Circular Cyclocoagulation Using HIFU With EYEOP1 Device i... | NCT01791673

Studies
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

NCT01791673

Sponsor

EyeTechCare

Status

Completed

Last Update Posted

Jun 16, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Ultrasound glaucoma treatment

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

Status Module

Record Verification Date

Feb 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

Nov 2012

Primary Completion Date

May 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Feb 13, 2013

First Submission Date that Met QC Criteria

Feb 13, 2013

First Posted Date

Feb 15, 2013Estimated

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 cyclocoagulation using HIFU in 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound Glaucoma treatment	Experimental	Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)	Device: Ultrasound glaucoma treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound glaucoma treatment	Device	Ultrasound glaucoma treatment with EYEOP1 device	Ultrasound Glaucoma treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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 University Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided