Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)

EyeTechCare

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Device: EYEOP1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01592955

EYEMUST-2

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refractory Glaucoma
• IOP > 21 mm Hg
• No previous intraocular surgery or laser treatment during the 90 days before HIFU day
• Age > 18 years
• Informed consent sgned by the subject

Exclusion criteria

• Normal Tension Glaucoma
• Glaucoma drainage device implanted and still present in the eye to be treated
• History of ocular or retrobulbar tumor
• Ocular infection within 14 days prior to the HIFU procedure
• Aphakic patient
• Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
• Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

EYEOP1 device

Experimental group

Description:

cyclocoagulation HIFU

Treatment:

Device: EYEOP1