Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

EyeTechCare

Status: Completed

Conditions: Glaucoma

Treatments: Device: Ultrasound glaucoma treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01791673

EYEMUST-3

Details and patient eligibility

About

The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma
• IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
• Patient must be aged 18 years and more
• No previous cyclophotocoagulation procedure in the eye
• No previous laser treatment in the eye during the 3 months before HIFU procedure

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 diseasee within 14 days before HIFU procedure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ultrasound Glaucoma treatment

Experimental group

Description:

Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)

Treatment:

Device: Ultrasound glaucoma treatment