Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused … (NCT01908985) | Clinical Trial Compass
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Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.