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OpenTrials
Completed

NCT Number: NCT01592955

Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)

The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device 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

Phase 4

Primary location

The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center, Tel Litwinsky, Israel

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Refractory Glaucoma
  • IOP > 21 mm Hg
  • No previous intraocular surgery or laser treatment during the 90 days before HIFU day
  • Age > 18 years
  • Informed consent sgned by the subject

Exclusion criteria

  • Normal Tension Glaucoma
  • Glaucoma drainage device implanted and still present in the eye to be treated
  • History of ocular or retrobulbar tumor
  • Ocular infection within 14 days prior to the HIFU procedure
  • Aphakic patient
  • Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
  • Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child

Treatment and study plan

EYEOP1

Device

Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

Primary outcomes

  1. Efficacy endpoint : Success / failure rate at 1 year

    Time frame: 12 months

    IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg)

Secondary outcomes

  1. Safety measures

    Time frame: 12 months

    Number of device and procedure-related and others complications during follow-up

Sponsors and collaborators

Lead sponsor

EyeTechCare

Industry

Registry information

Official study title

Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 7, 2012
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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