Antonio M Fea1, Alain M Bron, Mario A Economou, Gianluca Laffi, Enrico Martini, Michele Figus, Francesco Oddone. 1. From the Department of Surgical Sciences (Fea), Eye Clinic, University Hospital, Turin, Department of Ophthalmology (Laffi), S. Orsola Hospital, Bologna, Department of Ophthalmology (Martini), Sassuolo Hospital, Sassuolo, Department of Surgical, Medical, Molecular Pathology, and Critical Area (Figus), University of Pisa, Pisa, IRCCS GB Bietti Foundation (Oddone), Rome, Italy; Department of Ophthalmology, University Hospital (Bron), Dijon, France; and St Erik Eye Hospital (Economou), Karolinska Institute, Stockholm, Sweden.
Abstract
PURPOSE: To investigate the efficacy and safety of a cross-linked gel stent (XEN45) with or without cataract surgery in the treatment of glaucoma patients. SETTING:Five university hospitals. DESIGN: Prospective multicenter clinical trial. METHODS:Patients with glaucoma inadequately controlled by treatment or poor compliance or intolerance to topical therapy were included. Patients were divided into those who had an implant only (Solo Group; phakic and pseudophakic patients) and those who had an implant combined with cataract surgery (Combo Group). Differences in mean intraocular pressure (IOP) and number of medications between the baseline preoperative visit and study end (12 months), and the rate of qualified and complete success, were evaluated. RESULTS: The Solo Group comprised 115 glaucoma patients (43 phakic and 72 pseudophakic) and the Combo Group comprised 56 patients. Compared with baseline, mean IOP (23.9 ± 7.6 to 15.5 ± 3.9) and number of medications (3.0 ± 1.1 to 0.5 ± 1.0) decreased significantly at 12-month follow-up (P < .001 for both). A >20% and >30% reduction in IOP from baseline was achieved by 72.3% and 52.6% of patients, respectively. IOP at 1 week postoperatively was a predictor of success, and the needling rate was inversely correlated with early postoperative IOP. The number of preoperative medications and patient age were not significantly associated with failure. CONCLUSIONS: Insertion of a cross-linked gel stent alone or combined with phacoemulsification might be effective and safe in the treatment of open-angle glaucoma, with a substantial reduction in IOP and number of medications.
RCT Entities:
PURPOSE: To investigate the efficacy and safety of a cross-linked gel stent (XEN45) with or without cataract surgery in the treatment of glaucomapatients. SETTING: Five university hospitals. DESIGN: Prospective multicenter clinical trial. METHODS:Patients with glaucoma inadequately controlled by treatment or poor compliance or intolerance to topical therapy were included. Patients were divided into those who had an implant only (Solo Group; phakic and pseudophakic patients) and those who had an implant combined with cataract surgery (Combo Group). Differences in mean intraocular pressure (IOP) and number of medications between the baseline preoperative visit and study end (12 months), and the rate of qualified and complete success, were evaluated. RESULTS: The Solo Group comprised 115 glaucomapatients (43 phakic and 72 pseudophakic) and the Combo Group comprised 56 patients. Compared with baseline, mean IOP (23.9 ± 7.6 to 15.5 ± 3.9) and number of medications (3.0 ± 1.1 to 0.5 ± 1.0) decreased significantly at 12-month follow-up (P < .001 for both). A >20% and >30% reduction in IOP from baseline was achieved by 72.3% and 52.6% of patients, respectively. IOP at 1 week postoperatively was a predictor of success, and the needling rate was inversely correlated with early postoperative IOP. The number of preoperative medications and patient age were not significantly associated with failure. CONCLUSIONS: Insertion of a cross-linked gel stent alone or combined with phacoemulsification might be effective and safe in the treatment of open-angle glaucoma, with a substantial reduction in IOP and number of medications.
Authors: Néstor Ventura-Abreu; Julián García-Feijoo; Marta Pazos; Marc Biarnés; Laura Morales-Fernández; José María Martínez-de-la-Casa Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-04-27 Impact factor: 3.117
Authors: Huub J Poelman; Jan Pals; Parinaz Rostamzad; Wichor M Bramer; Roger C W Wolfs; Wishal D Ramdas Journal: J Clin Med Date: 2021-03-07 Impact factor: 4.241