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

NCT01908985 | Unknown

• 1 other identifier: EYEMUST-FLUO
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Refractory Open Angle Glaucoma

Keywords

glaucoma; high intensity focused ultrasound; aqueous humor; fluorophotometry

Interventions

high intensity focused ultrasound for cyclodestruction in the eye PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeTechCare: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Last Updated: July 19, 2019

Record last verified: 2013-07