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

Glaucoma Clinical Trial

Official title:

Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338467
• Other study ID #: EYEMUST
• Secondary ID: 2011-A00196-35
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: June 15, 2015
• Start date: April 2011
• Est. completion date: November 2013

Study information

• Verified date: March 2013
• Source: EyeTechCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : French Health Products Safety Agency (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2013
• Est. primary completion date: June 2012
• 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 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

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

Locations

Country	Name	City	State
France	University Hospital	Dijon
France	University Hospital	Grenoble
France	University Hospital - Cl Huriez	Lille
France	Clinique du Parc - Private Hospital	Lyon
France	Croix Rousse Hospital	Lyon
France	Saint-Joseph Hospital	Paris
France	Val de Grace Hospital	Paris
France	XV-XX National Ophthalmologic Hospital	Paris
France	XV-XX Ophthalmologic Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
EyeTechCare

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy measure :	IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment	6 months	No
Secondary	Safety measures	The incidence of device and procedure-related complications during the follow-up	6 months	Yes