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

NCT ID: NCT01338467

Last Updated: 2015-06-16

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EYEOP Treatment

Open label, all subject treated by the EYEOP device

Group Type EXPERIMENTAL

EYEOP device

Intervention Type DEVICE

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

Interventions

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EYEOP device

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EyeTechCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe DENIS, MD

Role: PRINCIPAL_INVESTIGATOR

Croix Rousse Hospital - Lyon - France

Laurent FARCY

Role: STUDY_DIRECTOR

EyeTechCare

Florent APTEL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital - Grenoble - France

Locations

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University Hospital

Dijon, , France

Site Status

University Hospital

Grenoble, , France

Site Status

University Hospital - Cl Huriez

Lille, , France

Site Status

Clinique du Parc - Private Hospital

Lyon, , France

Site Status

Croix Rousse Hospital

Lyon, , France

Site Status

XV-XX National Ophthalmologic Hospital

Paris, , France

Site Status

XV-XX Ophthalmologic Hospital

Paris, , France

Site Status

Saint-Joseph Hospital

Paris, , France

Site Status

Val de Grace Hospital

Paris, , France

Site Status

Countries

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France

References

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Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.

Reference Type RESULT
PMID: 25604688 (View on PubMed)

Other Identifiers

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2011-A00196-35

Identifier Type: OTHER

Identifier Source: secondary_id

EYEMUST

Identifier Type: -

Identifier Source: org_study_id

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