Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

Glaucoma Clinical Trial

Official title:

Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791673
• Other study ID #: EYEMUST-3
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: June 15, 2015
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2013
• Source: EyeTechCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Ultrasound glaucoma treatment
Ultrasound glaucoma treatment with EYEOP1 device

Locations

Country	Name	City	State
France	University Hospital	Dijon
France	Michallon University Hospital	Grenoble
France	Huriez University Hospital	Lille
France	Croix Rousse University Hospital	Lyon
France	HIA - Val de Grace Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
EyeTechCare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%	Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)	up to 12 months	No
Secondary	Average change in IOP (mm Hg)		3, 6 and 12 months	No
Secondary	Percentage change in IOP from baseline		3, 6 and 12 months	No
Secondary	Average change in glaucoma hypotensive medications		3, 6 and 12 months	No
Secondary	Incidence of device and procedure-related complications during follow-up		3, 6 and 12 months	Yes