Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device

Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.

Inclusion Criteria:

• Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment
• Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg
• Subject has failed a conventional intraocular glaucoma filtering surgery
• Patient must be aged 18 years or more
• No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment
• No previous cyclophotocoagulation procedure in the study eye
• Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.

Exclusion Criteria:

• History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
• History of ocular or retrobulbar tumor
• Retinal detachment, choroidal hemorrhage or detachment
• Ocular infectious disease within 14 days before HIFU treatment