Abstract
BACKGROUND: To compare the efficacy of phacoemulsification (PKE) combined with nonpenetrating deep sclerectomy (NPDS) with mitomycin C (MMC) versus XEN® gel stent with MMC. METHODS: In this nonrandomized, retrospective, comparative, single-center pilot study, 105 consecutive eyes of 75 patients with uncontrolled primary open-angle glaucoma (POAG) and cataract who underwent PKE combined with either XEN implantation (n = 47) or NPDS (n = 58) between May 2013 and November 2018 were included. The primary outcome was complete success at 9 months, which was defined as intraocular pressure (IOP) ≤18, 15 or 12 mmHg without treatment; qualified success was IOP ≤18, 15 or 12 mmHg with antiglaucoma medications. Secondary outcome measures included the number of antiglaucoma medications, visual acuity (VA), and postoperative adverse events. RESULTS: Using the 18 mmHg threshold, complete or qualified success was achieved in 69.6 and 89.1% in the PKE + XEN group, and 63.8 and 89.7% in the PKE + NPDS group (p = .54 and p = .93), respectively, at 9 months. The mean IOP decreased from 20.8 ± 6.8 mmHg to 16.2 ± 2.8 mmHg in the PKE + XEN group (p < .001, 18.9% mean drop), and from 21.5 ± 8.9 mmHg to 14.9 ± 3.9 mmHg in the PKE + NPDS group (p < .001, 25.6% mean drop). Best-corrected VA significantly improved (p < .001) in both groups. The mean number of antiglaucoma medications was significantly reduced from 2.66 ± 1.1 to 0.49 ± 1.0 in the PKE + XEN group (p < .001) and from 2.93 ± 0.9 to 0.69 ± 1.2 in the PKE + NPDS group (p < .001). CONCLUSIONS: The XEN stent combined with PKE seemed to be as effective and safe as PKE + NPDS at 9 months in this pilot study.