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

Sponsor

EyeTechCare (Industry)

Overall Status

No longer available

CT.gov ID

NCT01908985

Collaborator

(none)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Refractory Open Angle Glaucoma	Procedure: high intensity focused ultrasound for cyclodestruction in the eye

Detailed Description

Main outcome criteria:

Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.

Study Design

Study Type:

Expanded Access

Official Title:

Ocular Fluorophotometry to Assess the Aqueous Humor Production for Patients With Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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