Status:
NO_LONGER_AVAILABLE
Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
Lead Sponsor:
EyeTechCare
Conditions:
Refractory Open Angle Glaucoma
Eligibility:
All Genders
18+ years
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 ultras...
Detailed Description
Main outcome criteria: Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01908985
Last Update
July 19 2019
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