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

Primary Purpose

Refractory Open Angle Glaucoma

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

high intensity focused ultrasound for cyclodestruction in the eye

About this trial

This is an expanded access trial for Refractory Open Angle Glaucoma focused on measuring glaucoma, high intensity focused ultrasound, aqueous humor, fluorophotometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01908985

First Posted

July 24, 2013

Last Updated

July 17, 2019

Sponsor

EyeTechCare

1. Study Identification

Unique Protocol Identification Number

NCT01908985

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EyeTechCare

4. Oversight

5. 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

Detailed Description

Main outcome criteria: Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Open Angle Glaucoma

Keywords

glaucoma, high intensity focused ultrasound, aqueous humor, fluorophotometry

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

high intensity focused ultrasound for cyclodestruction in the eye

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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