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

Refractory Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01908985
• Other study ID #: EYEMUST-FLUO
• Status: No longer available

Study information

• Verified date: July 2013
• Source: EyeTechCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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

Description:

Main outcome criteria:

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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Refractory Open Angle Glaucoma

Intervention

Procedure:
• high intensity focused ultrasound for cyclodestruction in the eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EyeTechCare