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OpenTrials
Completed

NCT Number: NCT01791673

Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in 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

Loading trial locations.

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
  • IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
  • Patient must be aged 18 years and more
  • No previous cyclophotocoagulation procedure in the eye
  • No previous laser treatment in the eye during the 3 months before HIFU procedure

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 diseasee within 14 days before HIFU procedure

Treatment and study plan

Ultrasound glaucoma treatment

Device

Ultrasound glaucoma treatment with EYEOP1 device

Other names: UCP

Primary outcomes

  1. Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%

    Time frame: up to 12 months

    Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)

Secondary outcomes

  1. Average change in IOP (mm Hg)

    Time frame: 3, 6 and 12 months

  2. Percentage change in IOP from baseline

    Time frame: 3, 6 and 12 months

  3. Average change in glaucoma hypotensive medications

    Time frame: 3, 6 and 12 months

  4. Incidence of device and procedure-related complications during follow-up

    Time frame: 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

EyeTechCare

Industry

Registry information

Official study title

Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 15, 2013
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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