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

July 17, 2019 updated by: EyeTechCare

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Main outcome criteria:

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

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeTechCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYEMUST-FLUO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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