worse outcomes. This multicenter study assessed the intraocular pressure (IOP)-lowering performance and safety of an ab interno placed gelatin stent (XEN®45, Allergan plc).

Methods : Patients (≥45 y old) with refractory glaucoma (ie, history of failed filtering/cilioablative procedure or uncontrolled IOP on maximum-tolerated topical therapy), medicated IOP ≥20 and ≤35 mmHg, and visual field mean deviation ≤-3 dB were implanted with the 6-mm gelatin stent. Primary outcomes: patients (%) achieving ≥20% IOP reduction from baseline on the same or fewer medications, and mean IOP change from baseline at 12 months. Procedure-related complications and ocular adverse events (AEs) were assessed at 18 months.

Results : 65 patients received the stent (intent-to-treat population); 83.1% and 75.4% completed the 12- and 18-month visits, respectively. At baseline, 84.6% of patients had failed a prior glaucoma procedure, 69.2% had undergone cataract surgery, and mean medicated IOP ± standard deviation (SD) was 25.1±3.7 mmHg. At 12 months, 76.3% of patients achieved ≥20% IOP lowering from baseline on the same or fewer medications; mean IOP change was -6.4 mmHg (95% CI: -8.8, -4.0). Observed data yielded similar results (n=61). Mean ± SD medication count fell from 3.5±1.0 (baseline) to 1.7±1.5 (12 months). No intraoperative complications or unexpected postoperative AEs were reported. Most AEs were mild or moderate and transient. Sixteen (24.6%) patients experienced transient hypotony (IOP <6 mmHg) requiring no surgical intervention. One case of stent exposure (after an implant repositioning procedure) was repaired at approximately 8 months postsurgery, without further complications. There were no cases of hypotony, migration, exposure, endophthalmitis, or unanticipated AEs after the 12-month visit. Overall, needling was performed in 24 (36.9%) patients (21 had no complications, 1 had transient hypotony, and 2 had worsening of biomicroscopy findings) and 14 (21.5%) patients underwent another glaucoma procedure or device explant.

Conclusions : Ab interno placement of the gelatin stent reduced IOP and medication use without unexpected safety concerns over 18 months, confirming this approach as a surgical option in patients with refractory glaucoma.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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