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Clinical Trials/NCT01338467
NCT01338467CompletedNot Applicable

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

EyeTechCare16 sites in 1 country52 target enrollmentStarted: April 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
16
Primary Endpoint
Primary efficacy measure :

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

  • 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

Arms & Interventions

EYEOP Treatment

Experimental

Open label, all subject treated by the EYEOP device

Intervention: EYEOP device (Device)

Outcomes

Primary Outcomes

Primary efficacy measure :

Time Frame: 6 months

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

Secondary Outcomes

  • Safety measures(6 months)

Investigators

Sponsor
EyeTechCare
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (16)

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