Abstract
The new XEN63 implant is a minimally invasive glaucoma surgery device with limited experience in real life. This retrospective study included open-angle glaucoma patients who underwent XEN63 implant, either alone or in combination with cataract surgery. Primary endpoints were the intraocular pressure (IOP) at month 3 and the incidence of serious adverse events. Twenty-three eyes of 23 patients were included. Mean age was 67.8 ± 15.3 years and 15 (65.2%) were women. Mean IOP was significantly lowered from 27.0 ± 7.8 mmHg at baseline to 12.2 ± 3.4 mmHg at month 3 (p < 0.0001). Mean IOP lowering was 40.8 ± 23.5%, with 14 (60.9%) and 16 (69.6%) eyes achieving an IOP lowering ≥30% and ≥20% without hypotensive medication, respectively. The number of hypotensive medications (NHM) was significantly reduced from 2.27 ± 0.94 drugs at baseline to 0.09 ± 0.42 drugs at month 3, p < 0.0001. Four (17.4%) eyes had hypotony (IOP ≤ 6 mmHg) at postoperative day one, which was successfully resolved without sequelae. Four (17.4%) eyes had choroidal detachment (3 at day 7 and 1 at day 15), which was successfully resolved with medical treatment, at the month 1 visit. Three (13.0%) eyes required needling (mean time for needling 35.6 ± 9.7 days). XEN63 significantly lowered IOP and reduced the NHM, with a good short-term safety profile.
Highlights
The term glaucoma covers a wide range of multifactorial, chronic, and progressive optic neuropathies, characterized by progressive loss of retinal ganglion cells and subsequent visual field defects [1].Glaucoma is a leading cause of irreversible blindness, and is estimated to affect over 111 million people worldwide by 2040 [2].The main goal of glaucoma treatment is to slow the progression of the disease and to preserve, as much as possible, the patient quality of life.Up to now, decreasing intraocular pressure (IOP) has been the only proven method to treat glaucoma [3]
Each subject underwent a standard ophthalmic exam, which included a detailed medical history, anterior segment and fundus examination, best corrected visual acuity (BCVA), IOP measurement assessed at 9 am (±1 h) using Goldmann applanation tonometry, and gonioscopy
The post hoc power analyses was determined for an alpha level of 0.05, the study sample size, and the effect size observed in the study [22]
Summary
The term glaucoma covers a wide range of multifactorial, chronic, and progressive optic neuropathies, characterized by progressive loss of retinal ganglion cells and subsequent visual field defects [1]. The new XEN63 device is introduced by using a 27G needle, to the XEN45 stent. Since the outer diameter of XEN63 is greater than that of XEN45, the side flow with the XEN63 is reduced compared with the XEN45 (Figure 1). The former device wasdiameters inserted by a 25GXEN63, needle injector XEN63 and the the new XEN45 devices by using a 27G injector needle, the injector side flow with the greater. The new XEN63 device was developed for decreasing the incision site as compared to.
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