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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EYEOP device
Sponsored by
EyeTechCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Refractory glaucoma, Cyclocoagulation, High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital
  • University Hospital
  • University Hospital - Cl Huriez
  • Clinique du Parc - Private Hospital
  • Croix Rousse Hospital
  • XV-XX National Ophthalmologic Hospital
  • XV-XX Ophthalmologic Hospital
  • Saint-Joseph Hospital
  • Val de Grace Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EYEOP Treatment

Arm Description

Open label, all subject treated by the EYEOP device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety measures
The incidence of device and procedure-related complications during the follow-up

Full Information

First Posted
April 15, 2011
Last Updated
June 15, 2015
Sponsor
EyeTechCare
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1. Study Identification

Unique Protocol Identification Number
NCT01338467
Brief Title
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeTechCare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Refractory glaucoma, Cyclocoagulation, High Intensity Focused Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EYEOP Treatment
Arm Type
Experimental
Arm Description
Open label, all subject treated by the EYEOP device
Intervention Type
Device
Intervention Name(s)
EYEOP device
Intervention Description
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
Primary Outcome Measure Information:
Title
Primary efficacy measure :
Description
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety measures
Description
The incidence of device and procedure-related complications during the follow-up
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DENIS, MD
Organizational Affiliation
Croix Rousse Hospital - Lyon - France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent FARCY
Organizational Affiliation
EyeTechCare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Florent APTEL, MD
Organizational Affiliation
University Hospital - Grenoble - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
University Hospital - Cl Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Clinique du Parc - Private Hospital
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Croix Rousse Hospital
City
Lyon
Country
France
Facility Name
XV-XX National Ophthalmologic Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
XV-XX Ophthalmologic Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Saint-Joseph Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Val de Grace Hospital
City
Paris
ZIP/Postal Code
75235
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25604688
Citation
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.
Results Reference
result

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

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