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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EYEOP1 device

cyclocoagulation HIFU

Group Type EXPERIMENTAL

EYEOP1

Intervention Type DEVICE

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

Interventions

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EYEOP1

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No