NCT01338467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 16, 2015

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

April 15, 2011

Last Update Submit

June 15, 2015

Conditions

Glaucoma

Keywords

GlaucomaRefractory glaucomaCyclocoagulationHigh Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy measure :

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

    6 months

Secondary Outcomes (1)

  • Safety measures

    6 months

Study Arms (1)

EYEOP Treatment

EXPERIMENTAL

Open label, all subject treated by the EYEOP device

Device: EYEOP device

Interventions

EYEOP deviceDEVICE

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

EYEOP Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital

Dijon, 21000, France

Location

University Hospital

Grenoble, 38000, France

Location

University Hospital - Cl Huriez

Lille, 59000, France

Location

Clinique du Parc - Private Hospital

Lyon, 69006, France

Location

Croix Rousse Hospital

Lyon, France

Location

XV-XX National Ophthalmologic Hospital

Paris, 75012, France

Location

XV-XX Ophthalmologic Hospital

Paris, 75012, France

Location

Saint-Joseph Hospital

Paris, 75014, France

Location

Val de Grace Hospital

Paris, 75235, France

Location

Related 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. doi: 10.1167/iovs.14-14973.

    PMID: 25604688RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Philippe DENIS, MD

    Croix Rousse Hospital - Lyon - France

    PRINCIPAL INVESTIGATOR

  • Laurent FARCY

    EyeTechCare

    STUDY DIRECTOR

  • Florent APTEL, MD

    University Hospital - Grenoble - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 19, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

November 1, 2013

Last Updated

June 16, 2015

Record last verified: 2013-03

Locations

FR(9)