Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU 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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Ultrasound Glaucoma treatment

Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)

Group Type EXPERIMENTAL

Ultrasound glaucoma treatment

Intervention Type DEVICE

Ultrasound glaucoma treatment with EYEOP1 device

Interventions

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Ultrasound glaucoma treatment

Ultrasound glaucoma treatment with EYEOP1 device

Intervention Type DEVICE

Other Intervention Names

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UCP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No