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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Device: EYEOP1

• Registration Number: NCT01592955
• Lead Sponsor: EyeTechCare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Status Verified: 2013-03
• Primary Completion: 2014-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EYEOP1 device	EYEOP1	cyclocoagulation HIFU

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint : Success / failure rate at 1 year	12 months	IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction \> 20% compared to the baseline IOP or IOP \< 21 mmHg)

Secondary Outcome Measures

Name	Time	Method
Safety measures	12 months	Number of device and procedure-related and others complications during follow-up

Trial Locations

Locations (7)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Ospedale San Paolo; 🇮🇹 Milano, Italy

Institute Ophthalmology - Universita di Parma; 🇮🇹 Parma, Italy

Clinica Oculistica Universitaria - P-O Oftalmico; 🇮🇹 Torino, Italy

Clinique de Montchoisi - Glaucoma center; 🇨🇭 Lausanne, Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Genève, Switzerland

The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel