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

E

EyeTechCare

Status

Conditions

Refractory Open Angle Glaucoma

Treatments

Procedure: high intensity focused ultrasound for cyclodestruction in the eye

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT01908985
EYEMUST-FLUO

Details and patient eligibility

About

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

Full description

Main outcome criteria:

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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