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CompletedNCT01338467Updated Jun 16, 2015

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

An interventional study of EYEOP device in Glaucoma, sponsored by EyeTechCare. Completed at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-16.

Sponsored by EyeTechCare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • Glaucoma
  • Refractory glaucoma
  • Cyclocoagulation
  • High Intensity Focused Ultrasound
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 52 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

EyeTechCare is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    EYEOP Treatment

    Open label, all subject treated by the EYEOP device

    Device: EYEOP device

Interventions

  • DeviceEYEOP device

    Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

06

What researchers measure

Primary outcomes

  1. Primary efficacy measure :

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

    Time frame: 6 months

Secondary outcomes

  1. Safety measures

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

    Time frame: 6 months

07

Study locations

9 sites
  • University Hospital
    Dijon, 21000, France
  • University Hospital
    Grenoble, 38000, France
  • University Hospital - Cl Huriez
    Lille, 59000, France
  • Clinique du Parc - Private Hospital
    Lyon, 69006, France
  • Croix Rousse Hospital
    Lyon, France
  • XV-XX National Ophthalmologic Hospital
    Paris, 75012, France
  • XV-XX Ophthalmologic Hospital
    Paris, 75012, France
  • Saint-Joseph Hospital
    Paris, 75014, France
  • Val de Grace Hospital
    Paris, 75235, France
08

References and documents

Publications

  • 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. PubMed 25604688 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01338467
Lead sponsor
EyeTechCare
Responsible party
Sponsor
First posted
Apr 19, 2011
Start date
Apr 2011
Primary completion
Jun 2012
Completion
Nov 2013
Last update
Jun 16, 2015

Study contacts

Philippe DENIS, MD
principal investigator · Croix Rousse Hospital - Lyon - France
Laurent FARCY
study director · EyeTechCare
Florent APTEL, MD
principal investigator · University Hospital - Grenoble - France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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