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.