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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. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
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).
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.
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.
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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