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Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).

Primary Purpose

Refractory Open Angle Glaucoma

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
high intensity focused ultrasound for cyclodestruction in the eye
Sponsored by
EyeTechCare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Refractory Open Angle Glaucoma focused on measuring glaucoma, high intensity focused ultrasound, aqueous humor, fluorophotometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • refractory primary open-angle glaucoma (POAG)
  • IOP> 21 mm Hg and <32 mm Hg with an optimal treatment.
  • Lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...)
  • Lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of HIFU treatment.
  • Male or female age (s) of at least 18 and able to give informed consent
  • Patient who signed the informed consent form
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • History of glaucoma by placing a drainage implant (valves, pipes ...)
  • previous refractive procedures preventing accurate measurement of intraocular pressure (PRK, LASIK)
  • General treatment which may alter IOP began in the month before the HIFU procedure
  • Patient monophthalmus
  • thyroid orbitopathy
  • History of ocular or retrobulbar tumor
  • Cyclodialysis
  • choroidal hematoma or uprising choroidal
  • Anatomy of the eyeball inadequate treatment or medical device (eye too small or too large)
  • Pregnancy, breastfeeding, lack of contraceptive use among women at risk of having a child
  • Participation in another clinical investigation of a medical or surgical treatment can affect the intraocular pressure in the three months preceding the HIFU
  • Patient minor or major protected by law

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2013
    Last Updated
    July 17, 2019
    Sponsor
    EyeTechCare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01908985
    Brief Title
    Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
    Official Title
    Ocular Fluorophotometry to Assess the Aqueous Humor Production for Patients With Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EyeTechCare

    4. Oversight

    5. Study Description

    Brief Summary
    Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound. Population selected: - Patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma. The purpose of our study is: - To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry. Planning: First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase. Second phase: 6 patients
    Detailed Description
    Main outcome criteria: Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory Open Angle Glaucoma
    Keywords
    glaucoma, high intensity focused ultrasound, aqueous humor, fluorophotometry

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    high intensity focused ultrasound for cyclodestruction in the eye

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: refractory primary open-angle glaucoma (POAG) IOP> 21 mm Hg and <32 mm Hg with an optimal treatment. Lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...) Lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of HIFU treatment. Male or female age (s) of at least 18 and able to give informed consent Patient who signed the informed consent form Patient affiliated to a social security scheme Exclusion Criteria: History of glaucoma by placing a drainage implant (valves, pipes ...) previous refractive procedures preventing accurate measurement of intraocular pressure (PRK, LASIK) General treatment which may alter IOP began in the month before the HIFU procedure Patient monophthalmus thyroid orbitopathy History of ocular or retrobulbar tumor Cyclodialysis choroidal hematoma or uprising choroidal Anatomy of the eyeball inadequate treatment or medical device (eye too small or too large) Pregnancy, breastfeeding, lack of contraceptive use among women at risk of having a child Participation in another clinical investigation of a medical or surgical treatment can affect the intraocular pressure in the three months preceding the HIFU Patient minor or major protected by law

    12. IPD Sharing Statement

    Learn more about this trial

    Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).

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