NCT01908985No Longer Available不适用
Ocular Fluorophotometry to Assess the Aqueous Humor Production for Patients With Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
EyeTechCare0 个研究点开始时间: 2013年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
研究概览
简要总结
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
详细描述
Main outcome criteria:
Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
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