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OpenTrials
Completed

NCT Number: NCT01338467

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EYEOP device

Device

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

Primary outcomes

  1. Primary efficacy measure :

    Time frame: 6 months

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

Secondary outcomes

  1. Safety measures

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

EyeTechCare

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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