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
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
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
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
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Primary Completion Date
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Study Completion Date
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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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