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 ( < 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, < 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.
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http://dx.doi.org/10.3390/jcm10081628 | DOI Listing |
Eur J Ophthalmol
January 2025
Eye Clinic, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.
Purpose: To evaluate the incidence and to describe the characteristics of the intrableb pigmentation (IBP) following XEN63 implantation.
Methods: Retrospective case series of three eyes presenting a pigment dispersion in the filtering bleb after a XEN63 implantation for uncontrolled IOP. Demographic, clinical and imaging data were obtained from medical records.
J Curr Glaucoma Pract
July 2024
Royal Free London NHS Foundation Trust, London, United Kingdom; Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.
Purpose: This case report describes the possibility of XEN63 lumen obstruction at the middle of the device and emphasizes the potential to restore its flow using an ab-externo revision technique involving a 10-0 nylon suture probe, before considering more aggressive surgical interventions.
Methods: A 55-year-old female with uveitic glaucoma underwent XEN63 implantation but experienced elevated intraocular pressure (IOP) (35 mm Hg) 1 month after the operation, despite medical therapy. A flat bleb, lack of response to medication, yttrium aluminum garnet (YAG) laser treatment, and slit-lamp needling necessitated revision.
J Clin Med
April 2024
Department of Surgical Sciences, Eye Clinic, University of Cagliari, 09124 Cagliari, Italy.
This study aimed to compare keratometry and anterior chamber depth (ACD) changes after XEN implantation in primary open-angle glaucoma (POAG) cases over a 3-month follow-up period. Twenty patients with POAG who underwent XEN63 implantation, either standalone or combined with cataract surgery, were included. Preoperative data, including best-corrected visual acuity (BCVA), refraction, gonioscopy, ophthalmoscopy, intraocular pressure (IOP) evaluation, and axial length, were collected.
View Article and Find Full Text PDFExpert Rev Med Devices
April 2024
Department of Ophthalmology, Faculty of Medicine, Hashemite University, Zarqa, Jordan.
Introduction: The XEN Gel, a hydrophilic tube meticulously crafted to adhere to the principles of the Hagen - Poiseuille law, is designed to facilitate efficient aqueous shunting without inducing hypotony. Implantable ab interno or ab externo, with or without conjunctival opening, the device shows no significant outcome differences. Despite numerical hypotony signaling failure, patients may fare well below 6 mmHg.
View Article and Find Full Text PDFSci Rep
February 2024
Ophthalmology Department, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.
This paper evaluates the effectiveness and safety of XEN63 stent, either standalone or in combination with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Eighty eyes from 80 patients with medically uncontrolled POAG were assigned to undergo XEN63 implant. The primary outcome was the surgical success, defined as an intraocular pressure (IOP) lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications.
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