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

EyeTechCare

Status: Completed

Conditions: Glaucoma

Treatments: Device: EYEOP device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338467

2011-A00196-35 (Other Identifier)

EYEMUST

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

EYEOP Treatment

Experimental group

Description:

Open label, all subject treated by the EYEOP device

Treatment:

Device: EYEOP device