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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: EYEOP device

• Registration Number: NCT01338467
• Lead Sponsor: EyeTechCare

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2012-06
• Status Verified: 2013-03
• Study Completion: 2013-11
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EYEOP Treatment	EYEOP device	Open label, all subject treated by the EYEOP device

Primary Outcome Measures

Name	Time	Method
Primary efficacy measure :	6 months	IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment

Secondary Outcome Measures

Name	Time	Method
Safety measures	6 months	The incidence of device and procedure-related complications during the follow-up

Trial Locations

Locations (8)

Saint-Joseph Hospital; 🇫🇷 Paris, France

XV-XX Ophthalmologic Hospital; 🇫🇷 Paris, France

XV-XX National Ophthalmologic Hospital; 🇫🇷 Paris, France

University Hospital; 🇫🇷 Grenoble, France

Val de Grace Hospital; 🇫🇷 Paris, France

Clinique du Parc - Private Hospital; 🇫🇷 Lyon, France

University Hospital - Cl Huriez; 🇫🇷 Lille, France

Croix Rousse Hospital; 🇫🇷 Lyon, France