Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Ultrasound glaucoma treatment

• Registration Number: NCT01791673
• Lead Sponsor: EyeTechCare

Brief Summary

The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Primary Completion: 2013-05
• Study Completion: 2014-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Glaucoma treatment	Ultrasound glaucoma treatment	Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)

Primary Outcome Measures

Name	Time	Method
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%	up to 12 months	Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)

Secondary Outcome Measures

Name	Time	Method
Average change in IOP (mm Hg)	3, 6 and 12 months
Percentage change in IOP from baseline	3, 6 and 12 months
Average change in glaucoma hypotensive medications	3, 6 and 12 months
Incidence of device and procedure-related complications during follow-up	3, 6 and 12 months

Trial Locations

Locations (5)

Croix Rousse University Hospital; 🇫🇷 Lyon, France

HIA - Val de Grace Hospital; 🇫🇷 Paris, France

Michallon University Hospital; 🇫🇷 Grenoble, France

University Hospital; 🇫🇷 Dijon, France

Huriez University Hospital; 🇫🇷 Lille, France