Philippe Denis1, Florent Aptel2, Jean-François Rouland3, Jean-Philippe Nordmann4, Yves Lachkar5, Jean-Paul Renard6, Eric Sellem7, Christophe Baudouin8, Alain Bron9. 1. Hôpital de la Croix-Rousse, Service d'Ophtalmologie, Hospices Civils de Lyon, Lyon, France. 2. Service d'Ophtalmologie, Centre Hospitalier Universitaire de Grenoble, Grenoble, France. 3. Service d'Ophtalmologie, Hôpital Claude Huriez, CHRU de Lille, Lille, France. 4. Service d'Ophtalmologie 3, Centre Hospitalier National des Quinze-Vingts, Paris, France. 5. Institut du Glaucome, Fondation Hôpital Saint-Joseph, Paris, France. 6. Service d'Ophtalmologie, Hôpital d'Instruction des Armées du Val de Grâce, Paris, France. 7. Centre Ophtalmologique Kléber, Lyon, France. 8. Service d'Ophtalmologie 2, Centre Hospitalier National des Quinze-Vingts, Paris, France. 9. Service d'Ophtalmologie, Hôpital Général, Dijon, France.
Abstract
PURPOSE: To evaluate the safety and efficacy of high-intensity focused ultrasound (HIFU) cyclocoagulation in reducing intraocular pressure (IOP) in patients with refractory glaucoma by using a novel miniaturized delivery device (EyeOP1). METHODS: We conducted a 12-month open-label multicenter prospective study (EyeMUST1 Study). Patients with primary (primary open-angle glaucoma [POAG]) or secondary refractory glaucoma were treated in two groups depending on the duration of each ultrasound shot (group 1: 4 seconds; group 2: 6 seconds). The primary efficacy outcome was based on IOP reduction at 6 and 12 months. RESULTS:Fifty-two patients were enrolled: 36 (69%) had POAG and 16 (31%) had secondary glaucoma. Group 1 (n = 24) and group 2 (n = 28) had similar demographics and baseline characteristics. In group 1, IOP was reduced from a mean preoperative value of 29.7 ± 7.7 mm Hg (n = 3.5 glaucoma medications) to a mean postoperative value of 21.3 ± 6.7 mm Hg (n = 3.5 glaucoma medications) and 20.1 ± 6.7 mm Hg (n = 3.2 glaucoma medications) at 6 and 12 months, respectively. In group 2, IOP was reduced from a mean preoperative value of 29.0 ± 7.4 mm Hg (n = 3.3 glaucoma medications) to a mean postoperative value of 20.2 ± 7.4 mm Hg (n = 3.4 glaucoma medications) and 18.5 ± 6.6 mm Hg (n = 3.5 glaucoma medications) at 6 and 12 months, respectively. At 12 months, the IOP reduction was sustained in both groups (32% IOP reduction in group 1 and 36% IOP reduction in group 2). The overall tolerance of the technique was good, with no serious adverse events. CONCLUSIONS: The new miniaturized HIFU EyeOP1 delivery device seems to be effective in decreasing IOP in patients with refractory glaucoma. The technology offers a good safety profile. (ClinicalTrials.gov number, NCT01338467.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
RCT Entities:
PURPOSE: To evaluate the safety and efficacy of high-intensity focused ultrasound (HIFU) cyclocoagulation in reducing intraocular pressure (IOP) in patients with refractory glaucoma by using a novel miniaturized delivery device (EyeOP1). METHODS: We conducted a 12-month open-label multicenter prospective study (EyeMUST1 Study). Patients with primary (primary open-angle glaucoma [POAG]) or secondary refractory glaucoma were treated in two groups depending on the duration of each ultrasound shot (group 1: 4 seconds; group 2: 6 seconds). The primary efficacy outcome was based on IOP reduction at 6 and 12 months. RESULTS: Fifty-two patients were enrolled: 36 (69%) had POAG and 16 (31%) had secondary glaucoma. Group 1 (n = 24) and group 2 (n = 28) had similar demographics and baseline characteristics. In group 1, IOP was reduced from a mean preoperative value of 29.7 ± 7.7 mm Hg (n = 3.5 glaucoma medications) to a mean postoperative value of 21.3 ± 6.7 mm Hg (n = 3.5 glaucoma medications) and 20.1 ± 6.7 mm Hg (n = 3.2 glaucoma medications) at 6 and 12 months, respectively. In group 2, IOP was reduced from a mean preoperative value of 29.0 ± 7.4 mm Hg (n = 3.3 glaucoma medications) to a mean postoperative value of 20.2 ± 7.4 mm Hg (n = 3.4 glaucoma medications) and 18.5 ± 6.6 mm Hg (n = 3.5 glaucoma medications) at 6 and 12 months, respectively. At 12 months, the IOP reduction was sustained in both groups (32% IOP reduction in group 1 and 36% IOP reduction in group 2). The overall tolerance of the technique was good, with no serious adverse events. CONCLUSIONS: The new miniaturized HIFU EyeOP1 delivery device seems to be effective in decreasing IOP in patients with refractory glaucoma. The technology offers a good safety profile. (ClinicalTrials.gov number, NCT01338467.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
Authors: Giuseppe Giannaccare; A Vagge; C Gizzi; A Bagnis; S Sebastiani; C Del Noce; M Fresina; C E Traverso; E C Campos Journal: Graefes Arch Clin Exp Ophthalmol Date: 2016-12-03 Impact factor: 3.117
Authors: Anna I Dastiridou; Andreas Katsanos; Philippe Denis; Brian A Francis; Dimitrios G Mikropoulos; Miguel A Teus; Anastasios-Georgios Konstas Journal: Adv Ther Date: 2018-11-17 Impact factor: 3.845