Glaucoma Treatment by Circular Cyclocoagulation Using Hig... | NCT01338467

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

NCT01338467

Sponsor

EyeTechCare

Status

Completed

Last Update Posted

Jun 16, 2015Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

EYEOP device

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A00196-35	Other Identifier	French Health Product Safety Agency (AFSSAPS)

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 15, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2015

Last Update Posted Date

Jun 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EYEOP Treatment	Experimental	Open label, all subject treated by the EYEOP device	Device: EYEOP device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EYEOP device	Device	Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device	EYEOP Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety measures	The incidence of device and procedure-related complications during the follow-up	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe DENIS, MD	Croix Rousse Hospital - Lyon - France	Principal Investigator
Laurent FARCY	EyeTechCare	Study Director
Florent APTEL, MD	University Hospital - Grenoble - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Dijon		21000	France
University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25604688	Result	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. doi: 10.1167/iovs.14-14973.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases